Resources for Researchers : NIDDK Multicenter Clinical Research : NIDDK

Resources for Researchers : NIDDK Multicenter Clinical Research

Action for Health in Diabetes (Look AHEAD)
https://www.lookaheadtrial.org    Exit Disclaimer

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.


Action to Control Cardiovascular Disease Risk in Diabetes (ACCORD)
http://www.accordtrial.org/public/index.cfm    Exit Disclaimer

This NHLBI study is testing whether strict glucose control lowers the risk of heart disease and stroke in adults with type 2 diabetes. In addition the study is exploring two additional issues:1) Whether in the context of good glycemic control the use of different lowering lipid drugs will further improve these outcomes and 2) If strict control of blood pressure will also have additional beneficial effects on reducing cardiovascular disease.

For more information, contact Dr. Saul Malozowski, DEM, Senior Advisor for Endocrine Physiology.


Acute Renal Failure Trial Network (ATN) Study
http://www.atnstudy.org/    Exit Disclaimer

The Acute Renal Failure Trial Network (ATN) Study is a clinical research study that is jointly sponsored by the Department of Veterans Affairs and the National Institutes of Health in order to determine if an increased dose of dialysis will decrease mortality rates in patients with acute renal failure (ARF).

For more information, contact Dr. Robert Star, Director, Division of Kidney, Urologic, and Hematologic Diseases.


Adult Acute Liver Failure Study Group (ALFSG)
http://www8.utsouthwestern.edu/utsw/cda/dept25203/files/89624.html    Exit Disclaimer

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.


Adult To Adult Living Donor Liver Donor Liver Transplantation Cohort Study (A2ALL)
http://www.nih-a2all.org/    Exit Disclaimer

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.


African American Study of Kidney Disease and Hypertension (AASK) Clinical Trial and Cohort Study
http://www.niddk.nih.gov/patient/aask/aask.htm

African Americans are disproportionately afflicted with end-stage renal disease (ESRD). Although better management of high blood pressure has led to a decline in the number of people who develop strokes and heart disease, the number of people developing kidney failure has increased. In 1990, the NIDDK launched an initiative to investigate the underlying cause of ESRD and to study mechanisms that could slow progression of hypertensive kidney disease in African Americans. The clinical trial was initiated to investigate whether a specific class of antihypertensive drugs (beta-adrenergic blockers, calcium channel blockers, or angiotensin converting enzyme inhibitors) and/or the level of blood pressure would influence progression of hypertensive kidney disease in African Americans. The pilot study started in 1992 with its full-scale trial from 1995 to 2002 followed by a current Continuation of AASK Cohort Study. Only patients who were previously in the randomized trial are eligible for the cohort study. The primary goal of the Continuation of AASK Cohort Study is to investigate the environmental, socio-economic, genetic, physiologic, and other co-morbid factors that influence progression of kidney disease in a well-characterized cohort of African Americans with hypertensive kidney disease.

For more information, contact Dr. Lawrence Agodoa, KUH, Director, Office of Minority Health Research Coordination.


Autoimmunity Centers of Excellence (ACEs)
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The objective of this initiative is to support integrated centers of basic, pre-clinical and clinical research in autoimmunity, emphasizing novel approaches and state-of-the-art technology to increase our understanding of the basic mechanisms of autoimmunity and self tolerance and to translate that information to the clinical setting.

For more information, contact Dr. Beena Akolkar, DEM, Director, Immunopathogenesis and Genetics of Type 1 Diabetes Program.


Behavior Enhances Drug Reduction of Incontinence (BE-DRI)
http://www.uitn.net/    Exit Disclaimer

This study by the Urinary Incontinence Treatment Network (UITN) will determine if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will make it possible to discontinue the drug and still maintain a reduced number of accidents. The most popular treatments for urge incontinence are drug therapy and behavior therapy, each with its own limitations. In this clinical study, the UITN aims to determine differences with the addition of behavioral treatment to drug therapy alone.

For more information, contact Dr. Debuene Chang, KUH, Director, Urology and Women's Urological Health Programs; Urology SBIR Program.


Biliary Atresia Research Consortium (BARC)
http://www.barcnetwork.org/index.html    Exit Disclaimer

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.


