Phase 4
N=20
Metabolic Abnormalities in HIV-infected Persons
Lipodystrophy · HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT01612858 ↗Enrolled (actual)
20
Serious AEs
35.0%
Results posted
Jun 2016
Primary outcome: Primary: Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent — -0.25; -0.96 mg/kg lean body mass/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metformin (Drug); Pioglitazone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent |
-0.25; -0.96 | — |
| SECONDARY Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent |
2.30; -2.56 | — |
Summary
The purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body fat in this population.
Eligibility Criteria
Inclusion Criteria
- Age 18-70 years
- Fasting insulin >12 μU/mL and/or serum glucose between 140-200 mg/dl after 75 g 2hr oral glucose tolerance test
- Central fat deposition or Peripheral fat atrophy
- Fasting glucose ≤126 mg/dL
- BMI ≥18 and ≤35 kg/m2
- CD4 cell count ≥100 cells/mm3
- Stable antiretroviral regimen ≥12 weeks and HIV RNA 2.5x upper normal limit
- Alkaline phosphatase or prothrombin time >2x upper normal limit
- Serum creatinine >1.4 mg/dL
- History of congestive heart failure
- Hemoglobin <8 g/dL
- Alcohol abuse
- Pregnancy
- History of lactic acidosis
- Use of steroids
- Acute infection within last one month
- History of bladder cancer
Data sourced from ClinicalTrials.gov (NCT01612858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.