This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.
The main objectives of this study are the following: 1. Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome. 2. Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy. 3. Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
a subcutaneous injection twice a day
Subcutaneous injection given twice per day of placebo compound, for 24 weeks
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Body composition
Participants will have a body scan called a dual energy x-ray absorptiometry (DEXA) scan and a single slice abdominal CT scan and mid thigh scan to measure subcutaneous and internal fat.
Time frame: 24 weeks
Glucose Homeostasis
Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.
Time frame: 24 weeks
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