- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01329744
Effects of IGF-I in HIV Metabolic Disease
March 22, 2016 updated by: Roy Kim, University of Texas Southwestern Medical Center
Effects of Recombinant IGF-I in HIV Associated 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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Subcutaneous injection given twice per day of placebo compound, for 24 weeks
|
Experimental: Treatment
Recombinant IGF-I
|
a subcutaneous injection twice a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Homeostasis
Time Frame: 24 weeks
|
Fasting glucose and insulin will be measured.
A subset of patients will undergo a hyperinsulinemic clamp.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Roy J Kim, MD, MPH, UT Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
April 4, 2011
First Submitted That Met QC Criteria
April 5, 2011
First Posted (Estimate)
April 6, 2011
Study Record Updates
Last Update Posted (Estimate)
March 23, 2016
Last Update Submitted That Met QC Criteria
March 22, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1K23DK080644-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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