The National Institute of Diabetes & Digestive & Kidney Diseases

Digestive Diseases Databases, Registries and Information

Acute Liver Failure Study Group (ALFSG)

The ALFSG is collecting biosamples and information on the natural history, causes and outcomes of Acute Liver Failure (ALF) in the United States. In addition to the database, a clinical trial was conducted to test whether the drug N-acetylcysteine improves outcome (survival) for patients with ALF not caused by acetaminophen overdose has recently been published. Results can be found at:http://www.ncbi.nlm.nih.gov/pubmed/19524577?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract  Additional information can be obtained at: www8.utsouthwestern.edu/utsw/cda/dept25203/files/89624.html 

For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

Adolescent Bariatrics: Assessing Health Benefits and Risks (Teen-LABS)

The Teen-LABS consortium is made up of five clinical centers and a data coordinating center. The goal of Teen-LABS is to facilitate coordinated clinical, epidemiological, and behavioral research in the field of adolescent bariatric surgery, through an observational study protocol for uniform data collection pre-operative, at surgery, and through 2 years post-operative at participating centers performing bariatric surgery on teenagers.  The use of standardized definitions and data-collection instruments for sequential patients scheduled for surgery at each site will yield meaningful evidence-based recommendations for patient evaluation, selection, and follow-up care. In addition to investigating surgical outcomes, another broader goal of Teen-LABS is to better understand the etiology, pathophysiology, and behavioral aspects of severe obesity in youth and how this condition affects human beings over time. Additional information can be found at: www.cincinnatichildrens.org/research/project/teen-labs/

For more information, contact Dr. Mary Horlick, DDN, Director, Pediatric Clinical Obesity Program.

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The Clinical Outcomes Research Initiative, CORI, provides gastrointestinal physicians, nurses and researchers with software, research data and tailor-made services aimed to advance the overall practice of endoscopy.

For more information, contact Dr. Jay Everhart, DDN, Director, Epidemiology and Data Systems Branch.

A collection of statistics about specific digestive diseases, including prevalence, mortality, care delivery and cost.

Drug-Induced Liver Injury Network (DILIN)

Both a prospective and retrospective database containing cases of drug-induced liver disease, DILIN is funded by a cooperative agreement and includes five clinical centers and a central data coordinating center. One of the goals of DILIN is to establish a database of well-characterized cases of drug-induced liver injury along with serum, DNA, and tissue samples that will facilitate research on the mechanisms of hepatic injury due to drugs. Cases of liver injury due to herbal medications are also included. DILIN will develop standardized definitions of drug-induced liver disease and standardization of scoring systems for causality. Additional information can be obtained at: https://dilin.dcri.duke.edu

For more information, contact Dr. Jose Serrano, DDN, Director, Liver and Biliary Program and Pancreas Program.

Hepatitis B Research Network (HBRN)

The Hepatitis B Research Network (HBRN) brings together clinical centers with expertise in caring for patients with chronic hepatitis B virus (HBV) infection. An estimated 2 billion people worldwide have been infected with HBV and about 400 million persons are living with chronic HBV infection. Of those with childhood-acquired chronic HBV infection, it is estimated that 25% will later succumb to liver-related complications of cancer and cirrhosis if left untreated. The prevalence of HBV infection is uneven throughout the world, with significant burdens in Asia and the Pacific Islands, sub-Saharan Africa, the Amazon Basin, and Eastern Europe. The goal of the Network is to conduct research on chronic hepatitis B, in order to better understand the physiological effects of the disease and develop effective treatment strategies with the currently available therapies. Additional information can be obtained at: www.hepbnet.org 

For more information, contact Dr. Edward Doo, DDN, Director, Liver Diseases Program.