Boston Area Community Health (BACH) Survey
http://www.niddk.nih.gov/patient/bach/BACH.htm

The Boston Area Community Health (BACH) Survey is an epidemiologic study being conducted in the Boston metropolitan area to examine the prevalence of symptoms for health problems such as interstitial cystitis, urinary incontinence, benign prostatic hyperplasia, prostatitis, hypogonadism, and sexual function. Of interest to the survey are health disparities and inequalities. BACH is especially concerned with lack of adequate health insurance, lack of access to adequate medical care, and how these problems influence patterns of disease. The study also focuses on social determinants of disease that are over and above the contribution of individual characteristics and risk factors. To achieve a randomly sampled population, four neighborhoods were divided into 12 strata and from them investigators selected census blocks. Households were then randomly selected from the census blocks and sampled to identify eligible study participants.

For more information, contact Dr. Paul Eggers, KUH, Director, Kidney and Urology Epidemiology Programs or Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.


Bypass Angioplasty Revascularization Investigation (BARI) 2 Diabetes
http://www.bari2d.org/    Exit Disclaimer

The NHLBI-led BARI-2D study aims to determine the best therapies for people with type 2 diabetes and moderately severe cardiovascular disease.

For more information, contact Dr. Teresa Jones, DEM, Director, Diabetes Complications Program.


Cholestatic Liver Diseases Consortium (CLiC)
http://rarediseasesnetwork.epi.usf.edu/clic/index.htm    Exit Disclaimer

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.


Chronic Prostatitis Collaborative Research Network Alpha Blocker Trial
http://porter.cceb.upenn.edu:7778/servlet/page?_pageid=243,245&_dad=portal30&_schema=PORTAL30    Exit Disclaimer

The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.


Chronic Renal Insufficiency Cohort (CRIC) Study
http://www.cceb.med.upenn.edu/cric    Exit Disclaimer

Chronic kidney disease (CKD) has been recognized as a silent epidemic affecting more than ten million Americans. The burden of morbidity and mortality from CKD derives from the progression of chronic renal insufficiency to end-stage renal disease (ESRD) and the disproportionate risk of cardiovascular disease (CVD) in the setting of CKD. The objectives of CRIC are to improve understanding of the relationship between CKD and CVD and to examine traditional and non-traditional (“uremia-related”) risk factors for progression of CKD and CVD among patients with reduced kidney function. The study, which started in 2001, is a prospective observational cohort study of approximately 3,000 men and women with CKD. This is the largest cohort study of CKD undertaken. A wide range of measurements are performed on CRIC Study participants including creatinine clearance and iothalamate measured glomerular filtration rate. Cardiovascular measures include blood pressure, ECG, ABI, ECHO, and EBCT. Clinical CV outcomes include MI, ischemic heart disease-related death, acute coronary syndromes, congestive heart failure, cerebrovascular disease, peripheral vascular disease, and composite outcomes.

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials.


CKID, A prospective cohort study of chronic kidney disease in children
http://www.statepi.jhsph.edu/ckid/      Exit Disclaimer

Pediatric chronic kidney disease (CKD) is usually due to a primary urologic problem or glomerular disease, rather than a secondary process such as diabetes or hypertension as in adults. In addition, unlike adults who have completed their physiological and intellectual maturation, children are at the early stages of these developmental processes and are particularly vulnerable to the adverse effects of chronic disease. The CKiD study is a prospective, observational cohort of children with mild to moderate CKD. The CKiD study population will include a cohort of 540 children, age 1 – 16 years, expected to be enrolled over a 24-month period. The specific aims of the CKiD study are to: (1) identify novel and traditional renal disease risk factors for the progression of CKD (i.e., decline of GFR) in children; (2) characterize the impact of a decline in kidney function on neurodevelopment, cognitive abilities, and behavior; (3) identify the prevalence and evolution of cardiovascular disease risk factors in children with CKD, and; (4) examine the effects of declining GFR on growth and the treatment of growth failure, and to assess the consequences of growth failure on morbidity in children with CKD.

For more information, contact Dr. Marva Moxey-Mims, KUH, Director, Kidney Centers Program; Pediatric Nephrology Program; Applied Kidney SBIR/STTR Program.


Clinical Outcomes Research Inititative (CORI)
http://www.cori.org/    Exit Disclaimer

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.


Clinical Trials in Organ Transplantation (CTOT)
http://www.ctotstudies.org/    Exit Disclaimer

The Clinical Trials in Organ Transplantation (CTOT) project is a cooperative research program sponsored by NIAID, NIDDK & NHLBI. This consortium is conducting clinical and associated mechanistic studies to facilitate improved outcomes for abdominal (kidney & liver) and thoracic (heart & lung) transplant recipients; short and long-term graft and patient survival.

For more information, contact Dr. Catherine Meyers, KUH, Director, Inflammatory Kidney Diseases Program.


