NCT00737347已完成3 期
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- change in body weight
研究概览
简要总结
The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.
详细描述
The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater
排除标准
- •insulin treated
研究组 & 干预措施
1
No Intervention
usual care. Subjects had one 90 minute visit with registered dietitian
2.
Active Comparator
Standard care. Subjects had 4 sessions with registered dietitian
干预措施: Lifestyle modification (Behavioral)
3
Active Comparator
Intensive care. subjects had 10 visits with registered dietitian
干预措施: Lifestyle modification (Behavioral)
结局指标
主要结局
change in body weight
时间窗: 24 weeks
次要结局
- change in body composition(24 weeks)
研究者
研究点 (1)
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