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Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

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Mass General Brigham

Status and phase

Terminated
Phase 3

Conditions

Coronary Artery Disease
Type 2 Diabetes

Treatments

Drug: Icosapent ethyl

Study type

Interventional

Funder types

Other

Identifiers

NCT02422446
2013D003968

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2 participants in 2 patient groups

EPA arm
Experimental group
Description:
EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day
Treatment:
Drug: Icosapent ethyl
Control
No Intervention group
Description:
Control group will not receive EPA

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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