NCT00629213已完成3 期
Metabolic Syndrome and Its Single Traits as Risk Factors of Diabetes in People With Impaired Glucose Tolerance: The STOP-NIDDM Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 1,429
- 试验地点
- 1
- 主要终点
- Incidence of newly diagnosed type 2 diabetes
研究概览
简要总结
The aim of the study was to analyse the independent and joint effects of the components of the metabolic syndrome (MetS) on the incidence of diabetes in people with impaired glucose tolerance (IGT) and to assess the effect of acarbose by MetS status.
Double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. MetS by ATP III definition with fasting plasma glucose of ≥ 6.1 mmol/l as limit for impaired fasting glucose (IFG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk population
- •Age 40 to 70 yrs.
- •BMI > 25 and < 40; FPG >5.5 mmol/l and < 7.8 mmol/l; IGT in OGGT
排除标准
- •Known type 2 diabetes
- •Drug intake affecting glucose tolerance
- •Any cardiovascular events within the last 6 months
研究组 & 干预措施
1
Active Comparator
干预措施: acarbose (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of newly diagnosed type 2 diabetes
次要结局
- newly diagnosed hypertension
研究者
研究点 (1)
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