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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 weeks

Change 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

Page last updated: August 23, 2015

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