Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects
Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes; Coronary Artery Disease
Intervention: Icosapent ethyl (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Brigham and Women's Hospital Overall contact: Luc Djousse, MD, ScD, Phone: 617-525-7591, Email: ldjousse@partners.org
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.
Clinical Details
Official title: Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects: A Pilot Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Primary outcome: Change from baseline in endothelial function at 12 weeks using reactive hyperemia index (RHI)
Secondary outcome: Change from baseline plasma high sensitive c-reactive protein at 12 weeksChange from baseline in oxidized LDL at 12 weeks Change from baseline in endothelin-1 at 12 weeks
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
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Luc Djousse, MD, ScD, Phone: 617-525-7591, Email: ldjousse@partners.org
Brigham and Women's Hospital, Boston, Massachusetts 02120, United States
Additional Information
Starting date: April 2015
Last updated: April 20, 2015
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