Metabolic Abnormalities in HIV-infected Persons
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| ClinicalTrials.gov Identifier: NCT01612858 |
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Recruitment Status
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Completed
First Posted
: June 6, 2012
Results First Posted
: June 20, 2016
Last Update Posted
: June 20, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lipodystrophy HIV Infection | Drug: Metformin Drug: Pioglitazone | Phase 4 |
Although HIV antiretroviral medications have helped patients live longer, they have also been associated with side effects including insulin resistance and changes in body fat distribution. Changes in body fat distribution associated with HIV antiretroviral medications may result in increased fat in the abdomen, neck, and upper back, which is often called central fat deposition. HIV antiretroviral medications may also result in loss of fat in legs, arms, and face, which is often called peripheral fat atrophy.
This study will obtain preliminary data on the effect of 12 weeks of metformin on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and central fat deposition. Similarly, this study will obtain preliminary data on the effect of 12 weeks of pioglitazone on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and peripheral fat atrophy.
This study involves taking a drug that has been approved by the U.S. Food and Drug Administration (FDA) for use in humans for a period of 3 months.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Metabolic Abnormalities in HIV-infected Persons |
| Study Start Date : | June 2011 |
| Actual Primary Completion Date : | November 2014 |
| Actual Study Completion Date : | November 2014 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Metformin |
Drug: Metformin
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.
Other Names:
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| Experimental: Pioglitazone |
Drug: Pioglitazone
Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
Other Name: Actos
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- Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent [ Time Frame: 3 months ]Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone
- Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent [ Time Frame: 12 weeks ]Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 <1000 copies
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612858
| United States, Massachusetts | |
| Tufts Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: | Rakhi Kohli, MD, MS | Tufts Medical Center |
| Responsible Party: | Tufts Medical Center |
| ClinicalTrials.gov Identifier: | NCT01612858 History of Changes |
| Other Study ID Numbers: |
CLAMP-K23 1K23DK079789-01A2 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 6, 2012 Key Record Dates |
| Results First Posted: | June 20, 2016 |
| Last Update Posted: | June 20, 2016 |
| Last Verified: | May 2016 |
Keywords provided by Tufts Medical Center:
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Lipodystrophy Insulin resistance HIV infection |
Additional relevant MeSH terms:
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HIV Infections Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Pioglitazone Metformin Hypoglycemic Agents Physiological Effects of Drugs |