Synergistic Induction of UCP-1 by Ephedrine/Caffeine and Pioglitazone: A Rationale for Combination Therapy of Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Percent fat after 16 weeks treatment using a Hologic QDR 4500 DEXA.
研究概览
简要总结
This study compares four treatments to see which one causes the most weight loss, fat loss, loss of abdominal fat and improvement in blood tests like cholesterol. The four treatments are: Placebo, Ephedrine plus caffeine, Pioglitazone, Combined pioglitazone and ephedrine plus caffeine
详细描述
The sympathetic nervous system, via the intracellular messenger cAMP and MAPK activation, and thiazolidinediones via PPARγ control lipid metabolism have been implicated in body weight regulation. The present study was undertaken to determine whether the simultaneous activation of these two signaling systems might synergize to exert beneficial effects on the expression of key genes involved in lipid metabolism and mitochondrial biogenesis in subcutaneous fat in healthy, non-diabetic subjects. Fifty seven non-diabetic women and men were randomized into four groups: 1) placebo/placebo (PP); 2) ephedrine plus caffeine/placebo (ECP); 3) placebo/pioglitazone (PPio); 4) ephedrine plus caffeine/pioglitazone (ECPio). Adipose tissue samples were obtained after 12 weeks of treatment to determine gene expression by real time RT-PCR.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy
- •not pregnant or nursing
- •using adequate contraception
- •between 18 and 50 years of age
- •BMI between 30 and 35 kg/m2
排除标准
- •significant renal, cardiac, liver, lung or neurological disease
- •high blood pressure
- •prior use of thiazolidinedione
- •prior use of beta-blockers alcohol or drug abuse
- •history of thrombophlebitis, vascular or blood clotting disorders
- •unwilling or unable to abstain from caffeinated beverages and alcohol prior to adipose tissue biopsy and metabolic rates measurements
- •increased liver function test at baseline
- •have metal objects that would interfere with the measurement of the body composition
- •use drugs known to affect lipid metabolism, energy metabolism or body weight
- •use herbal supplements containing ephedrine and/or caffeine
- •take chronic medication, except hormone replacement or contraception
- •are a woman unwilling to use effective contraception during the trial
- •have heart disease or history of stroke
- •have urinary symptoms from enlarged prostate
- •have gained and or lost more than 10 pounds in the last 6 month
- •have use a monoamine oxidase inhibitor medication in the last month
- •have high or low thyroid function that has not been controlled in the normal range for at least 2 months
结局指标
主要结局
Percent fat after 16 weeks treatment using a Hologic QDR 4500 DEXA.
次要结局
- UCP-1 gene expression by quantitative RT-PCR
- fat mass, lean mass
- visceral adiposity by multi-slice CT scanning
- resting metabolic rate and thermic effect of a single dose of ephedrine and caffeine
- adipose tissue gene expression profiling using oligonucleotide array
研究者
Steven Smith
Associate Professor, Adjunct
Pennington Biomedical Research Center