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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00759291
First received: September 24, 2008
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Metabolic Syndrome
Drug: acipimox
Drug: matching placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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: 2 Drug: matching placebo
1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit

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 and eNOS phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 24, 2008
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
free fatty acids
insulin-mediated
endothelium-dependent vasodilation
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014