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http://www.ndep.nih.gov/

Federal government public education program that promotes diabetes prevention and control. They aim to reduce the morbidity and mortality associated with diabetes and its complications. The NDEP is jointly sponsored by the National Institutes of Health and the Centers for Disease Control and Prevention and over 200 partner organizations. Target audiences include people with diabetes and those at risk, including the racial and ethnic populations disproportionately affected by the disease, health care providers and payers and purchasers of health care.

Proper citation: National Diabetes Education Program (RRID:SCR_001477) Copy   

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http://www.bsc.gwu.edu/dpp/protocol.htmlvdoc

Observational clinical trial 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). The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. The DPPOS is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest IGT population ever studied. Clinically important research questions remain that focus on 1)durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding CVD, CVD risk factors and atherosclerosis and microvascular disease, 3)close examination of these topics in men vs women and in minority populations. More than 87% of the original surviving DPP cohort has joined DPPOS as of December, 2007 and, to date, after 5 years of DPPOS and 10 years of combined DPP/DPPOS, 93% of the DPPOS cohort continue to attend annual follow-up visits. Interim analyses performed after 5 years of DPPOS have demonstrated a durable effect of diabetes prevention associated with the lifestyle and metformin interventions with 34 and 19% reductions in diabetes incidence, respectively, compared with the placebo group. Interim analyses also reveal significant reductions from baseline in CVD risk factors in the lifestyle intervention group, but with decreased utilization of glucose-lowering and lipid-lowering medications. Analyses of the participants in the placebo group who have developed diabetes during DPP/DPPOS, compared with those who have remained non-diabetic, reveal an increased frequency of retinopathy and microalbuminuria. The current, updated protocol describes the DPPOS including the revisions incorporated to complete the second five-years of the study. DPPOS participants have blood samples stored at the time of each annual visit. Specimens are stored at the study CBL until after the primary study outcomes are reported. DNA samples were previously collected and are stored at the NIDDKsample repository for DPP participants.

Proper citation: Diabetes Prevention Program Outcomes Study (RRID:SCR_001502) Copy   

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https://labnodes.vanderbilt.edu/community/profile/id/2228

THIS RESOURCE IS NO LONGER IN SERVICE. Documented on August 13,2025.Core facility that provides access to isolated pancreatic islets from normal and diabetic models and performs islet functional analysis. The IPA Core also provides solutions for high-resolution whole slide imaging and access to image analysis tools for quantitative assessment of pancreatic islet morphology.

Proper citation: Vanderbilt Diabetes Research and Training Center Islet Procurement and Analysis Core (RRID:SCR_000896) Copy   

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http://www.med.upenn.edu/idom/drc/cores/mouse.html

Core which provides researchers with resources for performing metabolic studies in mice. It also provides services, innovative techniques, and helpful consultation to both experienced and novice investigators with regards to metabolic questions.

Proper citation: Penn Diabetes Research Center Mouse Phenotyping Physiology and Metabolism Core (RRID:SCR_000888) Copy   

•   Source: SciCrunch Registry

https://www.lookaheadtrial.org

16-center, randomized clinical trial investigating the long-term health consequences of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity in overweight volunteers with type 2 diabetes. 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. The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes * cardiovascular death (including fatal myocardial infarction and stroke), * non-fatal myocardial infarction, * hospitalized angina, and * non-fatal stroke, over a planned follow-up period of up to 13.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to the control condition, Diabetes Support and Education. Look AHEAD will also test for reductions in the incidence of three secondary composite outcomes and examine the effect of the intervention on cardiovascular disease risk factors, diabetes control and complications, general health, and quality of life, and psychological outcomes. The cost and cost-effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed. The Look AHEAD intensive lifestyle intervention ended September, 2012. Participants continue to be followed to determine the long-term effects of the intervention on health outcomes.

