NIDDK Challenge Grants

American Recovery and Reinvestment Act of 2009
NIH Challenge Grants in Health and Science Research (RFA-OD-09-003)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH has received new funds for Fiscal Years 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act), Pub. L. No. 111-5. The NIH has designated at least $200 million in FYs 2009 – 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research

This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds.

The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Each NIH Institute, Center, and Office has selected specific Challenge Topics within the broad Challenge Areas related to its mission. The research in these Challenge Areas should have a high impact in biomedical or behavioral science and/or public health.

NIH anticipates funding 200 or more grants, each of up to $1 million in total costs, pending the number and quality of applications and availability of funds. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: “a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy.” Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.

The application due date is April 27, 2009.

Broad Challenge Areas and Specific Challenge Topics

Note: Those marked with an asterisk (*) are the highest priority topics; however, applicants may apply to any of the topics.

For NIDDK, the Challenge Topics are:

(01) Behavior, Behavioral Change, and Prevention

01-DK-101 Behavioral research in NIDDK diseases. Evidenced based medical management is essential to disease prevention and treatment but optimizing health outcomes also requires attention to non-biomedical factors in the individual, healthcare setting, and community. Basic and applied research is needed to examine the behavioral, cognitive, affective, interpersonal/social, and environmental factors that influence disease onset, course and complications. Where applicable, research should also examine the interaction between these factors and the biomedical aspects of disease (e.g. genetics, medication use and effectiveness, and physiologic/neural functioning). Contact: Dr. Christine Hunter, 301-594-4728, hunterchristine@mail.nih.gov.

01-DK-102 Discovery of behavioral mechanisms relevant to obesity. There is a gap in knowledge about basic behavioral aspects of obesity which limits the development of novel clinical approaches to obesity prevention and treatment. Basic behavioral research is needed to uncover the mechanisms and pathways of eating and activity related decision making, preferences, and behavioral response in humans. Where relevant, targets of research should include study of the interaction between biological factors (e.g. genetics, sensory or neural processing, and sleep) and behavioral, psychological, cognitive, economic, and social factors relevant to obesity. Research is sought that targets critical periods of obesity risk across the lifespan. Contact: Dr. Christine Hunter, 301-594-4728, hunterchristine@mail.nih.gov.

01-DK-103 Improved understanding of behavioral and social factors related to non-Adherence in people with diabetes: Optimal management of diabetes requires adherence to a complex and ongoing regimen that often includes attention to medication, blood glucose monitoring, diet, physical activity, other self-management behaviors, and medical monitoring. However, adherence to one or many of the recommendations for optimal care is also a complex process and requires attention to factors such as the interaction between patient and provider, patient preferences and cultural values, health literacy, economic factors and competing life demands. Basic behavioral and social science research is needed to better understand the factors that influence adherence and identify potential targets for intervention to improve diabetes relevant adherence. Contact: Dr. Christine Hunter, 301-594-4728, hunterchristine@mail.nih.gov

(02) Bioethics

02-DK-101 Ethical issues related to genetic and epignetic information – Genotype and genome-wide association studies, as well as the large databases containing this information for many individuals create a series of challenging ethical issues. In genome wide epigenetic studies have the potential to identify specific environmental exposures linked to genotyped individuals. Relevant studies will address issues such as recontact, return of research results and incidental findings, informed consent in the context of possible identifiability, and implications for related individuals for diseases that fall within the scope of the NIDDK mission. Contact: Dr. Rebekah Rasooly, 301.594.6007, rasoolyr@mail.nih.gov

02-DK-102 Informed consent - Evolving research paradigms using large databases of genomic and health information and the growth of personalized medicine challenge long-held assumptions about informed consent. New paradigms of informed consent should be developed for individuals with diseases within the scope of the NIDDK mission. Contact: Dr. Rebekah Rasooly, 301.594.6007, rasoolyr@mail.nih.gov.

02-DK-103 Unique issues posed by emerging technologies - Identify how emerging technologies, in areas such as biotechnology, tissue engineering, nanomedicine, and synthetic biology, raise unique ethical concerns related to dual use research, privacy, safety, intellectual property, commercialization and conflict of interest, among others. Assess how these novel issues are adequately addressed under current oversight and regulatory structures, and identify where there may be gaps and/or need for revised or new oversight approaches focusing specifically on studies of diseases within the scope of the NIDDK mission. Contact: Dr. Rebekah Rasooly, 301.594.6007, rasoolyr@mail.nih.gov.

02-DK-104 Enhancing privacy and confidentiality in electronically shared information - Identify novel approaches for enhancing the privacy, confidentiality and data security of health information that is shared electronically on diseases that fall within the scope of the NIDDK mission, especially within minority populations. Examination could include analysis of current oversight paradigms and suggestions for enhancements, as well as assessment of current and future privacy risks. The challenges of sharing health information in U.S. projects involving international collaborations should also be explored. Contact: Dr. Paul Eggers, 301 594-8305, eggersp@extra.niddk.nih.gov.

02-DK-105 Allocation of scarce transplanted organs – Identify causal factors that contribute to decisions of patients and families to contribute to kidney, liver, and pancreatic organ transplantation programs, particularly in minority communities. Develop novel strategies to enhance the availability of organs for transplant. Contact: Dr. Catherine Meyers, 301.451.4901, meyersc@mail.nih.gov.

02-OD(OSP)-101* Unique Ethical Issues Posed by Emerging Technologies. Advances in biotechnology and biomedical science raise novel ethical, legal, and social issues. Research in this area is needed to understand the unique ethical concerns related to emerging technologies (e.g. biotechnology, tissue engineering, nanomedicine, and synthetic biology). These include issues such as dual use research, privacy, safety, intellectual property, commercialization and conflict of interest, among others. Research is also needed to assess how these novel issues are addressed under current oversight and regulatory structures and identify where there may be gaps and/or need for revised or new oversight approaches. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NIDDK Contact: Dr. Olivier Blondel, 301-451-7334, blondelol@niddk.nih.gov.

02-OD(OSP)-102* Ethical Issues in Health Disparities and Access to Participation in Research. Research is needed to assess the under-representation in biomedical and clinical research of U.S. minority populations, underserved populations, and populations who may be vulnerable to coercion or undue influence, to identify barriers to participation in research and to develop approaches for overcoming them. Additionally, studies are needed to assess the impact and ethical considerations of conducting biomedical and clinical research internationally in resource-limited countries. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NIDDK Contact: Dr. Rebekah Rasooly, 301-594-6007, rasoolyr@EXTRA.NIDDK.NIH.GOV.