Collaborative Islet Transplant Registry (CITR)
http://www.citregistry.org    Exit Disclaimer

The mission of CITR is to expedite progress and promote safety in islet/beta cell transplantation through the collection, analysis, and communication of comprehensive and current data on all islet/beta cell transplants performed in North America and soon some transplants in Europe and Australia. An Annual Report that is available on the public web site. This site serves as a repository for general information concerning protocols, clinical transplantation sites, publications, and other information of interest to the general community.

For more information, contact Dr. Michael Appel, DEM, Director, Islet Biology and Transplantation Research Program.


Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Clinical Trial
http://www.camus.uab.edu/camus/html/index.htm    Exit Disclaimer

The Complementary and Alternative Medicine for Urological Symptoms (CAMUS) is a randomized, placebo controlled trial of phytotherapy for benign prostate symptoms among men.

For more information, contact Dr. Leroy Nyberg, KUH, Director, Urology Programs.


Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II
http://www.niddk.nih.gov/patient/crisp/rp-crisp.htm

As many as half a million people in the US and 4-6 million world-wide are estimated to have Polycystic Kidney Disease (PKD). The most common form is autosomal dominant PKD (ADPKD). The original NIDDK funded Consortium of Radiologic Imaging Study of PKD (CRISP) measured the rates of change in total kidney volume and total cyst volume by MRI, and iothalamate GFR in 241 patients with ADPKD. The study found that kidney enlargement resulting from the expansion of cysts is continuous, quantifiable, and associated with the decline of renal function. Cystic expansion occurs at a consistent rate per individual, although it is heterogeneous in the population, and that larger kidneys are associated with more rapid decrease in renal function. These anatomic characteristics of patient kidneys may provide useful surrogate measures for disease progression, and hence enhance the development of targeted therapies for autosomal dominant PKD. CRISP II is a five-year prospective cohort study to follow 200 ADPKD patients who were part of the original CRISP cohort study. CRISP II will verify and extend the preliminary observations of CRISP to determine the extent to which quantitative (kidney volume and hepatic and kidney cyst volume) or qualitative (cyst distribution and character) structural parameters predict renal insufficiency and develop and test new metrics to quantify and monitor disease progression. This information from CRISP II will help determine if the kidney enlargement can function as an informative surrogate measure for disease progression.

For more information, contact Dr. Catherine Meyers, KUH, Director, Inflammatory Kidney Diseases Program or Dr. Laura Moen, KUH, Director, Renal and Urology Training, Renal Biochemistry and AIDS/HIV Programs.


Cooperative Study Group for Autoimmune Disease Prevention
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The mission of these Prevention Centers is to engage in scientific discovery which significantly advances knowledge for the prevention and regulation of autoimmune disease.

For more information, contact Dr. Beena Akolkar, DEM, Director, Immunopathogenesis and Genetics of Type 1 Diabetes Program.


Diabetes Control and Complications Trial (DCCT)
http://diabetes.niddk.nih.gov/dm/pubs/control/index.htm

The DCCT is a clinical study conducted from 1983 to 1993 by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The study showed that keeping blood glucose levels as close to normal as possible slows the onset and progression of eye, kidney, and nerve diseases caused by diabetes. EDIC is a follow-up study of people who participated in DCCT.

For more information, contact Dr. Catherine Cowie, DEM, Director, Diabetes Epidemiology Program.


Diabetes Prevention Program (DPP)
http://www.bsc.gwu.edu/dpp/index.htmlvdoc    Exit Disclaimer

The DPP showed that lifestyle change or metformin delay the development of type 2 diabetes. The DPPOS is a long-term follow-up study of the DPP participants.

For more information, contact Dr. Sanford Garfield, DEM, Senior Advisor for Biometry and Behavioral Research Program.


Diabetes Prevention Program Outcomes Study (DPPOS)
http://www.bsc.gwu.edu/dpp/protocol.htmlvdoc     Exit Disclaimer

The Diabetes Prevention Program Outcomes Study is studying the long term effect of diet and exercise and the diabetes medication, metformin, on the delay of type 2 diabetes in participants of the Diabetes Prevention Program (DPP).

For more information, contact Dr. Sanford Garfield, DEM, Senior Advisor for Biometry and Behavioral Research Program.


Diabetes Prevention Trial--Type 1 (DPT-1)
http://www.niddk.nih.gov/patient/dpt_1/dpt_1.htm

The Diabetes Prevention Trial--Type 1 (DPT-1) consisted of two clinical trials that sought to delay or prevent type 1 diabetes, also known as insulin-dependent diabetes. These efforts are being continued by the Type 1 Diabetes TrialNet consortium. See also DPT-1 Dataset.

For more information, contact Dr. Catherine Cowie, DEM, Director, Diabetes Epidemiology Program.


Diabetes Prevention Trial--Type 1 (DPT-1) dataset
https://www.niddkrepository.org/niddk/jsp/public/dataset.jsp#DPT-1    Exit Disclaimer

The Diabetes Prevention Type 1 (DPT-1) trial is a NIDDK-funded multi-center clinical trial to determine if treatment with beta-cell antigens can delay the onset of Type 1 Diabetes Mellitus (Type 1 DM) in non-diabetic relatives of persons with Type 1 DM. Insulin is a well characterized antigen specifically produced by beta-cells, and it was used for this purpose in the initial DPT-1 studies. The protocol for high risk subjects uses daily subcutaneous insulin injections and an annual course of intravenous insulin treatment, while the protocol for intermediate risk subjects uses daily doses of insulin administered orally.

For more information, contact Dr. Catherine Cowie, DEM, Director, Diabetes Epidemiology Program.


Diabetes Research in Children Network (DirecNet)
http://public.direc.net/    Exit Disclaimer

The mission of DirecNet is to investigate the potential use of glucose monitoring technology and its impact on the management of type 1 diabetes in children.

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


Diabetic Retinopathy Clinical Research Network (DRCR.net)
http://www.drcr.net/    Exit Disclaimer

The Diabetic Retinopathy Clinical Research Network (DRCR.net) is a collaborative network led by the National Eye Institute (NEI) dedicated to facilitating multicenter clinical research of diabetic retinopathy, diabetic macular edema and associated conditions. The DRCR.net supports the identification, design, and implementation of multicenter clinical research initiatives focused on diabetes-induced retinal disorders. Principal emphasis is placed on clinical trials, but epidemiologic outcomes and other research may be supported as well.


Dialysis Access Consortium (DAC)
http://www.niddk.nih.gov/patient/dac/DAC.htm  

Maintenance of vascular access is one of the major challenges in the care of dialysis patients. Two clinical trials under the Dialysis Access Consortium are studying the effects of anti-clotting agents in preventing graft and fistula failure.

For more information, contact Dr. Catherine Meyers, KUH, Director, Inflammatory Kidney Diseases Program.


Drug Induced Liver Injury Network (DLIN)
http://dilin.dcri.duke.edu/     Exit Disclaimer

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.


Efficacy Mechanisms of Glutamine Dipeptide in the SICU
http://www.sph.emory.edu/GLND/index.html     Exit Disclaimer

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.


Efficacy of Amitriptyline for painful bladder syndrome
http://www.ic-network.com/clinicaltrials/2005niddk.html     Exit Disclaimer

This trial will test an FDA-approved antidepressant for its potential to alleviate bladder pain for which there is no known cause and no effective therapy. Ten medical centers in the United States and Canada are recruiting adults newly diagnosed with either painful bladder syndrome (PBS) or interstitial cystitis (IC) to learn if the oral drug amitriptyline (Elavil®) will reduce the pain and frequent urination that are hallmarks of the conditions.
For more information, contact Dr. Leroy Nyberg, KUH, Director, Urology Programs.


Epidemiology of Diabetes Interventions and Complications (EDIC)
http://www.niddk.nih.gov/patient/edic/edic-public.htm
or http://www.bsc.gwu.edu/bsc/studies/edic.html     Exit Disclaimer

An observational study examining the risk factors associated with the long-term complications of type 1 diabetes. The study began in 1994 and follows the 1441 participants previously enrolled in the Diabetes Control and Complications Trial (DCCT).

For more information, contact Dr. Catherine Cowie, DEM, Director, Diabetes Epidemiology Program.



Family Investigation of Nephropathy of Diabetes (FIND)
http://darwin.cwru.edu/FIND    Exit Disclaimer

The FIND consortium is carrying out studies to elucidate the genetic susceptibility to kidney disease in patients, especially those with diabetes mellitus, as well as genetic susceptibility to retinopathy in diabetic patients. Because families of patients with diabetic nephropathy have an increased prevalence of renal disease and certain populations appear to be more susceptible, delineating the genetic loci associated with the development and progression of diabetic nephropathy could lead to improved outcomes. To accomplish this, the NIDDK established the Family Investigation of Nephropathy of Diabetes (FIND) Consortium in 1999. The overall goal of FIND is to identify genetic pathways that may be critical for the development of nephropathy and lead to candidates amenable to therapeutic strategies to prevent the onset or progression of nephropathy. Such data might aid identification of people at risk for the development of progressive renal disease.