Inflammatory Bowel Disease Genetic Consortium (IBDGC)

The NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC) consists of investigators from seven sites in the U.S. and Canada, who have recruited a large sample of inflammatory bowel disease patients, their relatives, and control subjects. All of the individuals in this sample have been evaluated according to a standardized protocol for clinical traits related to IBD, and have donated blood samples as a source of DNA. The IBDGC investigators are conducting genetic linkage and association studies to identify genes influencing predisposition to IBD. Additional information can be obtained at: http://info.med.yale.edu/intmed/ibdgc/index.html 

The Centers are housed at outstanding academic institutions, staffed by experts in state-of-the-art technology. Researchers can ship mice to one of the four Centers and obtain on a fee-for-service basis a range of complex exams used to characterize mouse metabolism, blood composition including hormones, energy balance, eating and exercise, organ function and morphology, physiology and histology. Many tests are done in living animals and are designed to elucidate subtle to complex traits that would define models of metabolic disease.

For more information, contact Dr. Maren Laughlin, DEM, Senior Advisor for Integrative Metabolism.

The digestive diseases clearinghouse provides comprehensive information about digestive health and disease for the public: online, in booklets and fact sheets, by email, and over the phone.

For more information, contact Ms. Kathy Kranzfelder, OCPL, Director, NIDDK Information Clearinghouses.

The National Gene Vector Laboratories (NGVL) are composed of an interactive group of academic production and pharm/tox laboratories whose primary goal is to provide eligible investigators with clinical grade vectors for phase I/II gene therapy clinical trials and to provide support for relevant pharmacology/toxicology studies leading up to clinical gene transfer protocols. If the application is approved, clinical grade material will be produced at no cost to the investigator.

For more information, contact Dr. Catherine McKeon, DEM, Senior Advisor for Genetic Research in Diabetes, Endocrinology and Metabolic Diseases.

The Nuclear Receptor Resource (NRR) Project is a collection of individual databases on members of the steroid and thyroid hormone receptor superfamily. Although the databases are located on different servers and are managed individually, they each form a node of the NRR. The NRR itself integrates the separate databases and allows an interactive forum for the dissemination of information about the superfamily.

For more information, contact Dr. Ronald Margolis, DEM, Senior Advisor, Molecular Endocrinology.

Commensurate with this directive, NURSA's goals can be distilled into two broad aims: (i) to execute research strategies designed to rapidly and efficiently elucidate those facets of orphan nuclear receptor biology we deem most critical to its understanding; and (ii) to facilitate the generation of hypotheses, design of experiments and communication of results by scientists active in this field. We anticipate that this initiative will provide a valuable service to the nuclear receptor community by developing a web-accessible bioinformatics resource, in which current and emerging data will be organized into more accessible and "user-mineable" forms.

For more information, contact Dr. Ronald Margolis, DEM, Senior Advisor, Molecular Endocrinology.

The U.S. Organ Procurement and Transplantation Network (OPTN) maintains a registry of human tissues in order to ensure the success and efficiency of the U.S. organ transplant system.

For more information, contact Dr. Thomas Eggerman, DEM, Director, Islet Transplantation Clinical Trials Program.

Pediatric Acute Liver Failure (PALF) Study 

This multi-center, multi-national collaborative group of pediatric clinical liver centers is aimed at identifying, characterizing, and developing management strategies for infants, children, and adolescents who present with acute liver failure (ALF). In addition to a database of pediatric patients with ALF, a clinical trial is being conducted to test whether the drug N-acetylcysteine (NAC) improves outcome (survival) for patients with ALF not caused by acetaminophen overdose. Additional information can be obtained at: www.palfstudy.org

For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

Digestive Diseases Multicenter Clinical Research

Action for Health in Diabetes (Look AHEAD)

This study is a 16-center, randomized clinical trial investigating the long-term health consequences of weight loss. The Look AHEAD cohort comprises approximately 5,000 overweight or obese participants with type 2 diabetes, aged 45-76. Participants were randomized to one of two interventions: an intensive lifestyle intervention designed to produce and sustain weight loss over the long term or a diabetes support and education arm. Participants will be followed for a total of 11 to 13.5 years from randomization. Additional information can be obtained at: www.lookaheadtrial.org     

For more information, contact Dr. Mary Evans, DDN, Director, Special Projects in Nutrition, Obesity, and Digestive Diseases.

