Type 2 DiabetesPhase 3NCT02422446
Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects
A Phase 3 study testing Icosapent ethyl in people with Type 2 Diabetes and Coronary Artery Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Coronary Artery Disease
- What is being tested?
- Icosapent ethyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 1 Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Coronary Artery Disease
- Being tested
- Icosapent ethyl
- Keywords
- Endothelial function, Eicosapentaenoic acid, Triglycerides
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icosapent ethylDrug
Also called Vascepa, Eicosapentaenoic Acid, EPA
icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
| Study group | Role | What they receive |
|---|---|---|
| EPA arm | Experimental | EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day Receives: Drug: Icosapent ethyl |
| Control | No intervention | Control group will not receive EPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: change between baseline and 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Why it stopped: Difficulty enrolling patients with elevated triglycerides under statin treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Djousse, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422446
- Sponsor's protocol ID
- 2013D003968
- Status last verified
- Feb 2022
- First submitted
- 14 Apr 2015
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects: A Pilot Trial
- ClinicalTrials.gov ID
- NCT02422446
- Acronym / sponsor ID
- 2013D003968
- Conditions
- Type 2 Diabetes, Coronary Artery Disease
- Keywords
- Endothelial function, Eicosapentaenoic acid, Triglycerides
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients with elevated triglycerides under statin treatment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Posted 6 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPA arm | Experimental | Drug: Icosapent ethylEPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day |
| Control | No intervention | –Control group will not receive EPA |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Icosapent ethylAlso: Vascepa, Eicosapentaenoic Acid, EPAicosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish | Drug | EPA arm |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Icosapent ethyl in people with Type 2 Diabetes and Coronary Artery Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI) (time frame: Between baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.