Brief Title
Effects of IGF-I in HIV Metabolic Disease
Official Title
Effects of Recombinant IGF-I in HIV Associated Metabolic Disease
Brief Summary
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.
Detailed Description
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Body composition
Secondary Outcome
Glucose Homeostasis
Condition
HIV Lipodystrophy
Intervention
mecasermin
Study Arms / Comparison Groups
Treatment
Description: Recombinant IGF-I
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
16
Start Date
June 2011
Completion Date
June 2013
Primary Completion Date
June 2013
Eligibility Criteria
Inclusion Criteria: - HIV positive with undetectable viral load - No change in antiretrovirals for 3 months - Evidence of lipoatrophy in the limbs, and face or gluteal area - Dyslipidemia defined as: - Fasting triglycerides > 200 OR - HDL cholesterol < 40 mg/dL - Abnormal glucose homeostasis defined as: - Fasting hyperinsulinemia > 20 uU/mL OR - Fasting glucose 100-125 mg/dL, inclusive Exclusion Criteria: - Two consecutive viral >75 or > 50 copies/mL using the tests listed above - Presence of AIDS wasting - Change in antiretroviral medication (not dose) in the prior 3 months - Coronary artery disease, cerebrovascular, or peripheral arterial disease - Diabetes mellitus - Adrenal insufficiency, hypoglycemia, thyroid disease, or other endocrine disorder that is untreated - Malignancy - Eating disorder - Pregnancy (urine pregnancy test is required of all females) - Previous liposuction or bariatric surgery - Other systemic conditions or other disorders at the discretion of the investigators - Current use of systemic glucocorticoids, or other agent affecting body weight or glucose homeostasis or other drug at the discretion of the investigators - Use of interferon within the past six months - Use of insulin, insulin secretagogue, thiazolidinedione, or metformin in the prior 3 months - Initiation or dose adjustment, within the prior 3 months, of any of the following drugs or drug classes: fibrate, cholesterol binding resin, statin, niacin, or omega 3 fatty acid (fish oil). - Use of uridine, growth hormone, IGF-I, and growth hormone releasing factor analogues
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Roy J Kim, MD, MPH, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01329744
Organization ID
1K23DK080644-01A1
Responsible Party
Principal Investigator
Study Sponsor
University of Texas Southwestern Medical Center
Study Sponsor
Roy J Kim, MD, MPH, Principal Investigator, UT Southwestern Medical Center
Verification Date
March 2016