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


Focal Segmental Glomerulosclerosis (FSGS) in Children and Young Adults Interventional Study
http://www.fsgstrial.org     Exit Disclaimer

The NIDDK has formed a collaborative network of research centers that will test the effects of treatment with cyclosporine to treatment with mycophenalate mofetil combined with oral pulse dexamethasone in children and young adults with focal segemental glomerulosclerosis. Efficacy will be assessed in terms of induction of remission of proteinuria after 52 weeks of treatment and sustained remission after 26 weeks off treatment.

For more information, contact Dr. Marva Moxey-Mims, KUH, Director, Kidney Centers Program; Pediatric Nephrology Program; Applied Kidney SBIR/STTR Program.


Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT)
http://www.cscc.unc.edu/favorit/favdescrip.htm    Exit Disclaimer

The Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) project is a multi-center, randomized, double blind controlled clinical trial sponsored by the National Institute of Diabetes & Digestive & Kidney Diseases. This study is designed to determine whether treatment with a standard multivitamin augmented with high doses of folic acid, vitamin B6 and vitamin B12 reduces the rate of cardiovascular disease outcomes in renal transplant recipients relative to participants receiving a similar multivitamin that contains no folic acid.

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials.


Frequent Hemodialysis Clinical Trials (FHN)
www.clinicaltrials.gov

The NIDDK-funded hemodialysis (HEMO) trial found that a modest increase in dialysis dose delivered 3 times a week did not improve mortality; however, the dose was not dramatically increased. The Frequent Hemodialysis Network (FHN) is testing two different approaches to increasing dialysis at Clinical Centers in the U.S. and Canada. The FHN Daily Trial is a randomized controlled trial that randomizes 250 subjects to either conventional hemodialysis delivered for at least 2.5 hours, 3 days per week, or to more frequent hemodialysis delivered for 1.5 – 2.75 hours, 6 days per week. Subjects will be followed for 12 months. The current FHN Nocturnal Trial randomizes 250 subjects to home conventional hemodialysis delivered three days per week or to nocturnal home hemodialysis given six times per week that provides a standardized Kt/V equal to or greater than 4 and treatment equal to or longer than 6.0 hours. Due to the necessity of training for home dialysis, subjects are followed for 14 months. Two outcomes are being assessed in both trials. The first is a composite measure of change in left ventricular mass or death. The second is a composite of change in the physical health composite of the SF36 or death.

For more information, contact Dr. Paul Eggers, KUH, Director, Kidney and Urology Epidemiology Programs or Dr. Andrew Narva, Director, National Kidney Disease Education Program; Senior Scientific Advisor.


Functional Dyspepsia Treatment Trial (FDTT)
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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.


Genetics of Kidneys in Diabetes Study (GoKinD)
http://www.gokind.org/access/home.html     Exit Disclaimer

The fundamental aim of GoKinD is to facilitate investigator-driven research into the genetic basis of diabetic nephropathy by collecting, storing, and distributing genetic samples from cases and controls of type 1 diabetes and diabetic nephropathy.

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


HALT PKD
http://www.pkd.wustl.edu/pkdtn/     Exit Disclaimer

As many as half a million people in the U.S. and 4-6 million world-wide are estimated to have Polycystic Kidney Disease (PKD). The most common form is the autosomal dominant PKD (ADPKD). The HALT PKD Consortium was established to design and implement clinical trials of treatments that might slow the progressive loss of renal function in PKD. Two multicenter randomized, double-blind, placebo controlled clinical trials are running concurrently to study the efficacy of renin-angiotensin-aldosterone system blockade on the progression of cystic disease (kidney volume) and on the decline in renal function in ADPKD. Study A is to study whether intensive ACE-I/ARB blockade decrease the progression of cystic disease compared to ACE-I monotherapy patients with early disease, relatively preserved renal function, and high-normal BP or hypertension. Study B is to study whether intensive ACE-I/ARB blockade as compared to ACE-I monotherapy slow the decline in kidney function, end-stage of renal disease, or death in the setting of standard blood pressure control in hypertensive patients with moderately advanced disease.

For more information, contact Dr. Catherine Meyers, KUH, Director, Inflammatory Kidney Diseases Program or Dr. Laura Moen, KUH, Director, Renal and Urology Training, Renal Biochemistry and AIDS/HIV Programs.


