Towards Precision Medicine for Diabetes in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- glucose-disposition-index
研究概览
简要总结
Rationale: Gestational diabetes is currently treated by the one-size-fits-all-approach. Treatment efficacy is poorly defined and inconsiderate of patients clinical presentation Objective: To characterize the efficacy of pharmacological treatment of gestational diabetes mellitus between patients with distinct metabolic phenotypes Study design: Prospective observational study, in metformin-treatment efficacy is compared between patients with GDM caused by insulin resistance and patients with GDM caused by low insulin secretion.
Study population: A prospective cohort of 103 women with diagnosed gestational diabetes mellitus treated by metformin.
Main study parameters/endpoints: Primary outcomes is the glucose-disposition-index in late pregnancy (35-37 weeks gestation) and requirement for supplemental insulin-treatment. Secondary outcomes include insulin sensitivity (Matsuda-index), insulin secretion (Stumvoll-index), HbA1c, gestational weight gain, body composition, physical activity, eating behavior, plasma biomarkers, glucose control, and maternal and infant pregnancy outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •having a confirmed single, viable pregnancy past 20 weeks gestation.
- •assigned to pharmacological (ie metformin) treatment for GDM.
排除标准
- •pre-existing diabetes, hypertension (SBP >160 mmHg & DBP >110 mmHg)
- •using medication related to study outcomes prior to GDM diagnosis (insulin, metformin, glyburide, systemic steroids, mood stabilizers, ADHD medication)
- •smoking or using recreational drugs that may affect pregnancy outcomes
研究组 & 干预措施
Low insulin sensitivity
Women will be classified as having low insulin sensitivity, if their Matsuda-index is in the lowest quartile of a reference cohort
干预措施: Metformin (Drug)
Low insulin secretion
Women will be classified as having low insulin secretion if their Stumvoll-index is in the lowest quartile of a reference cohort
干预措施: Metformin (Drug)
结局指标
主要结局
glucose-disposition-index
时间窗: 35-37 weeks gestation
glucose-disposition-index is calculated as product of Stumvoll- and Matsuda-index, assessed during a 75g-oral glucose tolerance test,
次要结局
- Dietary intake(24-28 and 35-37 weeks gestation)
- Glucose control(24-28 and 35-37 weeks gestation)
- Delivery complications(Birth)
- Neonatal body weight(at birth, and at 6 weeks of age)
- Neonatal body length(at birth, and at 6 weeks of age)
- Insulin treatment(35-37 weeks gestation)
- HbA1c(24-28 and 35-37 weeks gestation)
- Body weight(24-28 and 35-37 weeks gestation)
- Body fat mass(24-28 and 35-37 weeks gestation)
- Physical Activity(24-28 and 35-37 weeks gestation)