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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
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
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
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
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
http://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html
A listing of NIH supported data sharing repositories that make data accessible for reuse. Most accept submissions of appropriate data from NIH-funded investigators (and others), but some restrict data submission to only those researchers involved in a specific research network. Also included are resources that aggregate information about biomedical data and information sharing systems. The table can be sorted according by name and by NIH Institute or Center and may be searched using keywords so that you can find repositories more relevant to your data. Links are provided to information about submitting data to and accessing data from the listed repositories. Additional information about the repositories and points-of-contact for further information or inquiries can be found on the websites of the individual repositories.
Proper citation: NIH Data Sharing Repositories (RRID:SCR_003551) Copy
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
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
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
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
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
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
http://www.med.unc.edu/microbiome
Core facility that provides the research community with the facilities and the expertise to characterize complex microbial communities from different environments.Services offered by the Core include metagenomics methods to determine the composition and function of microbial communities using amplicon, Whole Genome Shotgun (WGS) and RNA sequencing, and traditional and high-throughput quantitative (q)PCR.
Proper citation: University of North Carolina Center for Gastrointestinal Biology and Disease Microbiome Core (RRID:SCR_012644) Copy
http://clinicaltrials.gov/show/NCT00143949
Randomized, multicenter, double-blind study to determine if renin angiotensin medications, either losartan (angiotensin II blocker) or enalapril (converting enzyme inhibitor), can prevent or delay the onset of diabetic kidney disease in patients with type 1 diabetic patients who do not have hypertension, diabetic nephropathy, or predictive levels of microalbuminuria. Two hundred eight five patients ages 16-61 with 2-20 yrs of Type 1 Diabetes Mellitus and no renal functional abnormalities were randomized into a parallel, double-blind, placebo-controlled study involving 3 groups (95 patients/group). Each group received an angiotensin-converting enzyme inhibitor (ACEI) (enalapril), or an angiotensin II receptor blocker (Losartan), or placebo. All patients had their usual Diabetes Mellitus (DM) management. Baseline studies included measures of glomerular filtration rate (GFR), urinary albumin excretion rate (UAE), blood pressure (BP), and a percutaneous renal biopsy. Patients 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. Baseline, 2.5 and 5 year retinal fundus photographs in the RASS patients were obtained.
Proper citation: Renin Angiotensin System Study (RRID:SCR_013385) Copy
https://einsteinmed.edu/centers/diabetes-research/human-Islet-and-adenovirus-core/
Core which provides methodologies, technology and infrastructure to support investigators in the use of human islets for research studies for the Einstein-Mount Sinai Diabetes Research Center. It isolates and prepares human and rodent islets/beta cells and cell lines for investigator-initiated research and generates specific viral vectors (adenovirus and lentivirus) for gene delivery of cDNAs and shRNAs of interest to beta cells and other islet cell types.
Proper citation: Einstein-Mount Sinai Diabetes Research Center Human Islet and Adenovirus Core Facility (RRID:SCR_015066) Copy
https://einsteinmed.edu/research/shared-facilities/barc/
Core provides information and tools for Einstein and Montefiore investigators from initial study planning stage through analysis and data output. Facility services include: mass spectrometry analysis, including stable isotopes, as well as research-grade determination of lipids, and metabolic markers for human subjects and animal model projects; High-throughput robotics for semi-automated high-quality sample preparation and analysis by immunoassay and liquid chromatography–mass spectrometry (LC/MS); Support for novel developmental projects featuring applications of LC/MS and two-site bead-based assays; Research quality analysis of metabolites for human and animal samples using Olympus AU400 autoanalyzer; Advanced training in analytical chemistry.
Proper citation: Einstein-Mount Sinai Diabetes Research Center Biomarker Analytic Research Core Facility (RRID:SCR_015067) Copy
http://drc.ucsf.edu/mouse-genetics-core
THIS RESOURCE IS NO LONGER IN SERVICE. Documented on November 5,2024. Core that provides a shared resource for the establishment of mutant mouse models for DRC research. It coordinates DRC members with contacts to a number of UCSF-wide facilities for knock-out/knock-in and transgenic mouse generation.
Proper citation: University of California San Francisco Diabetes Research Center Mouse Genetics Core Facility (RRID:SCR_015109) Copy
http://www.uab.edu/shp/drc/administrative-core-links
Core responsible for the scientific, education/enrichment, and fiscal operations of the DRC. Their goal is to assure the growing vitality of an intellectual community and a highly productive research program in diabetes by effective deployment of DRC resources for the benefit of our investigators, patients, and trainees.
Proper citation: University of Alabama at Birmingham Diabetes Research Center Administrative Core Facility (RRID:SCR_015108) Copy
http://www.uab.edu/shp/drc/bioanalytical-redox-biology-core-barb-links
Core which promotes redox biology in diabetes-related research. It promotes research in areas common to the metabolic and vascular aspects of diabetes and cardiovascular disease. The core provides services in mitochondrial damage, function, proteomics, and oxidative stress assessment support for investigators carrying out diabetes mellitus (DM) and cardiometabolic disease (CMD) research at UAB.
Proper citation: University of Alabama at Birmingham Diabetes Research Center Bioanalytical REDOX Biology Core Facility (RRID:SCR_015113) Copy
https://www.derc.cuimc.columbia.edu/services/translational-biomarker-analytical-core
Core makes available to Diabetes Research Center investigators variety of high quality radio-immunoassay, ELISA, and other analytical methods, and facilitates access of DRC investigators to measurement of small molecules by targeted and untargeted metabolomics/lipidomics with the Irving Institute Biomarkers Core. TBAC also provides consultations and services for in vivo methods to measure insulin secretion and sensitivity.
Proper citation: Columbia Diabetes Research Center Translational Biomarker Analytical Core Facility (RRID:SCR_015077) Copy
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