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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- Indiana University
- Enrollment
- 411
- Locations
- 6
- Primary Endpoint
- GDM Diagnosis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
David Haas
Professor of Obstetrics & Gynecology
Indiana University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
GDM Diagnosis
Time Frame: 42 weeks or less gestational age
Number of subjects diagnosed with GDM