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The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00759291
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: acipimox Drug: Placebo Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
Actual Study Start Date : April 1, 2006
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Acipimox
Acipimox treatment QID for 7 days
Drug: acipimox
250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
Other Name: Olbetam
Placebo Comparator: Placebo
Placebo treatment QID for 7 days
Drug: Placebo
1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit



Primary Outcome Measures :
  1. Absolute difference in flow-mediated, endothelium-dependent vasodilation of the brachial artery between the test agent and placebo [ Time Frame: following 1 week of drug/placebo ]
    endothelial function



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759291


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Joshua A. Beckman, M.D. Brigham and Women's Hospital

Responsible Party: Joshua A. Beckman, MD, Associate Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00759291     History of Changes
Other Study ID Numbers: 2005P-001861
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Joshua A. Beckman, MD, Brigham and Women's Hospital:
free fatty acids
insulin-mediated
endothelium-dependent vasodilation
metabolic syndrome

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Acipimox
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents