Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

NCT02422446 | Terminated Phase 3 Results

• 1 other identifier: 2013D003968
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Coronary Artery Disease

Keywords

Endothelial function; Eicosapentaenoic acid; Triglycerides

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI)

  Digital pulse amplitude will be measured with a fingertip peripheral arterial tonometry (PAT) device (Endo-PAT2000, Itamar Medical) in a supine position. Baseline pulse amplitude will be measured for 5 minutes, then the arterial flow will then be interrupted for 5 minutes with a cuff placed on a proximal forearm. Pulse amplitude will be recorded electronically and analyzed by a computerized and automated algorithm. The change from the baseline measurement will be expressed as the reactive hyperemia index (RHI). We will calculate the pulse amplitude response to hyperemia for each 30-second interval as a ratio of the post-deflation pulse amplitude to the baseline pulse amplitude as described previously. The RHI ratio will be computed by dividing the ratio obtained on the test side over the ratio from the control finger. We will assess change in RHI ratio between baseline value and 12-week value after the intervention.

  Between baseline and 12 weeks

Secondary Outcomes (1)

• Change in Endothelin-1 (ET-1), High-sensitive C-reactive Protein (hsCRP), and Oxidized LDL Between Baseline and 12 Weeks

  change between baseline and 12 weeks post-intervention

Study Arms (2)

EPA arm

EXPERIMENTAL

EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day

Drug: Icosapent ethyl

Control

NO INTERVENTION

Control group will not receive EPA

Interventions

Icosapent ethyl DRUG

icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish

Also known as: Vascepa, Eicosapentaenoic Acid, EPA

EPA arm

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Interventions

eicosapentaenoic acid ethyl ester; Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Dr. Luc Djousse
• Organization: Brigham and Women's Hospital

Ldjousse@rics.bwh.harvard.edu

617-525-7591

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 21, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 18, 2022
• Results First Posted: June 6, 2018

Record last verified: 2022-02

Locations

US (1)