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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months
placebo subcutaneously once a day, 18 months
MGH
Boston, Massachusetts, United States
Change in Visceral Adipose Tissue Area From Baseline to 18 Months
change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan
Time frame: 18 months
Change in Insulin-like Growth Factor-I From Baseline to 18 Months
Change in insulin-like growth factor-1
Time frame: 18 months
Change in Trunk Fat
Time frame: 18 months
Change in Fasting Glucose
change in fasting glucose
Time frame: 18 months
Change in Trunk to Extremity Ratio
change in trunk to extremity ratio
Time frame: 18 months
Change in Triglycerides
Change in triglycerides
Time frame: 18 months
Change in Subcutaneous Adipose Tissue
Change in subcutaneous adipose tissue
Time frame: 18 months
Change in CD4 Cells
Change in CD4 cells
Time frame: 18 months
Change in Logarithm HIV Viral Load
Change in logarithm base 10 HIV viral load
Time frame: 18 months
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Change in Lean Body Mass
change in lean body mass
Time frame: 18 months
Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months
Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.
Time frame: 18 months
Change in Diastolic Blood Pressure
Change in diastolic blood pressure
Time frame: 18 months
Change in Adiponectin
Change in adiponectin
Time frame: 18 months
Change in Carotid Intima Media Thickness (IMT)
change in carotid intima media thickness (IMT)
Time frame: 18 months
Change in Body Mass Index
Change in body mass index
Time frame: 18 months
Change in Extremity Fat
Change in extremity fat
Time frame: 18 months
Change in 2-hour Glucose
Change in 2-hour glucose
Time frame: 18 months
Change in Systolic Blood Pressure
Change in systolic blood pressure
Time frame: 18 months