HEALTHY
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The HEALTHY study, which seeks to prevent risk factors for type 2 diabetes in middle school children, began in September 2006.

For more information, contact Dr. Barbara Linder, DEM, Senior Advisor for Childhood Diabetes Research.


Hepatitis B Orthotopic Liver Transplantation Study (HBV-OLTS)
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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.


Hepatitis C Antiviral Long Term Treatment Against Cirrhosis (HALT-C)
http://www.haltctrial.org/    Exit Disclaimer

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.


Immune Tolerance Network (ITN)
http://www.immunetolerance.org    Exit Disclaimer

The ITN is an international consortium of scientists and physicians dedicated to the clinical evaluation of novel tolerogenic approaches for the treatment of autoimmune diseases, asthma and allergic diseases, and the prevention of graft rejection.

For more information, contact Dr. Beena Akolkar, DEM, Director, Immunopathogenesis and Genetics of Type 1 Diabetes Program.


Inflammatory Bowel Disease Genetic Consortium (IBDGC)
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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.


Interstitial Cystitis Clinical Trials Group/Research Network (ICCRN), Events Preceding Interstitial Cystitis (EPIC)
http://www.ic-network.com/clinicaltrials/    Exit Disclaimer

The Interstitial Cystitis Clinical Trials Group, established by the NIDDK, has conducted clinical trials research into novel treatments for IC and studied potential biomarkers for the disease in urine. Recently, this group has been expanded to form the Interstitial Cystitis Clinical Network (ICCRN) to further assess potential new treatments for IC and foster basic research of IC and bladder disorders.

For more information, contact Dr. Paul Eggers, KUH, Director, Kidney and Urology Epidemiology Programs.


Islet Transplantation Trials for Type 1 Diabetes
http://www.isletstudy.org/     Exit Disclaimer

A network of centers will conduct studies of islet transplantation in patients with type 1 diabetes to improve the safety and long-term success of methods for transplanting islets.

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


Live Unrelated Kidney Donor and Sibling Follow-up Study (LURDS)
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This prospective cohort study will address whether kidney donation increases the risk of developing end-stage kidney disease and/or increases the risk of cardiovascular diseases. Pairs of living unrelated or distantly related kidney transplant donors and normal sibling controls will be enrolled and followed over time.

For more information, contact Dr. Catherine Meyers, KUH, Director, Inflammatory Kidney Diseases Program.


Longitudinal Assessment of Bariatric Surgery (LABS)
http://www.edc.pitt.edu/labs/    Exit Disclaimer

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.


Maryland Genetics of Interstitial Cystitis (MaGIC)
http://icresearch.umaryland.edu/magic.aspx    Exit Disclaimer

The MaGIC study will investigate several hundred families with two or more blood relatives with interstitial cystitis in order to understand the molecular genetic basis of this condition.

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


Minimally Invasive Surgical Therapies (MIST) Treatment Consortium for Benign Prostatic Hyperplasia (BPH)
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The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.


MTOPS Prostate Samples Analysis Consortium (MPSA)
http://www.niddk.nih.gov/patient/mpsa/MPSA.htm

Serum and biopsy samples from the MTOPS clinical trial represent a valuable resource for those seeking to develop and evaluate biological and genetic markers useful in the detection of BPH, or in predicting progression and response to therapy.

For more information, contact Dr. Chris Mullins, KUH, Director, Urology Basic Cell Biology Program.


Multicenter Randomized Trial of High Dose Ursodiol in Primary Sclerosing Cholangitis
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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.


Multi-site Trial of Azathioprine Dosing in Crohn's Disease
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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


Non-Alcoholic Steatohepatitis Clinical Research Network (NASH CRN)
http://www.jhucct.com/nash/     Exit Disclaimer

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.


Pediatric Acute Liver Failure Study Group (PALF)
http://www.palfstudy.org     Exit Disclaimer

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


Pegylated Interferon +/- Ribavirin for Children with HCV (Peds-C)
http://www.peds-c.org/      Exit Disclaimer

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.


Program to Reduce Incontinence by Diet and Exercise (PRIDE)
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PRIDE (Program to Reduce Incontinence by Diet and Exercise) is an exciting new research study to learn more about the effects of weight loss on urinary incontinence. About 330 overweight women aged 30 or older will participate in this randomized controlled trial. PRIDE is being conducted at two clinical centers in the United States and is coordinated by the Women's Health Clinical Research Center at the University of California, San Francisco.

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.


