Effects of Pioglitazone on Visceral Fat Metabolic Activity
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of treatment on the nominal change in FDG uptake of fat tissue from baseline after 16 weeks of treatment as measured by FDG-PET/CT imaging.
研究概览
简要总结
Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume, but it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate the effect of pioglitazone on glucose metabolism of fat tissue by using 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between the ages of 35 and 85 years
- •Subjects with impaired glucose tolerance and type 2 diabetes
排除标准
- •Subjects with insulin treatment
- •Subjects with uncontrolled diabetes, hypertension, symptomatic coronary artery disease, symptomatic cerebrovascular disease
- •Subjects taking more than three antidiabetic medications
- •Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones within 8 weeks prior to randomization
- •Subjects with cardiac failure (New York Heart Association Class > III) or left ventricular dysfunction (LVEF < 40%)
- •Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease
研究组 & 干预措施
Active Comparator: 1
up to 30 mg pioglitazone, tablet, orally, once daily
干预措施: Pioglitazone vs Glimepiride (Drug)
Sham Comparator: 1
up to 4 mg/day glimepiride, tablet, orally, once daily
干预措施: Pioglitazone vs Glimepiride (Drug)
结局指标
主要结局
Effect of treatment on the nominal change in FDG uptake of fat tissue from baseline after 16 weeks of treatment as measured by FDG-PET/CT imaging.
时间窗: Baseline and 16 weeks after treatment
次要结局
- Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers(Baseline and 16 weeks after treatment)