Effects of IGF-I in HIV Metabolic Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Recombinant IGF-I in HIV Associated Metabolic Disease|
- Body composition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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.
- Glucose Homeostasis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
a subcutaneous injection twice a day
Other Name: Increlex
|Placebo Comparator: Placebo||
Drug: Placebo control
Subcutaneous injection given twice per day of placebo compound, for 24 weeks
The main objectives of this study are the following:
- Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome.
- Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy.
- Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329744
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Roy J Kim, MD, MPH||UT Southwestern Medical Center|