Back to resultsThe Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
acipimox
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Syndrome focused on measuring free fatty acids, insulin-mediated, endothelium-dependent vasodilation, metabolic syndrome
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Acipimox
Placebo
Arm Description
Acipimox treatment QID for 7 days
Placebo treatment QID for 7 days
Outcomes
Primary Outcome Measures
Flow Mediated Vasodilation
Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period
Secondary Outcome Measures
Full Information
NCT ID
NCT00759291
First Posted
September 24, 2008
Last Updated
February 17, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00759291
Brief Title
The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
Official Title
The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2006 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
free fatty acids, insulin-mediated, endothelium-dependent vasodilation, metabolic syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acipimox
Arm Type
Active Comparator
Arm Description
Acipimox treatment QID for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment QID for 7 days
Intervention Type
Drug
Intervention Name(s)
acipimox
Other Intervention Name(s)
Olbetam
Intervention Description
250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
Primary Outcome Measure Information:
Title
Flow Mediated Vasodilation
Description
Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period
Time Frame
After 7 days of each treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua A. Beckman, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31571412
Citation
Aday AW, Goldfine AB, Gregory JM, Beckman JA. Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial. Obesity (Silver Spring). 2019 Nov;27(11):1812-1819. doi: 10.1002/oby.22602. Epub 2019 Oct 1.
Results Reference
result
Learn more about this trial
The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
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