02-OD(OSP)-103* Ethical Issues Associated with Electronic Sharing of Health Information. The development of an electronic health information infrastructure and the sharing of health information for patient care and research offers enormous promise to improve health care and promote scientific advances. However, the broad sharing of such data raises numerous ethical issues that may benefit from additional studies (e.g. those related to privacy and confidentiality). Examples include studies to assess risks associated with health information technology and the broad sharing of health information for research, and novel approaches for mitigating them. Examination could also include analysis of current oversight paradigms and suggestions for enhancements, as well as assessments of how privacy risks may change in the future. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NIDDK Contact: Dr. Christine Hunter, 301-594-4728, hunterchristine@mail.nih.gov.

02-OD(OSP)-104* Ethical Issues in the Translation of Genetic Knowledge to Clinical Practice. Genetics and genomics have great promise for the development of personalized medicine, yet the ethical, legal and social implications of both the research and application of genetic and genomic knowledge and technology are far reaching. Studies are needed to better understand the factors that influence the translation of genetic information to improved human health and the associated ethical issues. Examples of studies include those to address ethical issues related to broad sharing and use of new genetic information and technologies for research to improve human health, human subjects protection in genetic and genomic research, the identifiability of genetic/genomic information and how our understanding of identifiability is evolving, return of research results and incidental findings to subjects, alternative models of informed consent for broad data sharing for research, and the impact of intellectual property (IP) issues on development of new technologies. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NIDDK Contact: Dr. Rebekah Rasooly, 301-594-6007, rasoolyr@EXTRA.NIDDK.NIH.GOV.

02-OD(OSP)-105* Ethical Issues Raised by the Blurring between Treatment and Research. The distinction between clinical practice and research is growing less clear, a trend that may be more pronounced with respect to genetic information and medical records research. Studies are needed to better understand the ethical issues associated with this trend. Examples of studies include those to identify how this blurring in roles affects traditional human subjects protections, including, for example, essential practices such as informed consent, conceptions of the doctor/patient and investigator/subject relationship, and privacy protections. OD(OSP) Contact: Abigail Rives, 301-594-1976, rivesa@od.nih.gov; NIDDK Contact: Dr. Rebekah Rasooly, 301-594-6007, rasoolyr@EXTRA.NIDDK.NIH.GOV.

(03) Biomarker Discovery and Validation

03-DK-101 Discovery of biomarkers for disease risk, progression or response to therapy in diseases of interest to NIDDK. A barrier to understanding and treating diseases of interest to NIDDK is the paucity of sensitive and validated biomarkers. Research is needed at all levels including identifying new targets, developing new imaging or non-invasive methods and validating promising biomarkers in well-characterized populations. Contact: Dr. Teresa Jones, 301-435-2996, jonester@mail.nih.gov

03-DK-102 Development and validation of novel, non-invasive methods to detect and monitor disorders of relevance to NIDDK at early stages of disease before major organ damage and dysfunction has occurred. Novel diagnostic methodologies relevant to disorders that are currently difficult to detect early in the course of disease and/or that require invasive procedures (such as tissue or organ biopsies) are of highest priority. Contact: Dr. Teresa Jones, 301-435-2996, jonester@mail.nih.gov

03-DK-103 Identify the normal and diseased proteome of subcellular organelles of relevance to NIDDK diseases. Studies are needed to identify ciliary or other organelle proteins in model organisms and human cells, using tissue from both healthy and diseased (Bardet-Biedel, PKD, nephronophthesis, etc.) sources. Contact: Dr. Teresa Jones, 301-435-2996, jonester@mail.nih.gov

03-DK-104 Development of drug toxicity biomarkers for kidney, liver, and other organs of NIDDK interest for use in assessing human drug toxicity. tudies are needed to identify markers of organ toxicity that can be used to screen potential therapeutic agents for diseases of relevance to NIDDK. Markers are also needed to identify organ specific damage in organs and tissues of interest to NIDDK. Contact: Dr. Teresa Jones, 301-435-2996, jonester@mail.nih.gov

03-DK-105 Nutrient biomarkers. Identification and validation of sensitive and predictive biomarkers are needed that evaluate status of a specific nutrient, that assesses biological effects that may be related to disease, and that may indicate individual response to nutrient-gene or nutrient-nutrient interactions. Such studies may be important for determining which diseases will respond to dietary interventions. Contact: Dr. Michael (Ken) May, 301-594-8884, maym@mail.nih.gov.

(04) Clinical Research

04-DK-101* Role of the human gut microbiome in NIDDK diseases. This effort would support metagenomic studies aimed at understanding the role of the human microbiome in contributing to NIDDK diseases and conditions. Studies are needed that would evaluate appropriate sampling techniques, high throughput platforms, and analytic techniques that would provide sufficient data to serve as the foundation for further hypothesis driven studies in the disease or condition of interest. Contact: Dr. Robert Karp, 301-451-8875, karpr@mail.nih.gov.

04-DK-102Develop improved techniques for clinical diagnosis, detailed clinical phenotyping, and clinical disease staging and activity for conditions of interest to NIDDK, including endocrine and metabolic diseases, digestive and liver diseases, renal and benign urologic and hematological diseases. Examples include developing a comprehensive disease profile, defining informative immunophenotypic profiles, and developing new technologies for anatomic and functional diagnosis. Contact: Dr. Myrlene Staten, 301.402.7886, statenm@mail.nih.gov.

04-DK-103Develop novel approaches to understand and treat functional disorders. Examples include characterizing the factors in diabetes that lead to the development of functional GI and motility diseases; Determine how genotype contributes to or predisposes patients to the development of functional GI and motility disorders; Determine the role of diet in the development of functional GI and motility disorders; Develop new technologies and therapeutic approaches to effectively treat patients with functional GI and motility disorders; Evaluate therapeutic outcomes and the impact of doctor/patient interactions to determine effective treatments for functional GI and motility disorders. Contact:Dr.Frank Hamilton, 301.594.8877, hamiltonf@mail.nih.gov.

04-DK-104Improve the diagnosis, staging and treatment of diseases of the liver. Examples include: viral hepatitis, non-alcoholic steatohepatitis, genetic diseases such as hemachromatosis and Wilson’s disease, inborn errors of metabolism, liver disease associated with cystic fibrosis, and biliary atresia, autoimmune liver diseases, and drug induced hepatotoxicity. Examples include devise novel diagnostic tests, biomarkers, imaging and other modalities to non invasively assess fibrosis and inflammation. Contact: Dr. Edward Doo, 301.451.4524, dooe@mail.nih.gov.

