Effects of Short-term Growth Hormone in HIV-infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
研究概览
简要总结
The purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity.
详细描述
The primary objective of this study is to determine the differential effects of growth hormone releasing hormone (GHRH) vs. low dose physiologic growth hormone (GH) vs. higher dose GH treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Subjects with HIV-infection will be randomized to receive one of three treatments: GHRH 2mg/day, or growth hormone 6mcg/kg/day (physiologic "low" dose), or growth hormone 2mg/day ("higher" dose) for 2 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 treatment 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previously diagnosed HIV infection
- •Stable antiretroviral regimen for at least 12 weeks prior to enrollment
- •Waist circumference >/= 95cm and waist-to-hip ratio >/= 0.94 for males or waist circumference >/=94cm and WHR >/= 0.88 for females, occurring in the context of treatment for HIV disease
- •Subjective evidence of at least one of the following changes, occurring during the treatment of HIV disease: increased abdominal girth, relative loss of fat in the extremities, or relative loss of fat in the face
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 releasing factor within six months of starting the study
- •Change in lipid lowering or antihypertensive regimen within 3 months of screening
- •Fasting blood sugar >126mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4 mg/dL, FSH > 20 IU/L in women, or CD4 count < 200
- •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 > 5ng/mL
- •Prior history of hypopituitarism, head irradiation, or any other condition known to affect the GH axis
- •positive beta-HCG (women only)
- •Oral contraceptives, depo provera, or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study
- •weight < 110 pounds
研究组 & 干预措施
GH 6mcg/kg/d
Recombinant human growth hormone 6mcg/kg SC once daily
干预措施: Growth hormone (Drug)
GH 2mg daily
Recombinant human growth hormone 2mg SC once daily
干预措施: Growth hormone (Drug)
Growth Hormone Releasing Hormone
Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
干预措施: Growth Hormone Releasing Hormone (Drug)
结局指标
主要结局
Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
时间窗: after 2 weeks treatment
Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.
次要结局
- Insulin Sensitivity(after two weeks treatment)
研究者
Steven K. Grinspoon, MD
Professor of Medicine
Massachusetts General Hospital