Acute Liver Failure Study Group (ALFSG)

The ALFSG is collecting biosamples and information on the natural history, causes and outcomes of Acute Liver Failure (ALF) in the United States. In addition to the database, a clinical trial was conducted to test whether the drug N-acetylcysteine improves outcome (survival) for patients with ALF not caused by acetaminophen overdose has recently been published. Results can be found at:http://www.ncbi.nlm.nih.gov/pubmed/19524577?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract Additional information can be obtained at: www8.utsouthwestern.edu/utsw/cda/dept25203/files/89624.html

For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL)

This study supports nine liver transplant centers with expertise in adult living-donor liver transplantation (LDLT) and a central data coordinating center. The major aims of A2ALL are as follows:

• Quantify the impact of choosing LDLT on the candidate for transplantation
• Characterize the difference between LDLT and deceased donor liver transplant (DDLT) in terms of post-transplant outcomes, including patient and graft survival, surgical morbidity, and resource utilization on the recipient of a transplant
• Determine the short- and long-term health and quality of life (QOL) impact of donation, including (a) morbidity after liver donation and (b) long-term health-related QOL of donors.
• Standardize and assess the role of "informed consent" in affecting the decision to donate and satisfaction after living liver donation
• Other aims include comparison of the severity of recurrence of hepatocellular carcinoma for DDLT versus LDLT, the systematic characterization of liver regeneration and function in donors and recipients, the evaluation of the differences in the immune response to LDLT versus DDLT, and the establishment of a robust data and sample repository on liver transplantation that may be used to study clinical and biological questions as new technologies and resources become available. Patients enrolled in the study will be followed and managed in a standardized fashion. Additional information can be obtained at: www.nih-a2all.org
• For more information, contact Dr. Jay Everhart, DDN, Director, Epidemiology and Data Systems Branch.

Childhood Liver Disease Research and Education Network (ChiLDREN)

The overall goal of ChiLDREN is to establish a database of clinical information and serum and tissue samples from children across the United States and Canada with Biliary Atresia, Idiopathic Neonatal Hepatitis, Cystic Fibrosis Liver Disease, Alagille Syndrome, Alpha-1 Antitrypsin Deficiency, Bile Acid Synthesis Defects, Mitochondrial Hepatopathies, and Progressive Familial Intrahepatic Cholestasis in order to facilitate research and to perform clinical, epidemiological, and therapeutic trials in these important pediatric liver diseases. Three NIDDK-funded consortia, Biliary Atresia Research Consortium (BARC), Cholestatic Liver Disease Consortium (CLiC), and the Cystic Fibrosis Liver Disease (CFLD) Network were consolidated to form ChiLDREN. Additional information can be obtained at: www.childrennetwork.org

For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

The Clinical Outcomes Research Initiative, CORI, provides gastrointestinal physicians, nurses and researchers with software, research data and tailor-made services aimed to advance the overall practice of endoscopy.

For more information, contact Dr. Jay Everhart, DDN, Director, Epidemiology and Data Systems Branch.

Drug-Induced Liver Injury Network (DILIN)

Both a prospective and retrospective database containing cases of drug-induced liver disease, DILIN is funded by a cooperative agreement and includes five clinical centers and a central data coordinating center. One of the goals of DILIN is to establish a database of well-characterized cases of drug-induced liver injury along with serum, DNA, and tissue samples that will facilitate research on the mechanisms of hepatic injury due to drugs. Cases of liver injury due to herbal medications are also included. DILIN will develop standardized definitions of drug-induced liver disease and standardization of scoring systems for causality. Additional information can be obtained at: https://dilin.dcri.duke.edu

For more information, contact Dr. Jose Serrano, DDN, Director, Liver and Biliary Program and Pancreas Program.

