Change in Visceral Adipose Tissue Area From Baseline to 18 Months
| Group | Value (centimeters squared) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | -22 | 6 |
| Placebo | -4 | 4 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Active comparator
1
recombinant human growth hormone subcutaneously once a day
Placebo comparator
2
placebo subcutaneously once a day
Outcomes the sponsor listed as primary.
Change in Visceral Adipose Tissue Area From Baseline to 18 Months
Time frame · 18 months
change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan
Change in Insulin-like Growth Factor-I From Baseline to 18 Months
Time frame · 18 months
Change in insulin-like growth factor-1
Change in Trunk Fat
Time frame · 18 months
Change in Fasting Glucose
Time frame · 18 months
change in fasting glucose
Change in Trunk to Extremity Ratio
Time frame · 18 months
change in trunk to extremity ratio
Change in Triglycerides
Time frame · 18 months
Change in triglycerides
Change in Subcutaneous Adipose Tissue
Time frame · 18 months
Change in subcutaneous adipose tissue
Change in CD4 Cells
Time frame · 18 months
Change in CD4 cells
Change in Logarithm HIV Viral Load
Time frame · 18 months
Change in logarithm base 10 HIV viral load
Change in Lean Body Mass
Time frame · 18 months
change in lean body mass
Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months
Time frame · 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.
Change in Diastolic Blood Pressure
Time frame · 18 months
Change in diastolic blood pressure
Change in Adiponectin
Time frame · 18 months
Change in adiponectin
Change in Carotid Intima Media Thickness (IMT)
Time frame · 18 months
change in carotid intima media thickness (IMT)
Change in Body Mass Index
Time frame · 18 months
Change in body mass index
Change in Extremity Fat
Time frame · 18 months
Change in extremity fat
Change in 2-hour Glucose
Time frame · 18 months
Change in 2-hour glucose
Change in Systolic Blood Pressure
Time frame · 18 months
Change in systolic blood pressure
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (centimeters squared) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | -22 | 6 |
| Placebo | -4 | 4 |
| Group | Value (nanograms/milliliter) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | 109 | 11 |
| Placebo | -25 | 8 |
| Group | Value (kilograms) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | -0.5 | 0.2 |
| Placebo | 0.2 | 0.2 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | 6 | 1 |
| Placebo | 5 | 1 |
| Group | Value (kilogram per kilogram) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | -0.4 | 0.1 |
| Placebo | 0 | 0 |
| Group | Value (mg/dL) |
|---|---|
| Recombinant Human Growth Hormone | -7 |
| Placebo | 0 |
| Group | Value (centimeters squared) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | 4 | 4 |
| Placebo | 4 | 4 |
| Group | Value (cells/microliter) | Spread |
|---|---|---|
| Recombinant Human Growth Hormone | -19 | 13 |
| Placebo | 15 | 21 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Recombinant Human Growth Hormonerecombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously | – | 4 / 26 | 3 / 26 |
| Placeboplacebo subcutaneously once a day | – | 1 / 29 | 5 / 29 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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Studies that cite this trial.
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