EUCTR2013-000789-13-BE进行中（未招募）1 期
DALI: Vitamin D And Lifestyle Intervention for Gestational Diabetes Mellitus (GDM) Prevention - A European multicentre, randomised trial - DALI
VU University Medical Center0 个研究点目标入组 154 人开始时间: 2013年7月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
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
- 性别
- Female
入选标准
- •pre-pregnancy BMI (self-reported weight, measured height) is = 29 kg/m2)
- •aged 18 years or more
- •singleton pregnancy
- •gestational age at recruitment < 17 weeks
- •sufficiently fluent in major language of the country of recruitment
- •being able to be moderately physically active
- •giving written informed consent
- •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 880
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •preexisting diabetes
- •Diagnosed with (gestational) diabetes mellitus before randomisation defined as fasting glucose = 5.1 mmol/l and/or 1 hour glucose = 10 mmol/l and/or 2 hour glucose =8.5 mmol/l at baseline measurement.
- •not able to walk at least 100 meters safely
- •requirement for complex diets
- •advanced chronic conditions (e.g. valvular heart disease)
- •significant psychiatric disease
- •unable to speak major language of the country of recruitment fluently
研究者
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