NCT07263412招募中不适用
A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年2月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Improvement Rate of Glucose Metabolism During the Perinatal Period
研究概览
简要总结
A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All must be met
- •Aged 18-40 years;
- •Pre-pregnancy BMI: 18.5 kg/m² < BMI < 28 kg/m²;
- •Able to read, understand and sign the informed consent form;
- •Receive prenatal care and deliver in the study hospital.
排除标准
- •Any one met leads to exclusion
- •Twin or multiple pregnancies;
- •Pre-gestational diabetes mellitus (PGDM), including new-onset diabetes during pregnancy;
- •Poorly controlled pre-pregnancy chronic hypertension (BP ≥140/90 mmHg);
- •Complicated with severe liver/kidney diseases;
- •Current/recent use of drugs affecting glucose metabolism;
- •Mental illness or severe psychological disorders;
- •Complicated with severe infection;
- •Poor compliance or refusal to use CGM/SMBG.
结局指标
主要结局
Improvement Rate of Glucose Metabolism During the Perinatal Period
时间窗: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum.
次要结局
- Improvement Rate of Glucose Metabolism in GDM Pregnant Women After Intervention(From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum)
- Long-term Incidence of Cardiovascular Disease (CVD)(From 6 months postpartum to 2 years postpartum)
- Long-term Incidence of Type 2 Diabetes Mellitus (T2DM)(From 6 months postpartum to 2 years postpartum)
- Incidence of Adverse Outcomes(From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum)
- Abnormal Blood Glucose Status in Offspring(From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth))
- Obesity Rate in Offspring(From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth))
研究者
研究点 (1)
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