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|
|Actual Primary Completion Date :||June 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|