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

Phase 2

Completed

• Conditions: Metabolic Syndrome
• Interventions: Drug: acipimox; Drug: Placebo

• Registration Number: NCT00759291
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-04-01
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-30
• Results First Submitted: 2021-05-10
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-17
• Last Update Submitted: 2023-02-17
• Results First Posted: 2023-02-21
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acipimox	acipimox	Acipimox treatment QID for 7 days
Placebo	Placebo	Placebo treatment QID for 7 days

Primary Outcome Measures

Name	Time	Method
Flow Mediated Vasodilation	After 7 days of each treatment.	Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States