04-0DK-105Develop resources needed to support clinical research. Examples include assembling sample collections for uncommon conditions, developing centralized core reagents and assays for clinical research, and assembling clinical data for cross sectional epidemiological studies. Contact: Dr. Beena Akolkar, 301.594.8812, AKOLKARB@mail.nih.gov.

04-DK-106 Preservation/Recovery of endogenous insulin secretion: Insulin response to hyperglycemia in humans with type 2 diabetes diminishes with duration and severity of the disease but the mechanisms underlying this loss are only partly understood. Causes may include progressive loss of beta cell function due to the underlying disease or be a consequence of hyperglycemia and other metabolic derangements of diabetes. Failure of insulin response is at least partially reversible. New human pilot studies or ancillary studies within ongoing investigations are requested to explore the mechanisms of failure/recovery of insulin secretion. These could include strategies to reduce stress on endogenous insulin secretion to “rest” the beta cells or to reduce insulin resistance. New drugs, devices and therapeutic strategies provide opportunities for investigations that can pioneer new approaches to delaying onset or progression of type 2 diabetes. Contact: Dr. Peter Savage, 301-594-8858, savagep@mail.nih.gov.

04-DK-107 Understanding the mechanism by which bariatric surgery improves diabetes and cardiovascular risk factors. Resolution or amelioration of Type 2 diabetes after bariatric surgery has been observed both before and after substantial weight loss. Understanding the underlying mechanisms for this saluatory effect will help define optimal surgical approaches and identify new targets for therapy and prevention of diabetes and other obesity-associated co-morbidities. Contact: Dr. Myrlene Staten, 301-402-7886, statenm@mail.nih.gov

04-DK-108 Nutritional status of bariatric surgery patients. Studies to evaluate the nutritional status of bariatric surgery patients, including changes in blood/tissue levels of micronutrients or body stores of these nutrients before and after surgery. Also includes studies to determine the optimal nutrient supplementation needed in patients after different bariatric surgery procedures. Contact Dr. Carolyn Miles, 301-451-3759, milesc@mail.nih.gov.

04-DK-109 Optimal nutritional support in acute and chronic diseases/conditions. Includes studies to determine optimal macronutrient/energy composition, micronutrient supplementation, and delivery mode/timing of nutrition support formulas in patients with both acute and chronic nutrition support needs. Contact: Dr. Carolyn Miles, 301-451-3759, milesc@mail.nih.gov.

04-DK-110 Phenotyping eating and activity behaviors. Studies assessing methods for phenotyping eating or activity behaviors that can be used to inform behavioral genetic studies, including but not limited to methodologies to capture propensity for sedentary behaviors vs. vigorous activity, differing hedonic responses to high fat or high sugar foods, or differences in hunger and satiety. Contact: Dr. Susan Yanovski, 301-594-8882, yanovskis@mail.nih.gov.

04-DK-111 Pilot and feasibility clinical research studies in diabetes, obesity, and metabolic, endocrine, digestive, liver, renal and urological diseases. Translation of new research discoveries from preclinical phase to phase 3 randomized trials requires preliminary data on the safety, efficacy and feasibility of new interventions. Mechanistic studies may help explain response to therapy. In addition, new epidemiological research is required to estimate disease incidence, prevalence, and potential risk modifiers in the United States. These areas of investigation are required for the design of larger, long-term clinical trials and observational studies. Contact: Dr. Barbara Linder, 301-594-0021, linderb@mail.nih.gov.

04-DK-112 Comparative effectiveness research (CER) in diabetes, obesity, and metabolic, endocrine, digestive, liver, renal and urological diseases. Pilot feasibility studies and planning grants for CER that can be accomplished within two years are needed to plan long term multi center randomized controlled trials in diseases within the mission of NIDDK. Proposals must address a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Studies may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy. The analysis may focus only on the relative medical benefits and risks of each option, or it may also weigh both the costs and the benefits of those options. Examples include comparisons of multiple currently approved medical treatments and comparison of medical and surgical treatments for diabetes. Contact: Dr. Peter Savage, 301 594-8858, savagep@niddk.nih.gov.

(05) Comparative Effectiveness Research

05-DK-101* Selecting the Optimal Initial Treatment Regimen for Patients With Newly Discovered Type 2 Diabetes. The natural history of type 2 diabetes, treated by widely used current regimens, is marked by gradual increases in glucose levels, loss of insulin secretion, progressive increases in drug therapy, and frequent development of chronic complications. Clinical trial data suggests that aggressive early therapy attempting to keep glucose levels near normal is associated with a more benign long-term course. The optimal treatment regimen (effectiveness and avoidance of hypoglycemia) is not known, but current drugs provide options for multiple treatment approaches. In view of the numerous options, pilot studies are needed to assess the short-term effectiveness of common treatment strategies. Studies of treatments comparing different drugs and levels of glucose control or studies to use insulin sparing versus Insulin-intensive regimens will help to define the most effective short-term therapy. Impact of the approaches at one and two years can be assessed. These studies can measure effects on glucose control, hormone responses, adverse events, and cost of therapies, providing crucial data for designing future clinical trials to assess the long-term clinical effectiveness and cost of the most promising therapeutic approaches. Contact: Dr. Peter Savage, 301-594-8858, savagep@niddk.nih.gov

05-DK-102* Understanding the Effects of Bariatric Surgery on Type 2 Diabetes and Cardiovascular Risk Factors. Interest has been building in the scientific and medical communities regarding the risks and benefits of the different types of bariatric surgery in obese patients, with type 2 diabetes, particularly in those with lesser degrees of obesity. A randomized clinical trial to compare the impact of various types of bariatric surgery versus intensive medical weight loss treatment on type 2 diabetes is needed to understand the balance of risks and benefits of the different approaches. This is critically necessary given the increasing numbers of bariatric surgeries being performed and the lack of well-controlled studies to inform clinicians in selecting the best approach for a given patient and health care payors in their decision to cover specific procedures. Investigators could compare the impact of bariatric surgery compared with intensive medical weight loss treatment on insulin resistance, beta cell function, and resolution of type 2 diabetes in adults with type 2 diabetes and BMI between 30 and 40. Pilot and feasibility projects to explore different study designs and test feasibility of methods and implementation could be conducted using short term funding (~2 years). Evidence of feasibility in pilot studies would be expected to lead to a larger multi-site trial to determine long-term (3-5 year) impact of bariatric surgery on type 2 diabetes. Contact: Dr. Myrlene Staten, 301-402-78896, statenm@mail.nih.gov

