Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Mean Overnight Growth Hormone
研究概览
简要总结
The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.
详细描述
The primary objective of this study is to determine the effects of growth hormone releasing hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg Tesamorelin, subcutaneously, daily for two weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the Tesamorelin and will return for an identical assessment after a 2 week withdrawal period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 18-60 years
- •BMI > 20kg/m2 and <35kg/m2
排除标准
- •Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study
- •Use of GH or growth hormone stimulating peptides within six months of starting the study
- •Change in lipid lowering or antihypertensive regimen within 3 months of screening
- •Fasting blood sugar > 126 mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4 mg/dL
- •Carpal tunnel syndrome
- •Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
- •For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5 ng/mL
- •Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
- •Weight < 110 lbs.
研究组 & 干预措施
Growth Hormone Releasing Hormone
Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
干预措施: Growth Hormone Releasing Hormone (Tesamorelin) (Drug)
结局指标
主要结局
Mean Overnight Growth Hormone
时间窗: at 2 weeks (i.e., after 2 weeks of treatment)
Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.
次要结局
- Insulin Stimulated Glucose Utilization(at 2 weeks (i.e., after 2 weeks of treatment))