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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759291
• Other study ID #: 2005P-001861
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 1, 2006
• Est. completion date: December 30, 2017

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Drug:
• acipimox
250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
• Placebo
1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aday AW, Goldfine AB, Gregory JM, Beckman JA. Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial. Obesity (Silver Spring). 2019 Nov;27(11):1812-1819. doi: 10.1002/oby.22602. Epub 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow Mediated Vasodilation	Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period	After 7 days of each treatment.