Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects
Condition: Type 2 Diabetes; Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Icosapent ethyl
Intervention description: icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Endothelial function; Eicosapentaenoic acid; Triglycerides

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.
    

Eligibility 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