05-DK-103* Antihypertensive Drugs and Level of Blood Pressure Control in Hemodialysis Patients.End-stage renal disease requiring dialysis is a burdensome, expensive medical and public health problem. Hypertension, present in nearly all dialysis patients, is a prime risk factor for cardiovascular disease (CVD) death and complications. Commonly used anti-hypertensive drugs including renin-angiotensin-aldosterone system (RAAS) inhibitors and non-RAAS agents (i.e., beta-blockers) improve survival in other populations, but it is not known whether a specific class of drug or level of blood pressure control can significantly reduce CVD morbidity and mortality in vulnerable hemodialysis patients. Projects that address these challenges could include planning or feasibility studies for a randomized trial of a representative subset of hemodialysis patients to better inform choices of anti-hypertensive therapy (RAAS vs. non-RAAS) and blood pressure targets. Short-term funding could be used for 1) meta-analysis of existing datasets or registries (for example, the United States Renal Data System), 2) planning grants for a randomized controlled trial, or 3) pilot studies of recruitment feasibility or implementation strategies. The NIDDK could fund a more definitive randomized clinical trial in subsequent years from its base. Contact: Dr. Catherine Meyers, 301-451-4901, meyersc@amil.nih.gov

05-DK-104* Fascial Versus Mid-Urethral Sling Surgery in Stress Urinary Incontinence Treatment Failures. Urinary incontinence affects 17-50% of all U.S. women, is increasing as the population ages, and is associated with diminished quality of life. Approximately 30% of women with urinary incontinence treated surgically undergo repeat procedures for recurrent stress urinary incontinence (SUI). Fascial sling surgery and mid-urethral sling surgery are used commonly in women with recurrent SUI who failed initial surgical treatment; however, it is not clear which strategy is better for improving continence, quality of life, and for reducing costs of health care. Short-term funds could be used for 1) planning grants for a RCT, or 2) pilot feasibility studies of recruitment or other implementation strategies. The NIDDK could fund a full randomized clinical trial in subsequent years from its base. Contact:  Dr. Robert Star, 301.594.7717.

05-DK-105* Medical Treatment of Calcium Stones: Calcium Stone Trial. Urolithiasis affects approximately 10 to 15 percent of the United States population, with a cost of at least $2.1 billion per year. The lifetime recurrence rate is 50 percent. After initial treatment, patients are commonly treated with potassium citrate or thiazide diuretics. However, the relative efficacy and durability of these two strategies has not been determined. Projects that address these challenges include planning or feasibility studies of a randomized trial of a representative sample of recurrent stone formers stratified by initial therapy, then randomized to receive potassium citrate or a thiazide diuretic to measure treatment durability, stone formation and passage, quality-of-life, and cost.Short-term funds could be used for 1) meta-analysis of existing datasets or registries (for example, Urologic Diseases in America), 2) planning grants for a randomized clinical trial, or 3) pilot studies of recruitment feasibility or implementation strategies. The NIDDK could fund a full randomized clinical trial in subsequent years from its base. Contact: Dr. Robert Star, 301-594-7717, changtd@mail.nih.gov and Dr. Paul Kimmel, 301-594-7713, kimmelp@mail.nih.gov.

(06) Enabling Technologies

06-DK-101* Development of cell-specific delivery systems for therapy and imaging. Develop non-viral strategies for cell-specific delivery of pathway-interactors and molecular probes. These new molecular complexes could allow delivery of cell-penetrating agents for the study of disease pathways, the imaging of tissue mass and disease progression, or the development of tissue-specific therapeutics. Contact: Dr. Olivier Blondel, 301-451-7334, blondelol@mail.nih.gov

06-DK-102* Mechanisms and measurement of human thermogenesis. The unique mechanisms that alter the efficiency of energy utilization in various organ beds—white and brown fat, skeletal muscle, liver, gut—remain largely unknown. New technologies are needed that can quantify organ specific energy production, utilization and heat production in human subjects. Contact: Dr. Maren Laughlin, 301-594-8802, laughlinm@mail.nih.gov.

06-DK-103 Enabling technologies in imaging: Bioimaging technologies and systems can greatly improve diagnosis and treatment in both pre-clinical and clinical areas that fall within the scope of NIDDK’s mission. Priority areas include, for example: Development of minimally invasive image-guided systems to improving biopsy sampling, safety of procedures, minimizing recovery time and complications of surgery; Development of bioimaging technologies and systems, especially those that enable robust, accurate and low cost point-of-care testingfor relevant biomarkers; Development of advanced clinical phenotyping techniques for early detection, diagnosis and response to treatment of diseases that are currently difficult to diagnose, detect or treat. For example, development of imaging methods for beta cell mass as an outcome for studies of diabetes therapy; nephron number, related to kidney function; organ fibrosis related to loss of liver, biliary, kidney or pancreas function; neuroimaging for appetite; and inflammation; and Enhancement of technologies for measuring the organ distribution of iron stores. Contact: Dr. Maren Laughlin, 301-594-8802, laughlinm@mail.nih.gov

06-DK-104 Enabling technology for the prevention and treatment of diseases within the NIDDK mission: Priority areas include, for example: Development of better tools for minimally invasive surgical procedures, such as urologic surgeries, to minimize complications and shorten recovery; Development of technologies to improve medication delivery capitalizing on new understandings of the molecular basis of relevant diseases that are robust, long lasting, and minimally toxic to neighboring cells; Improvement of medical devices such as catheters, dialysis equipment, and lithotriptors to minimize complications of procedures; Creation of new or improved mechanical designs and control algorithms for devices or surgical techniques aimed at normalizing urologic function, focusing on technologies for improving bladder control and function; and Develop novel informatic methods, techniques, algorithms or tools. Contact: Dr. Robert Star, 301.594.7717.

06-DK-105 Enabling technologies for cell biology and macromolecular analyses: Priority areas for disease within the NIDDK mission include: Development of “proteostasis” (protein homeostasis) monitoring tools and reagents to visualize critical processes such as protein aggregation,the protein folding capacity/competence of various subcellular compartments, the redox state of protein processing compartments, protein degradation capacity and the Unfolded Protein Response; Improvement of technologies for obtaining genomic, proteomic, and metabolomic data from individual viable cells in NIDDK-relevant tissue types; and Development of new tools and technologies to interrogate human mitochondrial function in vivo, includingmethods to manipulate human mitochondrial structure and activity, as well as novel imaging techniques to monitor and measure human mitochondrial function or dysfunction in healthy and diseased tissues. Contact: Dr. Christian Ketchum, 301.594.7717, ketchumc@mail.nih.gov

06-DK-106 Identifying a standard anthropometric measure for pediatric central adiposity. Identify reliable landmarks and methodology for pediatric abdominal circumference that correlate with total and intra-abdominal fat across the pediatric age, maturation, and total body adiposity range and are feasible in pediatric research studies in all settings, as well as clinical care. Such a measure could standardize phenotyping of pediatric research subjects and patients, and monitor response to intervention. Contact: Dr. Mary Horlick, 301-594-4726, horlickm@niddk.nih.gov.

