Understanding Diverse Contributors to Gestational Diabetes Mellitus and Its Near-to-Long Term Consequences: An Indiana University Grand Challenges Precision Health Initiative Cohort Study (The Hoosier Moms Cohort)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 411
- 试验地点
- 6
- 主要终点
- GDM Diagnosis
研究概览
简要总结
The Hoosier Moms Cohort (HMC) study's goal is to better understand the pathophysiology underlying the development of gestational diabetes mellitus (GDM) in pregnant women and its transition to Type 2 diabetes mellitus in mothers and their exposed children.
The HMC study wants to determine what biomarkers (genetic, blood based and behavioral/interventional) can be identified in pregnant women affected with GDM and how those biomarkers can be used to impact preventative care.
详细描述
Predictive GDM genetic risk models will be tested and refined in the Hoosier Moms Cohort. In addition to prospectively using genetic information to predict GDM risk, the Hoosier Moms Cohort will incorporate the use of wearable/digital devices for collection of detailed behavioral information, support development of novel dietary capture methods, and enable the collection of specimens specifically aimed at multiple 'omics' techniques to engage in a detailed, multidimensional assessment of pathophysiologic pathways and biomarkers.
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
- 是
入选标准
- •Singleton gestation
- •Gestational age ≤ 20+0 confirmed via American Congress of Obstetrics and Gynecology (ACOG) ultrasound dating guidelines
- •18 years old or greater at time of consent
排除标准
- •Pre pregnancy diagnosis of Type 1 Diabetes or Type 2 Diabetes or Screening Hemoglobin A1C that is greater than or equal to 6.5% or two abnormal values on a 3 hours Oral Glucose Tolerance Test (100g load) before 20 weeks gestation
- •Pre pregnancy chronic usage of systemic steroids (inhaled and short term usage acceptable)
- •Planned pregnancy termination
- •Unable to provide informed consent in English or Spanish
- •Major fetal anomalies as listed below that are known prior to enrollment. If these are discovered after enrollment, the participant may be allowed to participate, unless the discovered fetal anomaly is a lethal anomaly.
- •Major Fetal Anomalies to be Excluded:
- •Congenital diaphragmatic hernia
- •Congenital cystic adenomatoid malformation
- •Pleural effusions
- •Chylothorax
- •Bronchogenic cyst
- •Bronchopulmonary sequestration
- •Anomalous pulmonary venous return
- •Tricuspid atresia
- •Mitral atresia
- •Double right ventricle
- •Ebstein's malformation
- •Pulmonary atresia
- •Hypoplastic left heart syndrome
- •Aortic coarctation
- •Fetal arrhythmias (tachycardia or bradycardia)
- •Transposition of the great vessels
- •Tetrology of Fallot
- •Double outlet right ventricle
- •Aortic stenosis
- •Holoprosencephaly
- •Anencephaly
- •Dandy-Walker malformation or variant
- •Septo-optic dysplasia
- •Neural tube defect
- •Vein of Galen aneurysm
- •Bilateral renal agenesis
- •Cystic renal disease (polycystic or multicystic)
- •Any genitourinary lesion accompanied by oligohydramnios at <24 weeks
- •Obstructive uropathy
- •Horseshoe kidney
- •Megacystis microcolon
- •Achondrogenesis
- •Thanatophoric dysplasia
- •Thoracic dysplasia
- •Osteogenesis imperfect
- •Short rib polydactyly
- •Any skeletal defect associated with small thorax
- •Hypophosphatemia
- •Any karyotypic abnormality
- •Any suspected genetic syndrome
- •Cleft lip/palate
- •Micrognathia
- •Fetal anemia (<35% on cordocentesis)
- •Neck mass
- 另有 2 项未显示
结局指标
主要结局
GDM Diagnosis
时间窗: 42 weeks or less gestational age
Number of subjects diagnosed with GDM
次要结局
未报告次要终点
研究者
David Haas
Professor of Obstetrics & Gynecology
Indiana University