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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-01

Study Completion Date

2017-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acipimox

Acipimox treatment QID for 7 days

Group Type ACTIVE_COMPARATOR

acipimox

Intervention Type DRUG

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

Placebo

Placebo treatment QID for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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acipimox

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Olbetam

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes