Difficulty enrolling patients with elevated triglycerides under statin treatment

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.

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.

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

Total study period of 12 weeks