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Boston, Massachusetts 02120


Purpose:

This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes.


Study summary:

Thirty adults aged 30-75 y will be randomized to either 4 g/d of eicosapentaenoic acid or no drug for 12 weeks. Endothelial function will be measured at baseline and after 12 weeks. in a secondary aims, we will evaluate effects of eicosapentaenoic acid (EPA) on plasma levels of c-reactive protein, oxidized low-density lipoprotein cholesterol, and endothelin-1.


Criteria:

Inclusion Criteria: - Age 30+ years - Hypertriglyceridemia (150-400 mg/dl) - Statin use for at least six months at the time of screening - Type 2 diabetes treated with diet and/or oral hypoglycemic agents diagnosed 1+ year - Ability to provide informed consent and provide blood samples - Willingness to abstain from fish oil, EPA, over the counter niacin, and other omega-3 fatty acid supplements during the study period (12 weeks) - Ability to travel to the study site at Brigham and Women's Hospital for 3 study visits - Reactive hyperemia index (RHI) of ≤ 2.0 Exclusion Criteria: - Eating disorder or heavy drinkers - Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification - Pregnant or lactating women - Statin use <6 months at the time of screening - Allergy to EPA, fish oil, or other omega-3 fatty acids - Current use of insulin, cyclophosphamide, estrogen, fibrates, niacin, hormone replacement therapy, testosterone, oral contraceptives, growth hormones, insulin-like growth factor-1, and other systemic steroids. - Inability to provide informed consent or blood samples - History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure - Diagnosis of diabetes < 1 year prior to enrollment - Intention to move out of greater Boston area within one year - Current use of omega-3 supplements, fish oil, or >2 servings of fish per week - Bleeding disorder or uncontrolled endocrine (i.e., thyroid) or metabolic disorders - Treatment with blood thinning drugs (i.e. warfarin and clopidogrel) - Major surgical operation 3 months before or after screening - Organ transplantation - Current participation in another trial or plan to do so during the study - Inability to give informed consent or to travel to the study center at Brigham and Women's Hospital - RHI of >2.0 - Triglycerides <150 mg/dl or >400 mg/dl - Body mass index of 40+ kg/m2


NCT ID:

NCT02422446


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02120
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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