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

Brigham and Women's Hospital40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

acipimoxDRUG

250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit

PlaceboDRUG

1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Flow Mediated Vasodilation

Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period

Time frame: After 7 days of each treatment.

Data from ClinicalTrials.gov

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