06-DK-107 New technologies for nutrition research. Emerging technologies will be useful for further advances in studies of nutrient biomarkers, bioactive food components and strategies used for intervention efforts to reduce risk and complications of GI and liver disease. These include accelerator mass spectrometry, nanodevices, and new proteomics technologies. Further development of applications for nutrition research is needed. Contact: Dr. Michael (Ken) May, 301-594-8884, maym@mail.nih.gov.

(07) Enhancing Clinical Trials

07-DK-101 Enhancing clinical trials in diabetes, obesity, and metabolic, endocrine, digestive, liver, renal and urological diseases. Translation of new research developments from the laboratory into clinical practice requires the development of tools to facilitate the conduct of phase 3 clinical trials. This could include, but is not limited to, the development of 1) new statistical methodologies, including computer programs, to enhance data analysis and evaluate cost-effectiveness; 2) computer simulations to design trials and evaluate the implications of different designs; 3) predictive alogorithms or markers of disease development or progression, or response to therapy; 4) improved, non-invasive imaging tests; 5) instruments to assess behavior, adherence, processes of care and quality of life; and 6) registries or other infrastructure to enhance recruitment and retention of subjects. Proposals to develop resources should include a long-term plan for sustainability of the resource once funding has ended. Contact: Dr. Elizabeth Wright, 301.402.8729, wrightel@mail.nih.gov

07-DK-102 New and innovative technologies to monitor patient adherence in clinical trials of NIDDK interest: Develop and test new affordable, technologies to enable remote, centralized monitoring of physiologic and behavioral indices, as well as study medication adherence, and adverse effects in clinical trials. These technologies should provide opportunities to enhance efficiency in clinical trials. They should also be useful for future applicability to medical care in a non-trial setting, and may lead to enhanced chronic disease self-management. Contact: Dr. Marva Moxey-Mims, 301.594.7717, moxeymimsm@mail.nih.gov.

07-DK-103 Support for Registries: Develop an infrastructure for rare disease registries in areas of NIDDK mission, showing the feasibility of populating such a registry, and developing a long-term plan for sustainability of the registry beyond the 2 year funding period. Establishment of comprehensive registries with well-characterized patients, that may include samples of urine, serum, biopsy / surgical tissue, radiographs. Contact: Dr. Marva Moxey-Mims, 301.594.7717, moxeymimsm@mail.nih.gov.

07-DK-104 Assessing cost effectiveness of discrete interventions in clinical trials of diseases in NIDDK mission. Develop methods for incorporating data regarding health care utilization of enrolled subjects into study data sets such that analyses of cost effectiveness of interventions can be undertaken. Such an approach can be undertaken in existing multi center trials by incorporating new projects that would rigorously collect all healthcare utilization data on enrolled participants.Contact: Dr. Marva Moxey-Mims, 301.594.7717, moxeymimsm@mail.nih.gov.

07-DK-105Develop innovative technology for the diagnosis and treatment of diseases of NIDDK interest, including luminal disease of the alimentary system. Examples include: Develop and validate a method to perform “molecular” biopsy of luminal abnormalities in real time; Develop improved instrumentation for therapeutic endoscopy; Develop improved virtual endoscopy technology to access the luminal space of the GI tract; Develop new PET tracers for clinical use, including markers of proliferation, tumor-specific antigens, and markers of apoptosis and inflammation; Develop intraoperative high-energy gamma and beta detectors to enhance intraoperative localization; Develop energy delivery and real-time tracking devices to optimize local image-guided interventions; Develop improved devices for facilitating single port laparoscopic procedures, intraluminal procedures, natural orifice surgeries, and robotically assisted procedures. Contact: Dr. Frank Hamilton, 301.594.8877, hamiltonf@mail.nih.gov

(08) Genomics

08-DK-101 Develop an individualized approach to risk evaluation and management based on genetic susceptibility in diseases of interest to NIDDK. Examples include: Complete identification of risk susceptibility genes among diverse patient populations; Determine the functional role of NIDDK disease-associated gene variants in pathophysiologic pathways leading to NIDDK diseases; Determine the impact of environmental factors on disease-associated genetic variants; Define genetic subset/phenotype-genotype correlations, Identify and assess relevant pharmacogenetic variations; Correlate genotype (disease susceptibility and pharmacogenetics) with response to therapy and incorporate genotypes into clinical trials; Use genotypic variations to define disease risk. Contact: Dr. Rebekah Rasooly, 301-594-6007, rasoolyr@mail.nih.gov

08-DK-102 Beyond GWAS. Use methods such as ‘deep’ sequencing, exon sequencing, high-throughput genotyping and comparative genome hybridization to identify structural variations to pinpoint causal variants associated with NIDDK-relevant diseases or phenotypes, especially those identified in GWAS. Contact: Dr. Rebekah Rasooly, 301-594-6007, rasoolyr@mail.nih.gov

08-DK-103 Genetic interactions for complex diseases. Develop and apply new approaches to study gene-gene and gene-environment interactions and epigenetic processes affecting the development of NIDDK-relevant diseases or phenotypes, especially using genes identified through GWAS. Contact: Dr. Paul Kimmel, 301.594.7713, kimmelp@mail.nih.gov.

