Phase 2 N=39 Randomized Quadruple-blind Treatment

Effects of Acipimox on Mitochondrial Function in Obesity

Abdominal Obesity · Insulin Resistance · Hypertriglyceridemia

Bottom Line

View on ClinicalTrials.gov: NCT01488409 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months — 1.7; 1.6 mM/s — p=0.97

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acipimox (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months	1.7; 1.6	0.97
SECONDARY Change From Baseline in Insulin Sensitivity at 6-months	0.1; 0.2	0.85
SECONDARY Change From Baseline in Mitochondrial Density at 6 Months	0.4; 0	0.52
SECONDARY Change From Baseline in Intramyocellular Lipid Content at 6-months	-0.2; 0.0	0.79
SECONDARY Change From Baseline in Lipid Profile at 6-months	-19; 6	0.007 sig

Summary

The purpose of the study is to examine whether a medication called acipimox can improve your body's mitochondria. Mitochondria are the "power house" of the cell and make energy for your body. Obesity is associated with increased risk for developing diabetes. However, the investigators do not know how obesity leads to diabetes. Previous studies have shown levels of fat in the blood (free fatty acids or FFA) are higher in obesity, and elevated FFA can affect how our body uses glucose and responds to insulin. Recent studies have shown that changes in mitochondria may be involved in the development of diabetes and may be affected by FFA. The investigators propose to improve the function of mitochondria in obese people with pre-diabetes by treating with acipimox, a medication which decreases FFA. The investigators will use state of the art techniques to evaluate the mitochondria, including a new magnetic resonance imaging (MRI) technique to measure function of mitochondria in muscle.

Eligibility Criteria

Inclusion Criteria

Men and women age 18-55 years old
Body Mass Index (BMI) ≥ 30 kg/m2
Waist circumference ≥ 102 cm in men and ≥ 88 cm in women
Hypertriglyceridemia defined as triglycerides ≥ 150 mg/dl OR Insulin resistance defined as elevated fasting glucose (≥ 100 mg/dl but 2 mg/dL), or liver disease (SGOT > 2.5 x upper limit normal).
Use of Aspirin, Clopidogrel (Plavix), Warfarin (Coumadin) or other anti-coagulants
History of or active peptic ulcer disease
History of any recent cardiovascular event including myocardial infarction (MI; heart attack), cerebral vascular accident (CVA; or stroke) or transient ischemic attack (TIA; or mini-stroke) within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
Subjects with contraindication for an MRI study including any significant metal in their body including surgical clippings, or pacemakers and known claustrophobia.
History of recent alcohol or substance abuse (< 1 year)
Positive pregnancy test or lactating females
Women of child-bearing potential not currently using non-hormonal birth control methods including barrier methods (intra-uterine device or IUD, condoms, diaphragms) or abstinence
Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01488409). 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.