NCT01964703已完成4 期
Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- serum glucose (fasting and post 75g oral glucose tolerance test)
研究概览
简要总结
The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years of age or older
- •prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl)
排除标准
- •pregnant women
- •taking anti-hyperglycemic agents within 3 months at the time of enrollment
- •history of heart failure, myocardial infarction, cerebral infarction
- •uncontrolled hypertension (systolic BP > 160mmHg, or diastolic BP > 100mmHg)
- •serum triglyceride level > 500mg/dl
- •kidney dysfunction (serum Creatinine > 30% of upper normal limits)
- •hepatic dysfunction (AST, ALT > 3 times of upper normal limits)
- •taking systemic glucocorticoids within 1 month
研究组 & 干预措施
Rubus occidentalis extract 900mg
Active Comparator
taking Rubus occidentalis extract 900mg/day for 12weeks
干预措施: Rubus occidentalis extract (Drug)
Rubus occidentalis extract 1800mg
Active Comparator
taking Rubus occidentalis extract 1800mg/day for 12weeks
干预措施: Rubus occidentalis extract (Drug)
结局指标
主要结局
serum glucose (fasting and post 75g oral glucose tolerance test)
时间窗: 12 weeks
次要结局
- serum insulin(12 weeks)
研究者
Sin Gon Kim
Professor
Korea University Anam Hospital
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