08-DK-104 Genome wide genetic studies. Carry out genome-wide studies of understudied diseases and phenotypes within the NIDDK mission, especially in minority populations, to identify associated loci and genes. Contact: Dr. Catherine McKeon, 301-594-8810, mckeonc@mail.nih.gov

08-DK-105 Modifier loci – use genetic and genomic technologies to identify modifier loci, genes and specific variants influencing the phenotype of Mendelian diseases within the NIDDK portfolio. Contact: Dr. Catherine McKeon, 301-594-8810, mckeonc@mail.nih.gov

08-DK-106 Genomics of complex diseases – Develop and use new methods to integrate data such as pathway analysis, gene interactions and expression data to better understand the pathophysiology of complex diseases, such as obesity, diabetes, Inflammatory Bowel Disease (IBD), and diabetic complications. Contact: Dr. Robert Karp, 301-451-8875, karpr@mail.nih.gov

08-DK-107 Nuclear Receptor mediated assembly of functional transcriptional units. Recent studies have revealed that Nuclear Receptors, particularly in response to ligands, seed the formation of transcriptional complexes both at proximal promoters and distal enhancers. Recruitment of coregulators with enzyme activities essential to cofactor exchange, chromatin remodeling, transcriptional activation, and RNA processing follows may be mimicked by agonists and small molecule compounds with drug-like activities. The application of genome-wide analyses of response element occupancy has the potential to rapidly and comprehensively reveal novel mechanisms of gene regulation. When applied to models of disease, including mouse models of diabetes and obesity, and human tissue samples, new insights into mechanisms of disease will be obtained. Contact: Dr. Ronald Margolis, 301-594-8819, margolisr@mail.nih.gov

08-DK-108 Bioactive food components. Identification and characterization of sites of action of specific bioactive food components, as well as interactions of bioactive components, will be important in understanding how such sites relate to disease intervention. Further work is needed at the genetic, epigenetic and post-translational levels, all of which have now been shown to be affected by a number of bioactive food components. Contact: Dr. Michael (Ken) May, 301-594-8884, maym@mail.nih.gov.

08-DK-109 Characterization of polymorphisms associated with nutrition. Single polynuclear polymorphisms (SNP) are now recognized as factors which can affect responses to specific nutrients at sites of action, absorption, and metabolism. Such have already been identified for vitamin D, folate and amino acid metabolism. Further work on identification and characterization of SNP-nutrient responses should explain individual variations in nutrient status and responses to dietary treatments. Contact: Dr. Michael (Ken) May, 301-594-8884, maym@mail.nih.gov.

(09) Health Disparities

09-DK-101 Identifying factors that influence health disparities in NIDDK Diseases. Clearly, health disparities in the United States are related to a complex set of issues that includes social and economic factors. Access to care is a particularly strong predictor but, even when access is adequate, health disparities often remain. The reason for continued disparities within healthcare systems is not well understood and may be related to healthcare practices, system or provider level biases, environmental factors, patient level factors such as age, gender, genetics, cultural beliefs, trust, and behavioral norms, or an interaction between these various factors. Exploratory research is sought to identify factors, other than access to care, that influence and can potentially mitigate health disparities in NIDDK diseases. Contact: Dr. Peter Savage, 301 594-8858, savagep@niddk.nih.gov

09-DK-102Identifying causes of health disparities in patients with NIDDK diseases. The prevalence and both acute and chronic complications of diabetes (type 1 and 2) are higher and life expectancy is generally lower in U.S. minority patients with diabetes. The prevalence of chronic kidney disease does not vary greatly by demographics (race and gender); however, progression (as measured by end stage renal disease) is much greater for minorities and for males. Access to transplantation differs greatly by race despite a national system to promote equal access; African Americans also have poorer long term renal allograft survival. Minorities have a higher incidence of certain glomerular disease (FSGS, lupus nephritis), and of arteriovenous access failure. Additional studies to understand basis of these differences are needed to help to identify focused interventions targeted to the vulnerability of a group. Examples include: identify factors responsible for differences in incidence, complication rates, or response to treatment regimens between in subgroups of the U.S. population; and development of methods to remove barriers and improve outcomes. Studies might be performed in small populations with unique characteristics, or using existing data or samples from clinical trials and epidemiologic studies. Contact: Dr. Peter Savage, 301 594-8858, savagep@niddk.nih.gov.

09-DK-103 Evaluating the efficacy of educational outreach to under-served communities. Many NIDDK relevant diseases disproportionately affect minority populations. Develop and evaluate improved effective educational materials and outreach approaches to these communities. Contact: Dr. Andrew Narva, 301.594.8864, narvaa@mail.nih.gov.

(10) Information Technology for Processing Health Care Data for Research

10-DK-101   Virtual biosample/data catalogue. Develop information technology to create a virtual biosample/data cataologue of available biosamples/data contained in the NIDDK repository or other large collections relevant to NIDDK research. By collecting inventory data using standardized language and descriptors, with common variables, researchers will be able to search across many different repositories to find biosamples of interest. Contact: Dr. Paul Eggers, 301 594-8305, eggersp@extra.niddk.nih.gov.

10-DK-102   Accessing CMS part D (pharmaceutical data) for drug comparative effectiveness research studies in areas of NIDDK mission. Contact: Dr. Paul Eggers, 301 594-8305, eggersp@extra.niddk.nih.gov.

10-DK-103   Use of NIDDK repository data or USRDS/UDA data for outcome studies in NIDDK disease areas. Contact: Dr. Paul Eggers, 301 594-8305, eggersp@extra.niddk.nih.gov

(11) Regenerative Medicine

11-DK-101 Promote regeneration and repair in the digestive system, liver, pancreas, kidneys, Hematologic, and urological system. Develop the knowledge base or research tools to understand normal repair processes and their alteration during disease or infection; define the molecular pathways that regulate the integration of different cell types into a functional tissue; or facilitate engineering of functional tissues or artificial organs in vitro for transplantation or to foster tissue regeneration directly in vivo. May study tissues from humans, experimental animals, or model systems. Contact: Dr. Deborah Hoshizaki, 301-594-7712, hoshizakid@mail.nih.gov

11-DK-102 Vascular network in engineered or regenerated tissues. Research on the design, optimization, and formation of a complete vascular network capable of delivering oxygen and nutrients and removing waste products in NIDDK relevant engineered or regenerated tissues. Contact: Dr. Deborah Hoshizaki, 301-594-7712, hoshizakid@mail.nih.gov

11-DK-103 Organ innervation. Develop a basic cellular, molecular, and genetic understanding of the biology of organ innervation during development, disease progression, repair following injury, and engraftment of transplanted organs. Examples include: the developmental mechanisms underlying neural crest fate specification and migration to NIDDK relevant organs as well as factors that guide these processes and regulate neural survival; mechanisms of neural repair and autonomic plasticity to restore innervation of -NIDDK relevant organs in the aftermath of organ disease, injury, or transplantation. Contact: Dr. Deborah Hoshizaki, 301-594-7712, hoshizakid@mail.nih.gov

11-DK-104 Use of Hematopoietic Stem Cells (HSC) to regenerate or repair mesenchymal tissues. Examples include: Develop and validate methods and reagents that induce HSCs to develop or trans-differentiate into different mesenchymal cell and tissue types; Develop and validate methods and reagents that allow HSCs to be propagated in vitro without loss of self-renewal potential. Contact: Dr. Terry Bishop, 301.594.7726, bishopt@mail.nih.gov

