The National Institute of Diabetes & Digestive & Kidney Diseases

Digestive Diseases Databases, Registries and Information

The Acute Liver Failure Study Group is collecting biosamples and information on the natural history, causes and outcomes of Acute Liver Failure in the United States. In addition to the database, a clinical trial conducted to test whether the drug N-acetylcysteine (NAC) improves outcome (survival) for patients with Acute Liver Failure not caused by acetaminophen overdose has recently been completed. Results should be available in the near future.

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

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. Phenotype, genotype and pedigree data and DNA samples will be available through the NIDDK Repositories in 2008.

For more information, contact Dr. Robert Karp, DDN, Director, Genetics and Genomics Programs in Digestive Diseases and Obesity Programs.

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.

Digestive Diseases Multicenter Clinical Research

Look AHEAD (Action For Health in Diabetes) is a multi-center randomized clinical trial to examine the effects of a lifestyle intervention designed to achieve and maintain weight loss over the long term through decreased caloric intake and exercise. Look AHEAD is focusing on the disease most affected by overweight and obesity, type 2 diabetes, and on the outcome that causes the greatest morbidity and mortality, cardiovascular disease.

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

The Acute Liver Failure Study Group is collecting biosamples and information on the natural history, causes and outcomes of Acute Liver Failure in the United States. In addition to the database, a clinical trial conducted to test whether the drug N-acetylcysteine (NAC) improves outcome (survival) for patients with Acute Liver Failure not caused by acetaminophen overdose has recently been completed. Results should be available in the near future.

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

The primary goal of A2ALL is to provide valuable information on the outcomes of both potential and actual recipients and their donors who have been evaluated for adult-to-adult living donor liver transplantation.

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

The Biliary Atresia Research Consortium is a network of ten pediatric liver centers across the United States whose aim is to study causes and improve the diagnosis and treatment of infants and children with neonatal hepatitis and biliary atresia. Studies include a prospective database of infants with cholestatis and biliary atresia; A randomized, double-blinded, placebo-controlled trial of corticosteroid therapy following portoenterostomy in infants with biliary atresia; and, a database of older children with biliary atresia.

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

The Cholestatic Liver Disease Consortium (CLiC) is a network of ten pediatric liver centers, core research facilities and patient support organizations throughout the US and London, UK working together to investigate five genetic causes of intrahepatic cholestasis and to train the next generation of clinical researchers.

For more information, contact Dr. Patricia Robuck, DDN, Program 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.

To promote research on the causes of drug-induced liver disease, the National Institute of Diabetes and Digestive and Kidney Diseases has created the Drug-Induced Liver Injury Network (DILIN). Its purpose is to collect and carefully analyze cases of liver problems caused by prescription drugs and alternative medicines, such as herbal products.

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

This multicenter, double-blind, randomized, controlled phase III trial will test the hypothesis that alanyl-GLN (AG) a glutamine dipeptide, improves clinical outcomes in Surgical Intensive Care Unit (SICU) patients requiring parenteral nutrition after cardiac, vascular, or colonic operations.

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

This 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.

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

A consortium of 20 clinical sites and one data coordinating center studying the effect of antiviral therapy on long term outcome after liver transplantation for chronic hepatitis B virus infection. Enrollment is complete and analysis and ancillary studies are ongoing.

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

HALT-C is a multi-center randomized clinical trial to determine if four years of interferon therapy can prevent progression of liver disease in persons with severe liver injury who have not cleared hepatitis C virus with standard therapy.

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

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. Phenotype, genotype and pedigree data and DNA samples will be available through the NIDDK Repositories in 2008.

For more information, contact Dr. Robert Karp, DDN, Director, Genetics and Genomics Programs in Digestive Diseases and Obesity Programs.

The Longitudinal Assessment of Bariatric Surgery is a National Institutes of Health (NIH)-funded consortium of six clinical centers and a data coordinating center working in cooperation with NIH scientific staff to plan, develop, and conduct coordinated clinical, epidemiological, and behavioral research in the field of bariatric surgery.

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

This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplanation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected. Enrollment is now complete.

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

The objective of this multi-center study is to compare the safety and efficacy (effectiveness) of fixed versus individualized azathioprine dosing in Crohn’s disease patients in the induction of remission of steroid dependant and steroid refractory patients. Enrollment is ongoing.

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

The Nonalcoholic Steatohepatitis Clinical Research Consortium (NASH CRN) is a collaborative group of eight adult and pediatric clinical research centers and a data coordinating center created to focus on the etiology, contributing factors, natural history, complications, and therapy of nonalcoholic steatohepatitis. A long term database and a two clinical trials, one in adults and one in children, are ongoing.

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

The main purpose of this study is to determine the safety and efficacy of pegylated interferon in combination with ribavirin alone for the treatment of chronic hepatitis C virus infection in children. Enrollment in this study is complete.

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

This multi-center study is being conducted to evaluate the effectiveness of a new investigational medication, rosiglitazone, in controlling symptoms of ulcerative colitis. The medication is currently approved by the Food and Drug Administration (FDA) for the treatment of diabetes in adults. The study is complete. The results should be available shortly.

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

Studies of Pediatric Liver Transplantation, SPLIT, is a research effort that was organized in 1995 by a group of physicians and surgeons committed to the success of pediatric liver transplantation. The group represents a cooperative effort between transplant centers in the United States and Canada to prospectively collect and analyze information required to advance the science of pediatric liver transplantation.

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

A study conducted at eight clinical sites and included ancillary studies at four additional sites to evaluate factors associated with resistance to antiviral therapy in 400 African American and Caucasian American patients with chronic hepatitis C. All patients were treated with combination therapy of pegylated interferon and ribavirin for 48 weeks, and were followed for an additional 48 weeks after cessation of therapy. The study has been completed. Analyses and ancillary studies are ongoing.

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

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.

To promote research on the causes of drug-induced liver disease, the National Institute of Diabetes and Digestive and Kidney Diseases has created the Drug-Induced Liver Injury Network (DILIN). Its purpose is to collect and carefully analyze cases of liver problems caused by prescription drugs and alternative medicines, such as herbal products.

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.

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.

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.