DRKS00020453已完成未知
Pilot study for individualized remission induction of type 2 diabetes - PiREM
Klinikum der Universität München, Campus Innenstadt0 个研究点目标入组 8 人开始时间: 2020年1月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •T2D diagnosed within the last 6 years. T2D diagnosis confirmed by at least two different tests [HbA1c = 6.5% and (fasting glucose = 126 mg/dl or random glucose = 200 mg/dl or 2-h glucose in an oral glucose tolerance test = 200 mg/dl)]
- •Diabetic continuous glucose profile at study inclusion (at least two timepoints with fasting sensor glucose = 126 mg/dl or any sensor glucose value = 200 mg/dl; interruption of the antidiabetic medication, if necessary, for 1-7 days)
- •Written informed consent
排除标准
- •Other diabetes type than type 2
- •Pregnancy or planned pregnancy in the following 12 months
- •Planned surgery in the following 12 months
- •eGFR < 30 ml/min/1.73 m²
- •Myocardial infarction or stroke within the last 6 months
- •Heart failure = NYHA 2
- •Previous or planned bariatric surgery
- •Psychiatric disorder requiring inpatient treatment within the last 12 months
- •Alcohol abuse or use of illegal drugs
- •Other disease that prevents participation in the planned lifestyle intervention
- •Participation in another clinical trial
研究者
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