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NCT02273297 Clinical Trial

Healthy Start: Exploring the Fuel-mediated Programming of Neonatal Growth

Obesity Clinical Trial

Official title:
Exploring the Fuel-mediated Programming of Neonatal Growth

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02273297
Other study ID # 09-0563
Secondary ID R01DK076648UL1TR
Status Recruiting
Phase
First received
Last updated
Start date July 2009
Est. completion date July 2026

Study information
Verified date March 2024
Source University of Colorado, Denver
Contact Dana Dabelea, MD, PhD
Phone 303-724-4414
Email Dana.Dabelea@ucdenver.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2821
Est. completion date July 2026
Est. primary completion date July 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Maternal factors

Locations
Country Name City State
United States University of Colorado Denver Aurora Colorado

Sponsors (3)
Lead Sponsor Collaborator
University of Colorado, Denver National Center for Advancing Translational Sciences (NCATS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fat mass Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass. Birth
Primary Fat mass Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass. 5 years
Secondary Fat mass Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass. 5 months
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