Metabolic Abnormalities in HIV-infected Persons (CLAMP)
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Purpose
This purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study seeks to measure insulin sensitivity in HIV-infected persons with a gold-standard test, and seeks to determine the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and fat in this population.
| Condition | Intervention | Phase |
|---|---|---|
|
Lipodystrophy HIV Infection |
Drug: Metformin Drug: Pioglitazone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Metabolic Abnormalities in HIV-infected Persons |
- Insulin sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Lipid content [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
| 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
|
Detailed Description:
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.
Insulin resistance is a pre-disease condition that often leads to diabetes after 10 to 20 years. Insulin is a hormone made by the body that tells the body to store glucose in muscle and fat. People with insulin resistance often need more insulin to store the same amount of glucose. Both insulin resistance and changes in fat distribution in HIV-infected persons are areas of active research because they are both associated with an increased risk of heart disease.
This study examines the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study will recruit both HIV-infected and uninfected persons. The investigators will compare findings between HIV-infected persons with central fat deposition and HIV-infected persons with peripheral fat atrophy, as well as between HIV-infected and uninfected persons.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18-60 years
- Fasting insulin ≥15 μU/mL and/or serum glucose between 140-200 mg/dL after 75 g 2hr OGTT
- 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
Contacts and Locations| Contact: Aretha Ren, BA | 617-636-5439 | aren@tuftsmedicalcenter.org |
| United States, Massachusetts | |
| Tufts Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: Rakhi Kohli, MD, MS | |
| Principal Investigator: | Rakhi Kohli, MD, MS | Tufts Medical Center |
More Information
No publications provided
| Responsible Party: | Tufts Medical Center |
| ClinicalTrials.gov Identifier: | NCT01612858 History of Changes |
| Other Study ID Numbers: | CLAMP-K23, 1K23DK079789-01A2 |
| Study First Received: | June 4, 2012 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board United States: Data and Safety Monitoring Board |
Keywords provided by Tufts Medical Center:
|
Lipodystrophy Insulin resistance HIV infection |
Additional relevant MeSH terms:
|
Congenital Abnormalities HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Pioglitazone Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 07, 2013
