Status:
COMPLETED
Effects of Acipimox on Mitochondrial Function in Obesity
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
American Diabetes Association
Conditions:
Abdominal Obesity
Insulin Resistance
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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 \<125 mg/dl) or hyperinsulinemia defined as fasting serum insulin ≥ 10 uU/ml.
Exclusion
- Subjects on any hormonal treatment including estrogen, hormone replacement therapy, oral contraceptives, testosterone, glucocorticoids, anabolic steroids, GH, GH releasing hormone or Insulin like growth factor (IGF)-1 within 3months of enrollment.
- Subjects who have a known history of diabetes, using any anti-diabetic drugs, or fasting blood glucose of ≥ 125 mg/dl.
- Use of cholesterol lowering medication including niacin or fish oil.
- Changes in anti-hypertensive regimen within 3months of screening.
- Chronic illness including HIV, anemia (Hgb \<12 g/dL), chronic kidney disease (Creatinine \> 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.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01488409
Start Date
May 1 2012
End Date
January 1 2015
Last Update
March 1 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114