Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

February 22, 2022 updated by: Luc Djousse, Brigham and Women's Hospital

Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects: A Pilot Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EPA arm
EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day
Drug: Icosapent ethyl
icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
Other Names:
  • Vascepa
  • EPA
  • Eicosapentaenoic Acid
NO_INTERVENTION: Control
Control group will not receive EPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI)
Time Frame: Between baseline and 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Endothelin-1 (ET-1), High-sensitive C-reactive Protein (hsCRP), and Oxidized LDL Between Baseline and 12 Weeks
Time Frame: change between baseline and 12 weeks post-intervention
Plasma hsCRP will be measured by Sandwich enzyme linked immunosorbent assay (ELISA). Plasma oxidized LDL and plasma ET-1 will be measured using a commercially available sandwich-enzyme immunoassay kit (R & D).
change between baseline and 12 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (ESTIMATE)

April 21, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013D003968

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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