- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00759291
The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
February 17, 2023 updated by: Joshua A. Beckman, MD, Brigham and Women's Hospital
This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We hypothesize that acipimox, by decreasing plasma FFA concentrations, will augment endothelium-dependent vasodilation in conduit vessels and insulin-mediated vasodilation in forearm resistance arterioles in vivo, whole-body insulin sensitivity, and AKT (also known as Protein Kinase B) and endothelial nitric oxide synthase (eNOS) phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
- 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, 02115
- 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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:
- abdominal obesity
- elevated fasting blood sugar (110 mg/dL< glucose < 126 mg/dL)
- low HDL
- elevated fasting blood triglycerides (> 150 mg/dL)
- hypertension (BP > 140/90 mm HG)
- Normal cardiovascular examination
Exclusion Criteria:
- Diabetes mellitus
- Untreated hypercholesterolemia (LDL > 75th percentile for age)
- Cigarette smoking within 1 year
- Renal insufficiency (creatinine > 1.4 mg/dl)
- Blood dyscrasia
- Hepatic dysfunction (ALT > 2x normal)
- Evident coronary/peripheral atherosclerosis
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Acipimox
Acipimox treatment QID for 7 days
|
250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
Other Names:
|
Placebo Comparator: Placebo
Placebo treatment QID for 7 days
|
1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flow Mediated Vasodilation
Time Frame: After 7 days of each treatment.
|
Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period
|
After 7 days of each treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
April 1, 2006
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 30, 2017
Study Registration Dates
First Submitted
September 24, 2008
First Submitted That Met QC Criteria
September 24, 2008
First Posted (Estimate)
September 25, 2008
Study Record Updates
Last Update Posted (Estimate)
February 20, 2023
Last Update Submitted That Met QC Criteria
February 17, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005P-001861
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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