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

Mass General Brigham

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metabolic Syndrome

Treatments: Drug: acipimox; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00759291

2005P-001861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

Acipimox

Active Comparator group

Description:

Acipimox treatment QID for 7 days

Treatment:

Drug: acipimox

Placebo

Placebo Comparator group

Description:

Placebo treatment QID for 7 days

Treatment:

Drug: Placebo