Efficacy and Mechanisms of Glutamine Dipeptide in the Surgical Intensive Care Unit (GLND)

The GLND trial is a multi-center, double-blind, placebo-controlled, intent-to-treat Phase III trial, designed to determine the effect of parenteral glutamine (GLN) dipeptide on important clinical outcomes in patients requiring surgical intensive care unit (SICU) care and parenteral nutrition after cardiac, vascular, or intestinal surgery. Patients who required PN and SICU care will receive either standard glutamine (GLN)-free PN (STD-PN) or isocaloric, isonitrogenous alanyl-glutamine dipeptide (AG)-PN until enteral feedings are established. The study will determine whether AG-PN decreases hospital mortality, nosocomial infection and other important indices of morbidity and will obtain mechanistically relevant observational data in the subjects on whether AG-PN a) increases serial blood concentrations of glutathione (GSH), heat shock proteins (HSP)-70 and -27, and glutamine; b) decreases the serum presence of the bacterial products flagellin and lipopolysaccharide (LPS) and the adaptive immune response to these mediators; and c) improves key indices of innate and adaptive immunity. Additional information can be obtained at: http://www.sph.emory.edu/GLND 

For more information, contact Dr. Carolyn Miles, DDN, Director, Clinical Obesity and Nutrition Program.

 

Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD)

The EPISOD study is a prospective, double-blind, randomized, sham-controlled, multi-center clinical trial. The EPISOD study enrolls subjects who have received a prior cholecystectomy and are diagnosed with the clinical syndrome of Sphincter of Oddi Dysfunction III (SOD III) as defined by the Rome III criteria. The goal of the EPISOD study is to asses the value of endoscopic sphincterotomy as a treatment for adult subjects categorized as SOD III suffering from pain after cholecystectomy and to define the role of manometry in treating these patients. Additional information can be obtained at: www.episod.org

For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

Functional Dyspepsia Treatment Trial (FDTT)

The FDTT study is a multi-center, randomized, placebo-controlled trial evaluating the tricyclic antidepressant, amitriptyline and the selective serotonin reuptake inhibitor (SSRI), escitalopram to placebo in patients with functional dyspepsia. The purpose of this study is to determine whether amitriptyline and escitalopram are more efficacious than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidities.

For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

Gastroparesis Clinical Research Consortium (GpCRC)

The GpCRC is focusing on the etiology, natural history, and therapy of gastroparesis. The goal of this consortium is to perform clinical, epidemiological, and therapeutic research in gastroparesis and provide an infrastructure that can rapidly and efficiently design and conduct clinical trials for effective medical, surgical, or other interventions to improve treatment of patients with gastroparesis. The GpCRC studies comprise well characterized individuals with diabetic, surgical, and idiopathic gastroparesis. Additional information can be obtained at: www.jhucct.com/gpcrc

For more information, contact Dr. Frank Hamilton, DDN, Director, Gastrointestinal Motility Program.

Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) Trial

This prospective, randomized, controlled clinical trial studied long-term therapy with peginterferon in patients with chronic hepatitis C. Patient enrollment began in 2000 and was completed in 2003 at 10 clinical centers, which were supported by a data coordinating center, virological testing center, and central sample repository. Patients with chronic hepatitis C and advanced fibrosis or cirrhosis on liver biopsy who failed to respond to a previous course of interferon alfa were enrolled in this study. Patients were initially treated with a 24-week course of peginterferon alfa-2a and ribavirin. Patients who remained hepatitis C virus RNA positive were then randomized to receive maintenance, low-dose peginterferon or to be followed on no treatment. Liver biopsies were done before enrollment and after 2 and 4 years of treatment or follow-up. The endpoints were development of cirrhosis, hepatic decompensation, hepatocellular carcinoma, death, or liver transplantation. 1050 patients were randomized and followed through the 4 year randomized phase of the trial and as long as 4 years off treatment.  Serum samples collected at multiple time points, DNA and liver tissue are available for scientific investigation. Additional information can be obtained at: www.haltctrial.org 

For more information, contact Dr. Jay Everhart, DDN, Director, Epidemiology and Data Systems Branch.