Proper citation: Look AHEAD (RRID:SCR_001490) Copy   

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https://repository.niddk.nih.gov/study/44

Randomized controlled clinical trial to understand how increasing hemodialysis to six times a week from the standard of three times a week may result in improved heart health. Subjects were recruited from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional hemodialyis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale. In addition, main secondary outcomes have been designated for each of seven outcome domains: 1) cardiovascular structure and function (change in LV mass), 2) health-related quality of life/physical function (change in the PHC), 3) depression/burden of illness (change in Beck Depression Inventory), 4) nutrition (change in serum albumin), 5) cognitive function (change in the Trail Making Test B), 6) mineral metabolism (change in average predialysis serum phosphorus), and 7) clinical events (rate of non-access hospitalization or death). Hypertension and anemia are also main outcome domains, but without designation of single first priority outcomes.

Proper citation: Frequent Hemodialysis Network Daily Trial (RRID:SCR_001527) Copy   

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https://repository.niddk.nih.gov/study/47

Study designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied. 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. 400 patients, half African-American and half Caucasian American, from 8 clinical centers with the goals of establishing rates of response to optimal current therapy in the two ethnic groups, identify factors predictive of response, establish patterns of viral kinetics in response to antiviral therapy, and test hypotheses concerning viral and host factors determining response to therapy. Four ancillary studies designed to elucidate biological and virological basis for non-response are also included in Virahep-C. Additionally, the study has central facilitates for pathology, the virological testing laboratory and a serum/tissue repository.

Proper citation: Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (RRID:SCR_001553) Copy   

•   Source: SciCrunch Registry

https://www.clinicaltrials.gov/study/NCT00392678?term=SALSALATE&viewType=Table&rank=8

Nationwide, randomized, double blind, multi-center research study to determine whether the drug salsalate, a member of the commonly used Non-Steroidal Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2 diabetes. The study is conducted in two stages. The primary objective of 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 primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk.

Proper citation: TINSAL-T2D (RRID:SCR_001546) Copy   

•   Source: SciCrunch Registry

https://www.clinicaltrials.gov/study/NCT00580749

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.

Proper citation: Study of Nutrition in Acute Pancreatitis (RRID:SCR_001544) Copy   

•   Source: SciCrunch Registry

http://archives.niddk.nih.gov/patient/crisp/rp-crisp.aspx

A five-year prospective cohort study following 240 patients who have autosomal-dominant polycystic kidney disease (PKD) to determine whether changes in anatomic characteristics of their kidneys as measured by magnetic resonance imaging will be useful in providing surrogate measures for disease progression. CRISP's overall goal is to develop methods that would facilitate shortening the observation period necessary to determine efficacy of treatment interventions in PKD patients. Specific goals of this study are to: * Quantify cyst growth and ascertain severity of renal parenchymal involvement by sequential measurement of total kidney volume and the ratio of intact parenchyma to renal parenchyma occupied by cysts over time * Establish useful clinical correlations of imaging data with other markers of disease progression * Identify and test other potential markers or indices of disease progression, for example, assessment of loss of heterozygosity of renal cells shed in the urine, or other markers, in cohorts of patients with PKD * Gain information about the cost-effectiveness, patient acceptability, and advantages and disadvantages of different imaging techniques used serially in patients with PKD. Some experience has been gained in establishing that repeat imaging of the same PKD patient, using these techniques, yields reproducible estimates of kidney size and the proportion of renal parenchyma occupied by cysts. MRI may also have the advantage of permitting simultaneous estimation of GFR. Ultrasound has the advantage of being more cost-effective and perhaps more acceptable to patients for repetitive studies, but the measurements may be less accurate and reproducible. Nonetheless, there is very limited experience in applying these techniques to follow progression of the renal disease. Development of improved, reproducible imaging methods that assess cyst growth and provide markers of disease progression could markedly improve the feasibility of clinical trials. Participating clinical centers are Emory University, the Mayo Clinic, University of Kansas, and the University of Alabama at Birmingham. The data coordinating and imaging analysis center is at Washington University. (PI has since moved to University of Pittsburgh) 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 III is a five-year prospective cohort study to follow ~170 remaining autosomal dominant polycystic kidney disease (ADPKD) patients who were part of the original CRISP cohort study. CRISP III will verify and extend the preliminary observations of CRISP to determine the extent to which quantitative (kidney volume and blood flow, 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. Urine metabolites and the genome will be correlated with the progression of disease to look for new, predictive disease biomarkers. This information from CRISP III will help determine if the kidney enlargement, blood flow, cyst distribution, or urine metabolites can function as an informative surrogate measure for disease progression.

