- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02422446
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
-
-
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
|
icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
Other Names:
|
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
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
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.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
San Luigi Gonzaga HospitalRecruitingCoronary Disease | STEMI | Coronary Artery Ectasia | Right Coronary Artery Occlusion | Right Coronary Artery StenosisSpain, Italy
Clinical Trials on Icosapent ethyl
-
New York State Psychiatric InstituteWithdrawnBipolar DisorderUnited States
-
Kaiser PermanenteAmarin CorporationTerminatedCardiovascular Diseases | Covid19 | Atherosclerosis | Upper Respiratory Tract InfectionsUnited States
-
Mochida Pharmaceutical Company, Ltd.Completed
-
Lundquist Institute for Biomedical Innovation at...Intermountain Research and Medical FoundationCompletedHypertriglyceridemiaUnited States
-
University of PennsylvaniaAmarin Pharma Inc.CompletedDyslipidemias | Lipid Disorder | Triglycerides HighUnited States
-
Matinas BioPharma Nanotechnologies, Inc.MB Clinical Research and Consulting LLC; Matinas Biopharma, IncCompletedHypertriglyceridemiaUnited States
-
VA Office of Research and DevelopmentUniversity of Wisconsin, MadisonCompletedAlzheimer's DiseaseUnited States
-
Estudios Clínicos Latino AméricaAmarin Pharma Inc.Completed
-
Canadian Medical and Surgical Knowledge Translation...Unity Health Toronto; Western University, Canada; HLS Therapeutics, IncCompletedCardiovascular Diseases | Diabetes Mellitus, Type 2 | Cardiovascular Risk Factor | Triglycerides HighCanada
-
Massachusetts General HospitalHarvard School of Public Health (HSPH)WithdrawnColon CancerUnited States