Phase 3 N=40 Randomized Quadruple-blind Basic Science

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

Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00759291 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Flow Mediated Vasodilation — 9.5; 10.8; 10.5; 10.9 percentage of vasodilation

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: acipimox (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Flow Mediated Vasodilation	9.5; 10.8; 10.5; 10.9	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00759291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.