11-DK-105 Transdifferentiation or directed reprogramming of one cell fate to another (e.g., a pancreatic exocrine cell to a pancreatic beta cell). Recent evidence has demonstrated that is possible to directly reprogram a fully committed differentiated cell from one lineage into another, thereby bypassing steps of either de-differentiation or reversion to a pluripotent state. Examples include: Identify and use of small molecules rather than viral reprogramming inducers to achieve direct reprogramming; Explore strategies for the in vivo programming of cell fates. Contact: Dr. Sheryl Sato, 301-594-8811, smsato@mail.nih.gov

11-DK-106 Enhancing beta cell replication or beta cell mass. There is emerging evidence in rodents and humans that pancreatic beta cells may have significant regenerative potential, but that this potential is dampened by ongoing autoimmune attack in type 1 diabetes and by the loss and dysfunction of beta cells in type 2 diabetes. Examples include: Identify small molecules and factors that promote expansion of beta cell mass; Determine the regenerative capacity of human islets in a variety of pathophysiological settings (hyperglycemia, inflammation, etc.). Contact: Dr. Sheryl Sato, 301-594-8811, smsato@mail.nih.gov

11-DK-107 Directed replication and differentiation of replacement cells from adult stem cells in situ. Research to identify key endogenous or exogenous factors that can be used to direct digestive system stem cell replication and daughter cell differentiation in situ in order to speed healing under conditions of tissue damage and disease. Contact: Dr. Jill Carrington, 301-402-0671, carringj@mail.nih.gov

(12) Science, Technology, Engineering and Mathematics (STEM) Education

12-DK-101 Increasing involvement of surgical sub-specialties in biomedical research. The surgical sub-specialist is under-represented in the NIDDK research portfolio, however; it is vitally important to increase their participation in basic and clinical research to better translate research developments into improved surgical and clinical practice. Responsive research topics in areas of NIDDK research mission include: identifying causal factors that preclude surgeons from a career in research; piloting interventions that facilitate research participation of surgeons. Contact: Dr. Robert Star, 301.594.7717.

12-DK-102 Expanding Biomedical Research Opportunities at the Undergraduate Level. Undergraduate college students are provided little opportunity to experience biomedical laboratory research in a mentored environment. It is important to increase the participation of college students, especially those who have not yet made biomedical career decisions, in laboratories conducting biomedical research and to develop effective mentoring programs. Contact: Dr. Tracy Rankin,301.594.4748, rankint@mail.nih.gov.

12-DK-103 Evaluating the efficacy of mentoring training in STEM fields. Effective mentoring early in the biomedical career path is important to maintaining interested individuals in biomedical careers. Research that evaluates and designs effective programs to “mentor the mentor” in areas of NIDDK research mission will be responsive. Contact: Dr. Tracy Rankin,301.594.4748, rankint@mail.nih.gov.

12-DK-104 Increasing participation of mathematicians, engineers and computational specialists in biomedical research. Today’s research environment demands the involvement of inter-disciplinary teams to further the translation of basic science advances into improved public health. Responsive research topics in areas of NIDDK research mission include: evaluating the efficacy of current STEM curricula and training programs to attract these specialists to biomedical research.Contact: Dr. Tracy Rankin,301.594.4748, rankint@mail.nih.gov.

(13) Smart Biomaterials - Theranostics

13-DK-101 Theranostics. Examples: Development of novel approaches and technologies relevant to the NIDDK mission including agents with combined diagnostic/therapeutics properties or drug-biomarker combinations useful in Phase 0 studies. These might allow for a more precise diagnosis, assessment of the effectiveness of therapeutic interventions, prediction of individual susceptibility/responsiveness to therapeutic intervention, and optimized personalized therapeutic strategies. Contact: Dr. Guillermo Arreaza, 301-594-4724, arreazag@mail.nih.gov.

13-DK-102 Glucose sensing and insulin delivery devices. Application of nanotechnology and microfabrication advances combined with smart biomaterials to the design of new glucose sensing and insulin delivery devices/platforms. Contact: Dr. Guillermo Arreaza, 301-594-4724, arreazag@mail.nih.gov.

13-DK-103 Scaffolds, biomatrices, smart materials. Examples: Development of novel biomaterials, scaffolds, and biomatrices that may modulate cellular behavior, differentiation, and engraftment to optimize cellular replacement therapies and tissue engineering; Development of smart biomaterials, implantable biohybrids matrices or membranes that may release bioactive agents that promote vascularization, innervation, or inhibit the inflammatory/fibrotic response thus improving biocompatibility and durability. Contact: Dr. Guillermo Arreaza, 301-594-4724, arreazag@mail.nih.gov.

13-DK-104 Islet encapsulation. Development of novel islet encapsulation technologies/biomaterials for the optimization of a bioartificial pancreas. Contact: Dr. Guillermo Arreaza, 301-594-4724, arreazag@mail.nih.gov.

(14) Stem Cells

14-DK-101* Induced pluripotent stem cells--cellular and humanized mouse models of disease. Somatic cells, such as fibroblasts, from patients with diseases can be used to create cell lines, tissues and, perhaps, organ systems, through induced Pluripotent Stem Cell (iPSC) technology. Such models could be used to elucidate underlying pathology of disease or screen for agents that could be used therapeutically. Combining this approach with mouse strains able to accept multiple human tissues without rejection could provide the microenvironmental milieu to support the tissue’s physiological function within the context of the whole organism, enabling greater understanding of disease pathogenesis and providing a platform for preclinical testing of drug candidates. Contact: Dr. Dan Wright, 301-594-7717, wrightdan@mail.nih.gov


14-DK-102 Discovery of methods to program stem or progenitor cells.
These methods would allow manipulation of stem or progenitor cells in a predictable manner to differentiate into cells/tissues of NIDDK relevance; such as, hematopoietic cells, bladder, liver, intestine, pancreas, kidney, prostate, etc. Studies may rely upon model organisms with a goal of application to humans. Contact: Dr. Sheryl Sato, 301-594-8811, smsato@mail.nih.gov.

14-DK-103 Generation of stem cells from patients with NIDDK-relevant genetic diseases. Stem cells from patients (either derived directly or reprogrammed into induced pluripotent stem cells (iPS)/progenitor cells) can be used to explore disease processes as they develop from stem, progenitor or iPS cells. This model cell system can then be used from patients to test therapeutics. Contact: Dr. Dan Wright, 301-594-7717, wrightdan@mail.nih.gov.