High-dose Ursodiol Therapy of Primary Sclerosing Cholangitis (HUSC)

HUSC is a multi-center placebo-controlled trial of ursodiol in primary sclerosing cholangitis (PSC). A total of 150 patients with previously untreated PSC without cirrhosis were randomly assigned to receive high doses of ursodiol (20-25 mg/kg/day) or placebo for two years. Patients underwent medical evaluation, endoscopic retrograde cholangiography, and liver biopsy before randomization and again at two-year intervals. The endpoints of therapy were progression of hepatic fibrosis, liver decompensation, liver transplantation, or death. The treatment phase of the study was stopped for futility in June 2008; however, patients continue to be followed. Ongoing mechanistic studies are underway. Results from this study can be obtained at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2758780/?tool=pubmed

 For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

Inflammatory Bowel Disease Genetic Consortium (IBDGC)

The NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC) consists of investigators from seven sites in the U.S. and Canada, who have recruited a large sample of inflammatory bowel disease patients, their relatives, and control subjects. All of the individuals in this sample have been evaluated according to a standardized protocol for clinical traits related to IBD, and have donated blood samples as a source of DNA. The IBDGC investigators are conducting genetic linkage and association studies to identify genes influencing predisposition to IBD. Additional information can be obtained at: http://info.med.yale.edu/intmed/ibdgc/index.html 

Irritable Bowel Syndrome Outcome Study (IBSOS)

This multi-center clinical trial is designed to assess the short-term and long-term efficacy of cognitive behavior therapy (CBT) for irritable bowel syndrome (IBS) using two treatment delivery systems: self administered CBT and therapist administered CBT. Long term project goals are to develop an effective self-administered behavioral treatment program that can enhance the quality of patient care, improve clinical outcomes, and decrease the economic and personal costs of one of the most prevalent and intractable gastrointestinal disorders.

For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

Longitudinal Assessment of Bariatric Surgery (LABS) Consortium

The LABS consortium comprises six clinical centers and a data coordinating center. The goal of LABS is to facilitate coordinated clinical, epidemiological, and behavioral research in the field of bariatric surgery, through the cooperative development of common clinical protocols and a bariatric surgery database that will collect information from participating clinical centers. LABS will help pool the necessary clinical expertise and administrative resources to facilitate the conduct of multiple clinical studies in a timely, efficient manner. Also, the use of standardized definitions, clinical protocols, and data-collection instruments will enhance the investigator's ability to provide meaningful evidence-based recommendations for patient evaluation, selection, and follow-up care. The consortium was funded in September 2003. The investigators have collaboratively developed a core database and clinical protocols, and subject enrollment began in early 2005. Additional information can be obtained at: www.niddklabs.org

For more information, contact Dr. Carolyn Miles, DDN, Director, Clinical Obesity and Nutrition Program.

Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN)

The NASH CRN researches the nature and underlying cause of NASH and conducts clinical studies on prevention and treatment. Approximately 1,500 pediatric and adult participants throughout the United States and Canada with nonalcoholic fatty liver disease (NAFLD) have enrolled into a database which began in late 2003. The NASH CRN has recently reopened the database to enroll additional pediatric and adult participants with NAFLD. Serum, liver tissue, and genomic DNA samples are being collected and stored in the NIDDK repository for ongoing as well as future studies. A three-arm randomized, placebo-controlled clinical trial of pioglitazone versus vitamin E completed enrollment in 2009. In addition to this adult trial, a similar trial in pediatric NASH patients randomized 180 children to receive treatment with vitamin E, metformin, or placebo. Additional information can be obtained at: www.nashcrn.com

For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

Peginterferon and Ribavirin for Pediatric Patients with Chronic Hepatitis C (Peds-C)

This prospective, randomized controlled trial was completed in 2008 and studied peginterferon therapy, with or without ribavirin, in children with chronic hepatitis C. Approximately 120 children were randomly assigned to receive peginterferon alfa-2a alone or peginterferon with ribavirin for 48 weeks. Samples of blood, genomic DNA, and liver tissue are stored in the NIDDK repositories. A long-term follow up study of the clinical trial participants is underway. Additional information can be obtained at: http://www.hepatitis-central.com/hcv/symptoms/toc.html

For more information, contact Dr. Patricia Robuck, DDN, Director for Clinical Trials in Digestive Diseases and Nutrition Program.

