Physiologic Growth Hormone Effects in HIV Lipodystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Visceral Adipose Tissue Area From Baseline to 18 Months
研究概览
简要总结
This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.
详细描述
This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat preferentially over subcutaneous fat, and increase lean body mass. Secondary endpoints will include measures of IGF-1, glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters. Dosing of growth hormone will be based on patients' IGF-1 levels and will not exceed 6mcg/kg/day.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women age 18-60
- •Previously diagnosed HIV infection
- •Stable antiviral regimen for at least 12 weeks prior to enrollment
- •Waist-to-hip ratio >0.90 for men and >0.85 for women
- •Evidence of at least one of the following recent changes: *increased abdominal girth,
- •*relative loss of fat in the extremities, *relative loss of fat in the face
- •Simulated peak GH response to arginine/GHRH of less than 7.5 mcg/dL
排除标准
- •Use of Megace, anti-diabetic agents, GH, or other anabolic agents, pharmacologic glucocorticoid (prednisone >5 mg/day or its equivalent) for 3 months prior to enrollment. Patients on a standard dose of testosterone for documented hypogonadism will be allowed to enter the protocol. Women taking standard estrogen replacement therapy for >3 months will be allowed in the study.
- •Diabetes mellitus
- •Other severe chronic illness
- •HgB <9.0 g/dL, creatinine >1.4 mg/dL, or PSA >4 ng/mL
- •Positive BHCG or failure to use appropriate birth control during study. Acceptable methods include oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, IUD's, barrier devices (condoms, diaphragms), and abstinence.
- •Carpal tunnel syndrome
- •Active malignancy or history of pituitary malignancy, history of colon cancer or prostate malignancy
研究组 & 干预措施
1
recombinant human growth hormone subcutaneously once a day
干预措施: recombinant human growth hormone (Drug)
2
placebo subcutaneously once a day
干预措施: placebo (Drug)
结局指标
主要结局
Change in Visceral Adipose Tissue Area From Baseline to 18 Months
时间窗: 18 months
change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan
次要结局
- Change in Insulin-like Growth Factor-I From Baseline to 18 Months(18 months)
- Change in Logarithm HIV Viral Load(18 months)
- Change in Lean Body Mass(18 months)
- Change in Trunk Fat(18 months)
- Change in Fasting Glucose(18 months)
- Change in Trunk to Extremity Ratio(18 months)
- Change in Triglycerides(18 months)
- Change in Subcutaneous Adipose Tissue(18 months)
- Change in CD4 Cells(18 months)
- Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months(18 months)
- Change in Diastolic Blood Pressure(18 months)
- Change in Adiponectin(18 months)
- Change in Systolic Blood Pressure(18 months)
- Change in Carotid Intima Media Thickness (IMT)(18 months)
- Change in Body Mass Index(18 months)
- Change in Extremity Fat(18 months)
- Change in 2-hour Glucose(18 months)