NCT00219440已完成4 期
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- glucose
研究概览
简要总结
We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.
详细描述
A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial
- ACTOS plus a standard diet
- ACTOS plus a portion-controlled diet
- Metformin plus a standard diet. The end-point of the trial is the change in body fat content from baseline to the end of the trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 35 to 75 who have type 2 diabetes mellitus
排除标准
- •Individuals with co-existing other diseases
结局指标
主要结局
glucose
时间窗: 4 months
次要结局
- Change in lipids(4 months)
- blood pressure(4 months)
研究者
George A. Bray
Professor, Adjunct
Pennington Biomedical Research Center
研究点 (2)
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