Study of Nutrition in Acute Pancreatitis (SNAP)

SNAP is a randomized multi-center clinical trial designed to test whether duodenojejunal (DJ) feeding is more effective than nasogastric (NG) feeding in providing enteral nutrition to patients with severe acute pancreatitis. SNAP will enroll participants with severe acute pancreatitis admitted to the intensive care unit at eight clinical centers. Upon enrollment, participants are assigned to NG or DJ feeding and managed for up to 28 days or until weaned on to solid food. Follow-up continues until participants are discharged from the hospital or for a maximum of 60 days. Outcomes relate to feeding tolerance and failure, nutritional status, risk for life-threatening pancreatic/systemic complications, and hospital mortality. Additional information can be found at: www.snaptrial.org

For more information, contact Dr. Mary Evans, DDN, Director, Special Projects in Nutrition, Obesity, and Digestive Diseases.

Digestive Diseases Basic Research Networks

The AMDCC is an interdisciplinary consortium designed to develop animal models that closely mimic the human complications of diabetes for the purpose of studying disease pathogenesis, prevention and treatment. The consortium consists of thirteen “pathobiology sites” that study complications such as diabetic nephropathy, uropathy, neuropathy, cardiomyopathy and vascular disease. Additional goals of the AMDCC are to define standards to validate each diabetic complication for its similarity to the human disease, test the role of candidate genes that emerge from human genetic studies, and facilitate the exchange of animals, reagents, and expertise between members of the consortium and the greater scientific community. To ensure that all mice generated under the auspices of the AMDCC are phenotyped for a full duration of diabetes and across all relevant complications, the consortium has formed a close partnership with the NIDDK-funded Mouse Metabolic Phenotyping Centers (MMPCs). The MMPCs (www.mmpc.org) conduct detailed metabolic phenotyping of genetically altered mice and other mouse models that are useful for understanding diabetes and its complications, obesity, and related metabolic diseases or conditions.

For more information, contact Dr. Chris Ketchum, KUH, Director, Basic Renal Biology Program.

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The Centers are housed at outstanding academic institutions, staffed by experts in state-of-the-art technology. Researchers can ship mice to one of the four Centers and obtain on a fee-for-service basis a range of complex exams used to characterize mouse metabolism, blood composition including hormones, energy balance, eating and exercise, organ function and morphology, physiology and histology. Many tests are done in living animals and are designed to elucidate subtle to complex traits that would define models of metabolic disease.

For more information, contact Dr. Maren Laughlin, DEM, Senior Advisor for Integrative Metabolism.

NMRI is a communication network of current and potential biomedical research investigators and technical personnel from traditionally under-served communities: African American, Hispanic American, American Indian, Alaskan Native, Native Hawaiian, and other Pacific Islanders. The major objective of the network is to encourage and facilitate participation of members of underrepresented racial and ethnic minority groups in the conduct of biomedical research in the fields of diabetes, endocrinology, metabolism, digestive diseases, nutrition, kidney, urologic and hematologic diseases. A second objective is to encourage and enhance the potential of the underrepresented minority investigators in choosing a biomedical research career in these fields. An important component of this network is promotion of two-way communications between network members and the NIDDK.

For more information, contact Ms. Winnie Martinez, Program Analyst, Office of Minority Health Research Coordination.

Commensurate with this directive, NURSA's goals can be distilled into two broad aims: (i) to execute research strategies designed to rapidly and efficiently elucidate those facets of orphan nuclear receptor biology we deem most critical to its understanding; and (ii) to facilitate the generation of hypotheses, design of experiments and communication of results by scientists active in this field. We anticipate that this initiative will provide a valuable service to the nuclear receptor community by developing a web-accessible bioinformatics resource, in which current and emerging data will be organized into more accessible and "user-mineable" forms.

For more information, contact Dr. Ronald Margolis, DEM, Senior Advisor, Molecular Endocrinology.

Digestive Diseases Reagents

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The National Gene Vector Laboratories (NGVL) are composed of an interactive group of academic production and pharm/tox laboratories whose primary goal is to provide eligible investigators with clinical grade vectors for phase I/II gene therapy clinical trials and to provide support for relevant pharmacology/toxicology studies leading up to clinical gene transfer protocols. If the application is approved, clinical grade material will be produced at no cost to the investigator.

For more information, contact Dr. Catherine McKeon, DEM, Senior Advisor for Genetic Research in Diabetes, Endocrinology and Metabolic Diseases.

