Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- HsCRP
研究概览
简要总结
This study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women and men. In women and men with increased abdominal weight, growth hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin resistance and body composition will be measured.
详细描述
The purpose of this study is to measure growth hormone levels in women and men who are normal weight, overweight, and obese. Growth hormone levels will be correlated with body weight, body composition, and markers of cardiovascular risk. In overweight or obese women and men with increased visceral adiposity and below average IGF-1 levels, growth hormone versus placebo will be given for 6 months. Effects of growth hormone treatment on weight, body composition, insulin resistance, lipids, and cardiovascular risk markers will then be assessed. Study subjects will be followed for an additional six months for these endpoints.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For growth hormone measurement part (for men and women):
- •For visceral adiposity arm: waist circumference greater than or equal to 88 cm for women or 102 cm for men, and BMI greater than or equal to 25 kg/m2
- •For lean controls: BMI 18.5 to 24.9 kg/m2
- •For growth hormone treatment part (for men and women):
- •Visceral adiposity (waist circumference greater than or equal to 88 cm for women and 102 for men, BMI greater than or equal to 25 kg/m2)
- •IGF-I within the lowest 2 quartiles for age and gender
- •Willingness to maintain current activity level and diet
排除标准
- •Diabetes mellitus (fasting plasma glucose greater than 126 mg/dL or 2-hour post-oral glucose tolerance test [OGTT] plasma glucose greater than 200)
- •Taking the following medications in the last 3 months: weight loss or lipid-lowering agents, medications to treat diabetes mellitus or "pre-diabetes", oral contraceptives or estrogen-containing medications, other medications known to significantly affect weight
- •Hematocrit below the lower limit of normal
- •Amenorrhea for 3 months (in women)
- •Pregnant or breastfeeding (in women)
- •Polycystic ovary syndrome (in women)
- •Weight that exceeds 280 pounds
- •SGPT greater than 2 times the upper limit of normal
- •History of malignancy, except for fully resolved basal cell carcinomas of the skin (Specific Aim 2 only)
- •Radiation exposure greater than 1000 mrem over the last 12 months
- •Previous diagnosis of cardiovascular disease
- •History of pituitary or hypothalamic disease, brain radiation, or childhood growth hormone deficiency
- •History of carpal tunnel syndrome that has not been surgically treated
研究组 & 干预措施
Male on GH
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
干预措施: Nutropin AQ growth hormone (Drug)
Male on Placebo
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
干预措施: Placebo Growth Hormone (Drug)
Female on GH
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
干预措施: Nutropin AQ growth hormone (Drug)
Female on Placebo
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
干预措施: Placebo Growth Hormone (Drug)
结局指标
主要结局
HsCRP
时间窗: Measured at baseline and month 6
6 month change in HsCRP (primary cardiovascular risk endpoint)
Total Abdominal Fat
时间窗: Measured at baseline and month 6
6 month change in total abdominal fat (primary body composition endpoint)
Abdominal Fat
时间窗: Measured at baseline and month 6
6 month change in visceral abdominal fat (primary body composition endpoint)
次要结局
- Measure of Insulin Resistance(Measured at baseline and month 6)
- Insulin-like Growth Factor-1 (IGF-1) Levels(Measured at baseline and month 6)
研究者
Karen Klahr Miller, MD
Associate Professor of Medicine
Massachusetts General Hospital