Skip to main content
OpenTrials
Completed

NCT Number: NCT00759291

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acipimox

Drug

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

Other names: Olbetam

Placebo

Drug

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

Primary outcomes

  1. Flow Mediated Vasodilation

    Time frame: After 7 days of each treatment.

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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2008
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.