14-DK-104 In vitro differentiation of human Embryonic Stem Cells (ES)/Induced Pluripotent Stem Cells (iPS) to NIDDK relevant cells/tissues. Strategies could be developed to direct the differentiation of pluripotent stem cells toward a desired cell fate. The identification of small molecules/growth factors that could carry out this process efficiently would enable the generation of novel cellular replacement therapies for NIDDK relevant diseases. Contact: Dr. Sheryl Sato, 301-594-8811, smsato@mail.nih.gov.

(15) Translational Science

15-DK-101* Identification of bioactive macronutrients in the diet that impact metabolic state. Recent studies suggest that specific types of macronutrients in the diet, such as resistant starch or branched chain amino acids, may have selective effects on nutrient absorption, insulin sensitivity, and lipid metabolism. Elucidation of the metabolic impact of specific dietary components may well result in improved efficacy of lifestyle approaches to reduce obesity and metabolic diseases. Pilot studies are encouraged to identify specific bioactive components in the diet and study their mechanisms of action. Contact: Dr. Sue Yanovski, 301.594.8882, yanovskis@mail.nih.gov.

15-DK-102 Develop improved animal models of NIDDK diseases. Many NIDDK diseases lack appropriate experimental models that mimic human disease. Examples: Development of relevant models in mammalian or model organisms (for example, zebrafish); Introduction of human or human orthologous mutations; cross-species comparisons to elucidate underlying molecular and related metabolic functions; and Development of parallel strains for complementation/mutational analysis. These models would greatly facilitate opportunities for identifying targets for intervention and new therapeutic strategies. Contact: Dr. Kristin Abraham, 301.496.2422, abrahamk@mail.nih.gov.

15-DK-103 Translate discovery of new molecules and pathways in pathogenesis of NIDDK diseases into potential therapies, diagnostics, or research tools. Examples include: Improve pharmacokinetics, toxicity, or bioavailability of potential leads identified by high throughput screens; Develop assays to screen novel targets with small molecules; and validate novel molecules as therapeutic targets for disease. Contact: Dr. Myrlene Staten, 301.402.7886, statenm@mail.nih.gov.

15-DK-104 Develop probiotic systems for delivery of drugs or micronutrients or degradation of deleterious compounds. Examples: modify gut bacteria to deliver small molecule drugs, vitamins such as vitamin D, or metabolize harmful compounds such as environmental toxins or trans fats to prevent or treat NIDDK diseases. Contact: Dr. Robert Karp, 301.451.8875, karpr@mail.nih.gov.

15-DK-105 Comparing prostate morphology and symptom profiles. The relationships between prostate structure and disease course for treated and untreated benign prostatic hyperplasia (BPH) remain to be fully determined. An assessment of histopathological changes in the prostate relative to changes in evolving symptom profiles for clincal BPH (i.e., BPH with accompanying lower urinary tract symptoms (LUTS)) is needed to inform on disease etiology; aid in the clinical prediction of progression; and may facilitate development of preventative or therapeutic strategies. Contact: Dr. Chris Mullins, 301.451.4902, mullinsc@mail.nih.gov

15-DK-106 Translating basic hematology concepts. Recent fundamental discoveries have improved our understanding of nonmalignant hematologic processes including heme regulation during erythropoiesis, ribosomal dysfunction in hematologic diseases, iron overload, and the role of erythopoietin receptor in non-hematopoietic cells. Efforts to develop translational tools including improved animal models, biomarkers, and imaging methods will improve our ability to prevent and treat nonmalignant hematologic diseases. Contact: Dr. Terry Bishop, 301.594.7726, bishopt@mail.nih.gov

15-DK-107 Infectious etiologies for urologic chronic pain conditions. Chronic urologic pelvic pain syndromes Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) have been hypothesized to have an infectious etiology. However, the potential contribution of non-traditional pathogens or changes in the normal flora to these conditions has not been sufficiently addressed. Efforts using new and novel methods are needed to assess the microbiological profile of patients. Resulting insights would have an immediate impact on developing anti-viral or anti-bacterial treatment strategies. Contact: Dr. Chris Mullins, 301.451.4902, mullinsc@mail.nih.gov

15-DK-108 Gene expression in GU tract development and GU disease. Catalog expression of genes and proteins during GU tract development in humans, focusing on pathological tissues derived from patients with GU congenital malformations and GU diseases. Contact: Dr. Deborah Hoshizaki, 301.594.7712, hoshizakid@mail.nih.gov.

15-DK-109 Lymphatics research in the digestive system. Research to identify changes to lymphatics in the digestive system under conditions of inflammation and disease, develop animal models that recapitulate these changes, and develop methods to mitigate these changes in order to alleviate lymphatics-related disease symptoms and progression. Examples of possible lymphatics-associated changes include altered fluid transport and edema, altered nutrient absorption and transport, and altered hormone transport. Contact: Dr. Jill Carrington, 301-402-0671, carringj@mail.nih.gov

15-DK-110 Organ smooth muscle function in disease. Research to understand smooth muscle dysfunction in the digestive and urinary systems. Examples include: isolation and characterization of stem or progenitor cells that contribute to smooth muscle growth after damage or to treat short bowel syndrome; research on the impact of altered smooth muscle physiology on motility disorders and sphincter dysfunction; research on the contribution of smooth muscle to inflammatory conditions; research to understand the interactions of smooth muscle with associated nerve or interstitial cells of Cajal. Contact: Dr. Jill Carrington, 301-402-0671, carringj@mail.nih.gov

15-DK-111 The role of gastrointestinal surgical procedures in amelioration of type 2 diabetes. Resolution or amelioration of Type 2 diabetes after bariatric surgery has been observed both before and after substantial weight loss. Understanding this saluatory effect in animals will help define optimal surgical approaches and identify new targets for therapy and prevention of diabetes. Mechanistic studies of the differential effects of various gastrointestinal surgical procedures may define how altered gut function and physiology impact glucose homeostasis. Contact: Dr. Myrlene Staten, 301-402-7886, statenm@mail.nih.gov.

For general information on NIDDK’s implementation of NIH Challenge Grants, contact:

Dr. Brent Stanfield
Director, Division of Extramural Activities
NIDDK
National Institutes of Health
Phone: 301.594.8843
Email: stanfibr@mail.nih.gov

For Financial or Grants Management questions, contact:

Ms. Dee Doherty
Deputy Grants Management Officer
NIDDK
National Institutes of Health
Phone: 301.594.8838
Email: dohertyd@mail.nih.gov

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Page last updated: March 06, 2009

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