Randomized Intervention for Vesicoureteral Reflux (RIVUR)
http://www.rivur.net     Exit Disclaimer

The multicenter, randomized, double-blind, placebo-controlled RIVUR trial is designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of UTI in children with VUR. The basic eligibility criteria are: (1) age at randomization of at least 2 months, but less than 6 years, (2) a diagnosed first febrile or symptomatic UTI within 42 days prior to randomization that was appropriately treated, and (3) presence of Grade I-IV VUR based on voiding cystourethrogram (VCUG). Patients will be randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study is designed to recruit 600 children (approximately 300 in each treatment group) over an 18-24 month period. The primary endpoint is recurrence of UTI. In addition, patients will be evaluated for secondary endpoints related to renal scarring and antimicrobial resistance. Scarring will be determined based on renal scintigraphy by 99mTc dimercaptosuccinic (DMSA) scan. Quality of life, compliance, safety parameters, utilization of health resources, and change in VUR will be assessed periodically throughout the study.

For more information, contact Dr. Marva Moxey-Mims, KUH, Director, Kidney Centers Program; Pediatric Nephrology Program; Applied Kidney SBIR/STTR Program or Dr. Leroy Nyberg, KUH, Director, Urology Programs.


Randomized Trial of Rosiglitazone for Ulcerative Colitis
http://www.rucstudy.org/     Exit Disclaimer

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.


Renin Angiotensin System Study (RASS/B-RASS)
http://www.niddk.nih.gov/fund/divisions/kuh/kdcsi/RASS.pdf

The specific aim of this study was to determine whether treatment at the early stages of Diabetes mellitus (DM) can slow or stop diabetic nephropathy (DN) structural changes. Two hundred eight five pts ages 16-59 with 2-20 yrs of Type 1 DM and no renal functional abnormalities were randomized into a parallel, double-blind, placebo-controlled study involving 3 groups (95 pts/group). Each group received an angiotensin-converting enzyme inhibitor (ACEI) (enalapril), or an angiotensin II receptor blocker (Losartan), or placebo. All pts had their usual DM management. Baseline studies included measures of glomerular filtration rate (GFR), urinary albumin excretion rate (UAE), blood pressure (BP), and a percutaneous renal biopsy. Pts were followed by quarterly measures of BP, HbA1C, UAE, and drug compliance. There were annual measures of GFR and a repeat renal biopsy after 5 yrs in the study. The main endpoint is kidney structural changes over time, especially mesangial fractional volume [v(Mes/glom)]. Secondary endpoints will be other DN structural measures and measures of kidney function (UAE, GFR). These studies will determine whether rennin angiotensin system blockage in the early stages of DN can prevent the early kidney structural changes in this important disorder. Ancillary studies will evaluate the effects of treatment group on the development and progression of diabetic retinopathy and will develop predictors of study participants' compliance. The study has now been completed, and the data are being analyzed.

For more information, contact Dr. Marva Moxey-Mims, KUH, Director, Kidney Centers Program; Pediatric Nephrology Program; Applied Kidney SBIR/STTR Program.


SEARCH for Diabetes in Youth
http://www.searchfordiabetes.org/     Exit Disclaimer

SEARCH is a multi-center study that identifies cases of diabetes in children/youth < 20 years of age in six geographically dispersed populations that encompass the ethnic diversity of the United States.

For more information, contact Dr. Barbara Linder, DEM, Senior Advisor for Childhood Diabetes Research.


Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr)
http://www.uitn.net/     Exit Disclaimer

The primary aim of this clinical trial under the UITN is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.
 
For more information, contact Dr. Debuene Chang, KUH, Director, Urology and Women's Urological Health Programs; Urology SBIR Program.


Studies of Pediatric Liver Transplantation (SPLIT)
http://spitfire.emmes.com/study/lvr/     Exit Disclaimer

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.


Study of Viral Resistance to Antiviral Therapy of Hepatitis C (Virahep-C)
http://www.edc.gsph.pitt.edu/virahepc/     Exit Disclaimer

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.


Swedish Twin Registry Study of Interstitial Cystitis
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The overarching purpose of this proposal (Grant 5U01DK066134-03) is to address a set of critical questions about the etiology of interstitial cystitis (IC) using multivariate data from a large population-based classical twin study. Despite ongoing research, IC remains a controversial entity for two critical reasons. First, the validity of the case definition remains uncertain. There are few data that address a historically important validator--the degree to which IC results from genetic and/or environmental factors. Second, IC is often comorbid with one or more additional physical disorders and yet the causes of comorbidity are uncertain. Taken together, these two sets of unanswered questions contribute significantly to the controversies that continue to surround IC. Moreover, the strong female predominance of IC has been amply documented but is not well understood. To address these fundamental issues, it is proposed to conduct a twin study of IC in the population-based Swedish Twin Registry (STR). This study is part of the Interstitial Cystitis Genetics Consortium. The other part is the Maryland Genetics of Interstitial Cystitis (MaGIC) study.