Proper citation: Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (RRID:SCR_000690) Copy   

•   Source: SciCrunch Registry

http://www.t1diabetes.nih.gov/t1d-raid/index.shtml

NOTE: The T1D-RAID program is not currently accepting applications. Cooperative program that makes available, on a competitive basis, NCI resources for the pre-clinical development of drugs, natural products, and biologics to facilitate translation to the clinic of novel, scientifically meritorious therapeutic interventions for type 1 diabetes and its complications. A partial listing of those services includes: high-throughput screening, studies in animal models, formulation, pharmacology and toxicology studies, and bulk substances acquisition. Requests to T1D-RAID are brief (20 pages or less), and should clearly outline the resources required to ready the proposed therapeutic agent for clinical trials. T1D-RAID should enable entry into the clinic of promising molecules that are not otherwise likely to receive an adequate and timely clinical test. T1D-RAID is designed to accomplish the tasks that are rate-limiting in bringing discoveries from the laboratory to the clinic. Once a project has been approved, NIDDKstaff interact directly with the Principal Investigator (PI). NCI contractors perform the T1D-RAID-approved tasks under the direction of NIDDKand NCI staff. The required tasks will vary from project to project. In some cases T1D-RAID will support only one or two key missing steps necessary to bring a compound to the clinic; in other cases it may be necessary to supply the entire portfolio of development requirements needed to file an IND. Examples of tasks that can be supported by T1D-RAID include, but are not limited to: * Definition or optimization of dose and schedule for in vivo activity * Development of pharmacology assays * Conduct of pharmacology studies with a pre-determined assay * Acquisition of bulk substance (GMP and non-GMP) * Scale-up production from lab-scale to clinical-trials lot scale * Development of suitable formulations * Development of analytical methods for bulk substances * Production of dosage forms * Stability assurance of dosage forms * Range-finding initial toxicology * IND-directed toxicology, with correlative pharmacology and histopathology * Planning of clinical trials * Regulatory affairs, so that FDA requirements are likely to be satisfied by participating investigators seeking to test new molecular entities in the clinic * IND filing advice The output of T1D-RAID activities will be both products and information that will be made fully available to the originating investigator for support of an IND application and clinical trials. T1D-RAID does not sponsor clinical trials.

Proper citation: Type 1 Diabetes - Rapid Access to Intervention Development (RRID:SCR_000203) Copy   

•   Source: SciCrunch Registry

http://www.med.upenn.edu/idom/drc/cores/cellbio.html

Core that gives support including experimental design, islet isolation, and performance of and training in an expansive range of assays for physiological and morphometric assessment of pancreatic islet function and growth. It contributes to the basic and translational research activities of the Institute of Diabetes, Obesity and Metabolism (IDOM) at the Perelman School of Medicine of the University of Pennsylvania. Its services include perform individual islet and single cell fluorescence imaging, respirometry with islet batches using a Seahorse Extracellular Flux Analyzer, perifusion coupled with respirometry, and closed respirometry experiments for our investigators.

Proper citation: University of Pennsylvania School of Medicine Penn Diabetes Research Center Pancreatic Islet Cell Biology Core Facility (RRID:SCR_008265) Copy   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/show/NCT00100659

Multi-center, randomized controlled trial that 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 NIDDKrepositories. A long-term follow up study of the clinical trial participants is underway.

