The Hoosier Moms Cohort

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Related Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IU Health Methodist Hospital, Indianapolis, Indiana, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
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
Hydrops
Fetal anemia (<35% on cordocentesis)
Neck mass
Gastroschisis
Omphalocele

Treatment and study plan

Primary outcomes

GDM Diagnosis

Time frame: 42 weeks or less gestational age

Number of subjects diagnosed with GDM

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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)

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Oct 4, 2018
Registry last updated: Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed