The Effects of Short Term Acipimox Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Acipimox
Treatment with the study drug Acipimox
干预措施: Acipimox (Drug)
Placebo
Treatment with Placebo control.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months
时间窗: Change from Baseline to 6-months Visit
The rate of recovery of phosphocreatine concentration after depletion by exercise is considered a measurement of mitochondrial function. Change in phosphocreatine recovery from baseline to 6 months will therefore give a measurement of change in mitochondrial function. ViPCR is given -- a higher value indicates better mitochondrial function.
次要结局
- Change From Baseline in Mitochondrial Density at 6 Months(Change from Baseline to 6-months)
- Change From Baseline in Insulin Sensitivity at 6-months(Change from Baseline to 6-months visit)
- Change From Baseline in Intramyocellular Lipid Content at 6-months(Change from Baseline to 6-months)
- Change From Baseline in Lipid Profile at 6-months(Change from Baseline to 6-months)
研究者
Steven K. Grinspoon, MD
Professor of Medicine
Massachusetts General Hospital