Clinical trial NCT02422446: Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects
Official title: Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Coronary Artery Disease
Keywords: Endothelial function
Eicosapentaenoic acid
Triglycerides
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI)
timeFrame: Between baseline and 12 weeks
Secondary outcomes:
measure: Change in Endothelin-1 (ET-1), High-sensitive C-reactive Protein (hsCRP), and Oxidized LDL Between Baseline and 12 Weeks
timeFrame: change between baseline and 12 weeks post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: