EUCTR2015-001552-30-DK进行中（未招募）1 期
Effect of dapagliflozin, metformin and physical activity on glucose variability, body composition and cardiovascular risk in pre-diabetes (The PRE-D Trial) - A randomised, parallel, open-label, intervention study - Pre-D Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •HbA1c 6.0-6.4% (42-47 mmol/mol)
- •Age 35-70 years
- •BMI = 25 kg/m2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression
- •Treatment with hormones which affect glucose metabolism
- •Treatment with loop diuretics or thiazolidinediones
- •Treatment with beta blockers or peroral steroids
- •Bariatric surgery within the past 2 years
- •Impaired renal function defined as an estimated GFR<60 ml/min/1.73m2
- •Neurogenic bladderdisorders
- •Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion
- •Pegnant or lactating women
- •Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implantation hormonal vaginal ring, transdermal application, or intra-uterine devices
- •Allergic to one or more of the medications used in the study
- •Treatment with peroral steroids
- •Concomitant participation in other intervention study
- •Unable to understand the informed consent and the study procedures
研究者
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