Metabolic Abnormalities in HIV-infected Persons
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
June 20, 2016
CompletedJune 20, 2016
May 1, 2016
3.4 years
June 4, 2012
May 12, 2016
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent
Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone
3 months
Secondary Outcomes (1)
Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent
12 weeks
Study Arms (2)
Metformin
EXPERIMENTALPioglitazone
EXPERIMENTALInterventions
Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
Eligibility Criteria
You may qualify if:
- 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 \<1000 copies
You may not qualify if:
- Diabetes mellitus
- Cardiac pacemaker or metal implant
- Liver enzymes \>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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tufts Medical Center
Boston, Massachusetts, 02111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rakhi Kohli MD MS
- Organization
- Tufts Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Rakhi Kohli, MD, MS
Tufts Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 6, 2012
Study Start
June 1, 2011
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
June 20, 2016
Results First Posted
June 20, 2016
Record last verified: 2016-05