Digestive Diseases Services

A centralized facility established to provide genotyping and statistical genetics services for investigators seeking to identify genes that contribute to human disease. CIDR concentrates primarily on multifactorial hereditary disease although linage analysis of single gene disorders can also be accommodated.

For more information, contact Dr. Catherine McKeon, DEM, Senior Advisor for Genetic Research in Diabetes, Endocrinology and Metabolic Diseases.

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The Clinical Outcomes Research Initiative, CORI, provides gastrointestinal physicians, nurses and researchers with software, research data and tailor-made services aimed to advance the overall practice of endoscopy.

For more information, contact Dr. Jay Everhart, DDN, Director, Epidemiology and Data Systems Branch.

The Centers are housed at outstanding academic institutions, staffed by experts in state-of-the-art technology. Researchers can ship mice to one of the four Centers and obtain on a fee-for-service basis a range of complex exams used to characterize mouse metabolism, blood composition including hormones, energy balance, eating and exercise, organ function and morphology, physiology and histology. Many tests are done in living animals and are designed to elucidate subtle to complex traits that would define models of metabolic disease.

For more information, contact Dr. Maren Laughlin, DEM, Senior Advisor for Integrative Metabolism.

NIH RAID provides a variety of contract services researchers need to bring promising potential therapeutics to trial.

Digestive Diseases Standardization Programs

Digestive Diseases Tissues, Cells, Animals

The AMDCC is an interdisciplinary consortium designed to develop animal models that closely mimic the human complications of diabetes for the purpose of studying disease pathogenesis, prevention and treatment. The consortium consists of thirteen “pathobiology sites” that study complications such as diabetic nephropathy, uropathy, neuropathy, cardiomyopathy and vascular disease. Additional goals of the AMDCC are to define standards to validate each diabetic complication for its similarity to the human disease, test the role of candidate genes that emerge from human genetic studies, and facilitate the exchange of animals, reagents, and expertise between members of the consortium and the greater scientific community. To ensure that all mice generated under the auspices of the AMDCC are phenotyped for a full duration of diabetes and across all relevant complications, the consortium has formed a close partnership with the NIDDK-funded Mouse Metabolic Phenotyping Centers (MMPCs). The MMPCs (www.mmpc.org) conduct detailed metabolic phenotyping of genetically altered mice and other mouse models that are useful for understanding diabetes and its complications, obesity, and related metabolic diseases or conditions.

For more information, contact Dr. Chris Ketchum, KUH, Director, Basic Renal Biology Program.

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

http://www.med.umn.edu/peds/ltcds/   

The Liver Tissue Procurement and Distribution System (LTPADS) is a National Institutes of Health (NIH) service contract to provide human liver from regional centers for distribution to scientific investigators throughout the United States. These USA regional centers have active liver transplant programs with human subjects' approval to provide portions of the resected pathologic liver for which the transplant is performed. Frozen or fresh tissue is available from subcontractors for the usual forms of childhood and adult cirrhosis, fulminate liver failure, chronic rejection, and certain inborn errors of metabolism. “Normal” liver specimens may be requested, however, the supply is appropriately very limited and completion of large proposal requests is unlikely. A new service is now offered to provide isolated hepatocytes only to NIH investigators from "normal" human liver.

For more information, contact Dr. Jose Serrano, DDN, Director, Liver and Biliary Program and Pancreas Program.

The Centers are housed at outstanding academic institutions, staffed by experts in state-of-the-art technology. Researchers can ship mice to one of the four Centers and obtain on a fee-for-service basis a range of complex exams used to characterize mouse metabolism, blood composition including hormones, energy balance, eating and exercise, organ function and morphology, physiology and histology. Many tests are done in living animals and are designed to elucidate subtle to complex traits that would define models of metabolic disease.

For more information, contact Dr. Maren Laughlin, DEM, Senior Advisor for Integrative Metabolism.

The goal of the MMRRC program is to enhance the availability of and help ensure the quality of genetically modified mice for biomedical research of human and animal biology and disease.

For more information, contact Dr. Kristin Abraham, DEM, Director, Cell Signaling and Diabetes Centers Program.

Digestive Diseases Useful Tools

BMI for adults can be calculated using only height and weight.