Metabolic Abnormalities in HIV-infected Persons
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Metformin
干预措施: Metformin (Drug)
Pioglitazone
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent
时间窗: 3 months
Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone
次要结局
- Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent(12 weeks)