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


Targeting Inflammation Using Salsalate for Type 2 Diabetes (TINSAL-T2D)
http://www.tinsal-t2d.org     Exit Disclaimer

The TINSAL-T2D study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group clinical trial. The primary objective of the study is to determine whether salicylates represent a new pharmacological option for glycemic control in patients with type 2 diabetes. The primary outcome for the study is change in HbA1c level from baseline to week 26 in the intent-to-treat (ITT) population with last observation carried forward. The study is conducted in two stages. The first stage is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The second stage is to evaluate (1) the effects of salsalate on glycemic control (HbA1c), (2) the tolerability of salsalate use, and (3) the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk. The implementation of the second stage is predicated on the successful selection of a dose in the first stage.

For more information, contact Dr. Myrlene Staten, DEM, Senior Advisor, Diabetes Research Translation Program.


The Environmental Determinant of Diabetes in the Young (TEDDY)
http://teddy.epi.usf.edu/     Exit Disclaimer

This consortium is organizing international efforts to identify infectious agents, dietary factors, or other environmental factors that trigger type 1 diabetes in genetically susceptible people.

For more information, contact Dr. Beena Akolkar, DEM, Director, Immunopathogenesis and Genetics of Type 1 Diabetes Program.


TODAY Trial
http://todaystudy.org/index.cgi     Exit Disclaimer

The TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) study seeks to identify the best treatment of type 2 diabetes in children and teens.

For more information, contact Dr. Barbara Linder, DEM, Senior Advisor for Childhood Diabetes Research.


Trial of Mid-Urethral Slings (TOMUS)
http://www.uitn.net/     Exit Disclaimer

In this clinical trial, the Urinary Incontinence Treatment Network (UITN) aims to compare two surgical approaches of minimally invasive procedures for the treatment of stress urinary incontinence.

For more information, contact Dr. Debuene Chang, KUH, Director, Urology and Women's Urological Health Programs; Urology SBIR Program.


Trial to Reduce IDDM in the Genetically at Risk (TRIGR)
http://trigr.epi.usf.edu/     Exit Disclaimer

The primary objective of this multi-center, international study is to determine whether weaning to a casein hydrolysate formula during the first 6-8 months of life in place of cow's milk based formula reduces the incidence of autoimmunity and type 1 diabetes in genetically susceptible newborn infants.

For more information, contact Dr. Beena Akolkar, DEM, Director, Immunopathogenesis and Genetics of Type 1 Diabetes Program.


Type 1 Diabetes TrialNet
http://www.diabetestrialnet.org/     Exit Disclaimer

This clinical network seeks to prevent type 1 diabetes in high-risk people and to preserve insulin production in those newly diagnosed.

For more information, contact Dr. Ellen Leschek, Type 1 Diabetes Trialnet Program Director.


Urinary Incontinence Treatment Network (UITN)
http://www.niddk.nih.gov/patient/uitn/uitn.htm
or http://www.uitn.net/      Exit Disclaimer

The network is a group of collaborating investigators who conduct long-term studies and clinical trials of the most commonly used surgical, pharmacological, and behavioral approaches for management of urinary incontinence in women diagnosed with stress and mixed incontinence.

For more information, contact Dr. Debuene Chang, KUH, Director, Urology and Women's Urological Health Programs; Urology SBIR Program.



Urological Pelvic Pain Collaborative Research Network (UPPCRN)
http://porter.cceb.upenn.edu:7778/servlet/page?_pageid=389,391,400&_dad=portal30&_schema=PORTAL30     Exit Disclaimer

The UPPCRN is the overarching organization for collaborative research in chronic prostatitis, chronic pelvic pain syndrome, and interstitial cystitis. It serves as the official NIDDK Working Group on chronic pelvic pain of urological origin, to facilitate interaction of study groups and investigators, both nationally and internationally, to advance our understanding, diagnosis, and treatment of these diseases.

For more information, contact Dr. John Kusek, KUH, Senior Scientific Advisor for Clinical Trials or Dr. Leroy Nyberg, KUH, Director, Urology Programs.


Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (VIRAHEP-C)
http://www.edc.gsph.pitt.edu/virahepc/     Exit Disclaimer

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 week safter 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.

Page last updated: December 15, 2008

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