Overview

This trial is active, not recruiting.

Conditions pregnancy, obesity
Treatment maternal factors
Sponsor University of Colorado, Denver
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date July 2009
End date December 2019
Trial size 2821 participants
Trial identifier NCT02273297, 09-0563, R01DK076648, UL1TR001082

Summary

The purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Fat mass
time frame: Birth
Fat mass
time frame: 5 years

Eligibility Criteria

Male or female participants at least 16 years old.

Inclusion Criteria: - Pregnant women and infants - Prior to 23 completed weeks of gestation - Live in Colorado Exclusion Criteria: - Multiple gestation - Preexisting - cancer - psychiatric disease - steroid-dependent asthma, or - diabetes - Previous premature delivery prior to 25 weeks gestation or fetal demise

Additional Information

Official title Exploring the Fuel-mediated Programming of Neonatal Growth
Principal investigator Dana Dabelea, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.