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Phase 3 Completed N=40 Randomized Quadruple-blind Basic Science

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

Source: ClinicalTrials.gov NCT00759291 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Flow Mediated Vasodilation — 9.5; 10.8; 10.5; 10.9 percentage of vasodilation
◆ Published Evidence
Emerging
12citations · ~2 / year
Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial.
Obesity (Silver Spring, Md.) · 2019 · Open access · High-confidence link

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.

Linked Publications (2)

  • Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial.
    Obesity (Silver Spring, Md.) · 2019 · 12 citations · Open access · High-confidence link
  • The Role of Serum Free Fatty Acids in Endothelium-Dependent Microvascular Function.
    Endocrinology, diabetes & metabolism · 2025 · 3 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Flow Mediated Vasodilation
9.5; 10.8; 10.5; 10.9

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) and the linked publication. 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. Informational only — not medical advice.

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