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Effects of IGF-I in HIV Metabolic Disease

This study is currently recruiting participants.
Verified March 2012 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
Roy Kim, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01329744
First received: April 4, 2011
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Lipodystrophy
 Drug: mecasermin
Drug: Placebo control
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 48
Study Start Date: June 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Recombinant IGF-I
 Drug: mecasermin
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329744

Contacts
Contact: Roy J Kim, MD, MPH 214-648-3501 roy.kim@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Roy Kim, MD, MPH     214-648-9193     roy.kim@utsouthwestern.e_d_u    
Principal Investigator: Roy Kim, MD, MPH            
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Roy J Kim, MD, MPH UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Roy Kim, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01329744     History of Changes
Other Study ID Numbers: 1K23DK080644-01A1
Study First Received: April 4, 2011
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
HIV lipodystrophy

Additional relevant MeSH terms:
Lipodystrophy
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 22, 2013