The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites investigator-initiated (R01) research project applications under PAR-12-265 for ancillary studies to ongoing large-scale clinical trials, epidemiological studies and disease databases supported by the Institute, other Institutes and Centers of the National Institutes of Health, other government agencies or the private sector. These studies are generally focused on a wide range of diseases and conditions including of direct interest to the NIDDK including diabetes, obesity, acute and chronic liver disease, chronic kidney disease, benign prostatic hyperplasia, among others. Studies of diseases and conditions outside the scope of the NIDDK may also lend themselves to ancillary studies under this PAR if the proposed ancillary studies are within the mission of the NIDDK. The goal of these ancillary study proposals must be to extend our knowledge of the diseases being studied by the parent study investigators under a defined protocol or to study diseases and conditions not within the original scope of the parent study but within the mission of the NIDDK. The proposed studies may require additional data or sample collection but may not interfere with the primary objectives of the main study. Each applicant must abide by the procedures for conducting ancillary studies established by the parent study.
Investigators interested in submitting an ancillary study grant application in response to this PAR are strongly revised to contact the appropriate initial NIDDK Program staff (see below) early in the process.
Inquiries should be directed as follows:
For studies related to digestive diseases and nutrition contact Dr. James Everhart at (301) 594-8878 or by e-mail at JE17G@mail.nih.gov.
For studies related to kidney and urologic diseases contact Dr. John Kusek at (301) 594-7735 or by e-mail at jk61x@nih.gov.
For studies related to diabetes mellitus contact Dr. Saul Malozowski at (301) 451-4683 or by e-mail at MalozowskiS@extra.niddk.nih.gov.
As examples, below is a list of the websites of NIDDK-sponsored, ongoing large-scale clinical research studies (“parent studies”) that are eligible for ancillary study grant applications under PAR-12-265. These websites provide information about ancillary studies to these parent studies.
Digestive Diseases and Nutrition parent study websites
A2ALL:
www.nih-a2all.org/ 
ALFSG:
www.utsouthwestern.edu/labs/acute-liver/about/
Childhood Liver Diseases Research and Education Network (ChiLDREN):
www.childrennetwork.org/
CORI:
www.cori.org/?topic=home
Drug-Induced Liver Injury Network (DILIN):
dilin.dcri.duke.edu/
Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD):
www.episod.org/
Gastroparesis Clinical Research Consortium (GpCRC):
jhuccs1.us/gpcrc/Default.asp
Efficacy and Mechanisms of Glutamine Dipeptide in the Surgical Intensive Care Unit (GLND):
www.sph.emory.edu/GLND/
Hepatitis B Research Network (HBRN):
www.hepbnet.org
Irritable Bowel Syndrome Outcomes Study (IBSOS):
ubbmc.buffalo.edu/research/ibsos.php
Inflammatory Bowel Disease Genetic Consortium (IBDGC):
medicine.yale.edu/intmed/ibdgc/index.aspx
iWITH:
www.rhoworld.com/rhonet/sam/
Longitudinal Assessment of Bariatric Surgery (LABS):
www.edc.gsph.pitt.edu/labs/
Action for Health in Diabetes (Look AHEAD):
www.lookaheadtrial.org/public/home.cfm
Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN):
jhuccs1.us/nash/
Pediatric Acute Liver Failure Study (PALFSG):
www.palfstudy.org
Porphyria:
rarediseasesnetwork.epi.usf.edu/porphyrias/index.htm
LIFE Moms:
lifemoms.bsc.gwu.edu/web/lifemoms/home
PROTECT:
www.cscc.unc.edu/protect/
Study of Nutrition in Acute Pancreatitis (SNAP):
www.snaptrial.org/
Adolescent Bariatrics: Assessing Health Benefits and Risks (Teen LABS):
http://www.cincinnatichildrens.org/research/divisions/t/teen-labs/default/
Kidney, Urologic and Hematologic Diseases supported parent studies
Chronic Renal Insufficiency Cohort (CRIC) Study:
porter.cceb.med.upenn.edu:7778/servlet/
Chronic Kidney Disease in Children (CkiD) Study:
http://www.statepi.jhsph.edu/ckid/
Focal segmental glomerulonephritis study:
clinicalresearch.ccf.org/fsgs/docs/index_docs.html
HALT-PKD:
http://haltpkd.org/index.html
Hemodialysis Fistula Maturation Cohort Study:
clinicalresearch.ccf.org/fm/ancillary_index.html
RIVUR:
www.cscc.unc.edu/rivur/faq.php
Diabetes Mellitus parent studies
The Environmental Determinants of Diabetes in the Young (TEDDY):
teddy.epi.usf.edu/
Type 1 Diabetes TrialNet:
www.diabetestrialnet.org/
The SEARCH for Diabetes Youth Study:
www.searchfordiabetes.org/
Treatment Options for Type 2 diabetes in Adolescents and Youth (TODAY):
today.bsc.gwu.edu/web/today/home
The Epidemiology of Diabetes Interventions and Complications Study (EDIC):
Investigators interested in collaborating with the DCCT/EDIC research group should contact Patricia Cleary at cleary@biostat.bsc.gwu.edu.
Restoring Insuln Secretion (RISE) Consortium:
Ancillary study guidelines are not now available but will be posted as soon as they are created.
Diabetes Prevention Program Outcomes Study (DPPOS):
www2.niddk.nih.gov/research/ClinicalResearch/DPPOS/QA.htm
