Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Eicosapentaenoic acid ethyl ester

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