Effects of IGF-I in HIV Metabolic Disease
|ClinicalTrials.gov Identifier: NCT01329744|
Recruitment Status : Terminated
First Posted : April 6, 2011
Last Update Posted : March 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Lipodystrophy||Drug: mecasermin Drug: Placebo control||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Recombinant IGF-I in HIV Associated Metabolic Disease|
|Study Start Date :||June 2011|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
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
- Body composition [ Time Frame: 24 weeks ]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 ]Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|