Understanding the Effects of Gestational Diabetes on Mother and Baby
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Maternal metabolic and cardiometabolic phenotype: blood pressure
研究概览
简要总结
Gestational diabetes mellitus (GDM) is a common pregnancy complication characterized by impaired glucose metabolism and increased insulin resistance. GDM is associated with adverse pregnancy outcomes and an increased long-term risk of metabolic and cardiovascular disease for both mother and offspring.
This prospective observational cohort study aims to establish a longitudinal pregnancy and birth cohort of women diagnosed with GDM. Pregnant women with a positive 75 g oral glucose tolerance test (OGTT) between gestational weeks 24 and 28 will be recruited after diagnosis and followed through late pregnancy, delivery, and early postpartum.
Participants will undergo two study visits during pregnancy, sample collection at delivery, and one postpartum visit 8-12 weeks after birth. Clinical data, physical measurements, questionnaire-based information, and biological samples will be collected from mothers and infants to enable comprehensive phenotyping of GDM pregnancies.
Data and biosamples from this cohort will be used for descriptive and hypothesis-driven analyses and may be compared with data from an existing longitudinal cohort of healthy pregnancies to support interpretation of GDM-related changes.
详细描述
Gestational diabetes mellitus (GDM) develops when physiological insulin resistance during pregnancy exceeds adaptive capacity, resulting in impaired glucose regulation. GDM is associated with increased perinatal morbidity and elevated long-term risk for metabolic and cardiovascular disease in both mothers and offspring. Despite its clinical relevance, the biological mechanisms underlying GDM and its long-term consequences are incompletely understood.
This prospective, monocentric observational cohort study is designed to establish a well-characterized longitudinal pregnancy and birth cohort of women diagnosed with GDM. The primary objective is to collect clinical data and biological samples across pregnancy, delivery, and early postpartum to support detailed phenotyping of GDM pregnancies and early-life outcomes.
Approximately 100 pregnant women with a confirmed diagnosis of GDM will be recruited per year at the Department of Obstetrics and Gynecology. Eligible participants are women aged 18 years or older with an ongoing pregnancy prior to gestational week 32 and a positive 75 g OGTT performed as part of routine clinical care. Women with major fetal anomalies are excluded.
Study participation includes four time points: 1.) a visit following GDM diagnosis (approximately gestational weeks 26-30), 2.) a late pregnancy visit (approximately weeks 34-37), 3.) sample and clinical data collection at delivery, and 4) a postpartum follow-up visit 8-12 weeks after birth.
At each study visit, standardized clinical assessments, physical measurements, and questionnaire-based information will be collected. Maternal assessments include anthropometry, body composition, blood pressure, and selected non-invasive cardiovascular and metabolic measurements. Fetal growth is assessed by routine obstetric ultrasound. At delivery, perinatal samples such as placenta, umbilical cord, and cord blood are collected. Postnatal assessments include maternal and infant anthropometry and selected cardiovascular measurements where applicable.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ongoing pregnancy prior to the 32nd gestational week and a positive GDM screening
排除标准
- •gestational age 32nd gestational week
- •fetal genetic anomalies /malformation
结局指标
主要结局
Maternal metabolic and cardiometabolic phenotype: blood pressure
时间窗: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Resting systolic and diastolic blood pressure measured using standardized clinical procedures after gestational diabetes diagnosis and during early postpartum follow-up.
Maternal metabolic and cardiometabolic phenotype: Adiposity
时间窗: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Measured as fat mass and fat-free mass by air displacement plethysmography longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
Maternal metabolic and cardiometabolic phenotype: fasting glucose
时间窗: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Fasting blood glucose as measured in mg/mL from NaF blood tubes longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
Maternal metabolic and cardiometabolic phenotype: cytokine profile
时间窗: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Serum cytokine will be analysed by multiplexing after gestational diabetes diagnosis and during early postpartum follow-up.
Maternal metabolic and cardiometabolic phenotype: lipid profile (triglycerides, phospholipids, free, fatty acids, HDL/LDL/total cholesterol)
时间窗: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Lipid profiles are measured after gestational diabetes diagnosis and during early postpartum follow-up.
Maternal metabolic and cardiometabolic phenotype: endothelial function
时间窗: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Endothelial function measured as pulse wave velocity using a Vicorder® after gestational diabetes diagnosis and during early postpartum follow-up.
Infant outcomes: adiposity
时间窗: At birth and at 8-12 weeks postpartum.
Measured as fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)
Infant outcomes: Neonatal C-peptide in cord blood
时间窗: At birth
Concentrations of C-peptide in cord blood serum
Infant outcomes: Neonatal glucose in cord blood
时间窗: At birth
Concentrations of glucose in cord blood serum
次要结局
未报告次要终点