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NCT Number: NCT02273297

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

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.

Recruiting

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Key information

Conditions

Pregnancy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Dana Dabelea, MD, PhD

CONTACT

[email protected]

303-724-4414

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Maternal factors

Other

Primary outcomes

  1. Fat mass

    Time frame: Birth

    Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.

  2. Fat mass

    Time frame: 5 years

    Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.

Secondary outcomes

  1. Fat mass

    Time frame: 5 months

    Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Dabelea, MD, PhD

CONTACT

[email protected]

303-724-4414

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Exploring the Fuel-mediated Programming of Neonatal Growth

Important dates

Study start
2009
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2014
Registry last updated
Mar 15, 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.

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