Mechanism of Growth Hormone Effects on Adipose Tissue
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- energy expenditure at baseline, after 6 months of treatment and at the end of the followup period
研究概览
简要总结
Growth hormone treatment in humans has been shown to decrease body fat. This study aims to determine what adipose tissue depots are affected by GH and what is the mechanism.
详细描述
Growth hormone (GH) replacement in GH deficient adults results in an improvement in metabolic status, an increase in lean body mass and a reduction in visceral adiposity. GH might also decrease visceral adiposity in obese adults that are not GH deficient.
The objective of the study is to determine the effects of GH on the metabolic syndrome and visceral adiposity in men with low blood levels of IGF-1 and the durability of these effects after stopping GH therapy. We will use a double blind, placebo controlled 6 month intervention trial followed by a blinded follow-up period of 6 months. Thirty non-diabetic middle aged men with central adiposity (BMI > 27 kg/m2, waist circumference > 102 cm) will participate.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 40-70
- •Central obesity defined as waist circumference greater than 102 cm and BMI > 27 and < 35 kg/m2
- •No weight loss in last 12 months
- •Total IGF-1 level < 241 ng/ml (~25th percentile for the assay)
- •Body habitus which permitted accurate CT scan acquisition and analysis.
排除标准
- •Significant neurologic, metabolic, endocrine, cardiac, respiratory or gastrointestinal disease
- •Known coronary heart disease
- •Exercised more than 3 hours per week
- •Unwilling or unable to abstain from alcohol for 72 hours prior to the measurements of energy expenditure and fasting blood work
结局指标
主要结局
energy expenditure at baseline, after 6 months of treatment and at the end of the followup period
body composition at baseline, after 6 months of treatment and at the end of the followup period
次要结局
- gene expression in adipose tissue at baseline and after 6 months of treatment
研究者
Frank Greenway
Clinical Medical Doctor
Pennington Biomedical Research Center