Proper citation: Peginterferon and Ribavirin for Pediatric Patients with Chronic Hepatitis C (RRID:SCR_006787) Copy   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/ct2/show/NCT00688662

A prospective, double-blind, randomized, sham-controlled, multi-center clinical trial that 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 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.

Proper citation: Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (RRID:SCR_006897) Copy   

•   Source: SciCrunch Registry

http://archives.niddk.nih.gov/patient/camus/camus.aspx

Randomized, multicenter, double blind, placebo controlled clinical trial of phytotherapy for benign prostate symptoms among men. The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills. This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Ten clinical centers will participate in the trial. They are located at: Columbia University, NY, NY; New York University, NY, NY; University of Texas Southwestern Medical Center, Dallas, Texas; University of Colorado, Denver, CO; Washington University, St. Louis, MO; Yale University, New Haven, CT; Queens University, Hamilton, Ontario, Canada; Northwestern University, Chicago, IL; University of Maryland, Baltimore, MD; University of California at San Francisco, San Francisco, CA.

Proper citation: Complementary and Alternative Medicine for Urological Symptoms (RRID:SCR_007131) Copy   

•   Source: SciCrunch Registry

http://archives.niddk.nih.gov/patient/fsgs/fsgs.aspx

Network of collaborative research centers that tested 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 was assessed in terms of induction of remission of proteinuria after 52 weeks of treatment and sustained remission after 26 weeks off treatment. The clinical sites were State University of New York, Stony Brook; Montefiore Medical Center; Seattle Children''''s Medical Center; Medical City Dallas Hospital; and the University of North Carolina. The Cleveland Clinic is the data-coordinating center, and NephCure will fund ancillary studies.

Proper citation: Focal Segmental Glomerulosclerosis in Children and Young Adults Interventional Study (RRID:SCR_007130) Copy   

•   Source: SciCrunch Registry

http://archives.niddk.nih.gov/patient/mist/mist.aspx

Randomized clinical trial 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. The study has been terminated. (Inability to recruit required sample size.)

Proper citation: Minimally Invasive Surgical Therapies Treatment Consortium for Benign Prostatic Hyperplasia (RRID:SCR_007126) Copy   

•   Source: SciCrunch Registry

http://www.einstein.yu.edu/centers/diabetes-translational-research/latino-network/

Research network dedicated to supporting translation research in diabetes prevention and control. The core has a strong emphasis on sociocultural adaption for Latinos in the U.S and can provide expertise in Latino biopsychosocial research.

Proper citation: New York Regional Center for Diabetes Translation Research Latino Network for Diabetes Translational Research (RRID:SCR_015189) Copy   

•   Source: SciCrunch Registry

http://www.einstein.yu.edu/centers/liver-research/research-cores/special-animals-core.aspx

Core that provides resources, technologies and scientific expertise to advance translational applications of animal and human liver cells. It also provides bred animals for research, isolation and culture of animal and human liver cells, as well as provision of cell culture additives and materials.

Proper citation: Marion Bessin Liver Research Center Animal Models Stem Cells and Cell Therapy (RRID:SCR_015181) Copy   

•   Source: SciCrunch Registry

http://www.einstein.yu.edu/centers/liver-research/research-cores/imaging-and-cell-structure-core.aspx

Core that supports and assists with use of specialized instrumentation, including laser scanning confocal microscopy, deconvolution microscopy, multi-photon microscopy, cryo-electron microscopy (cryo-EM) and correlative light electron microscopy (CLEM). It also provides expertise in and assistance with specialized imaging techniques such as correlative microscopy, vesicle tracking, volumetric measurements, ultrastructural sample preparation, super resolution fluorescence microscopy (STORM/SIM), Fluorescence Recovery After Photobleaching (FRAP), Fluorescence Resonance Energy Transfer (FRET) and Total Internal Reflection Microscopy (TIRF).

Proper citation: Marion Bessin Liver Research Center Imaging and Cell Structure (RRID:SCR_015182) Copy   

•   Source: SciCrunch Registry