Sponsor study identifier
Secondary identifiers
interventional
47
1 country
1
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatment for this a medication called fenofibrate, another medication that can improve insulin resistance is rosiglitazone, a third treatment known to improve insulin resistance an decrease triglycerides is weight loss. In this study insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of these treatments and results of insulin sensitivity and cardiac risk profiles will be compared at the end of the study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 14, 2005
Actual (reported)September 16, 2005
Actual (reported)September 2008
Actual (reported)September 2008
Actual (reported)May 5, 2016
Actual (reported)Pre- and Post-Intervention Triglyceride Levels
Compare the change in mean triglyceride levels between groups after the interventions
Baseline, 12 weeks
Pre- and Post-Intervention LDL Cholesterol Levels
Compare the change in mean LDL Cholesterol levels between groups after the interventions
Baseline, 12 weeks
Pre- and Post-Intervention HDL Cholesterol Levels
Compare the change in mean HDL Cholesterol levels between groups after the interventions
Baseline, 12 weeks
160 mg daily for 12 weeks
4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks
calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks
Stanford University Medical Center
Stanford, California, 94305, United States
Reaven GM. Banting lecture 1988. Role of insulin resistance in human disease. Diabetes. 1988 Dec;37(12):1595-607. doi: 10.2337/diab.37.12.1595.
Laws A, Reaven GM. Evidence for an independent relationship between insulin resistance and fasting plasma HDL-cholesterol, triglyceride and insulin concentrations. J Intern Med. 1992 Jan;231(1):25-30. doi: 10.1111/j.1365-2796.1992.tb00494.x.
Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002 Jan 16;287(3):356-9. doi: 10.1001/jama.287.3.356.
Gerald M Reaven, MD
Stanford University
47 participants (actual enrollment reported by the registry).
First Submitted
September 14, 2005
First Posted
September 16, 2005
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Docosahexenoic Acid (DHA) Supplementation and Cardiovascular Disease in Men With High Triglycerides
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
January 12, 2017
Results First Posted
May 5, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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