Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02273297
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease Intervention/treatment
Pregnancy Obesity Other: Maternal factors

Layout table for study information
Study Type : Observational
Actual Enrollment : 2821 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring the Fuel-mediated Programming of Neonatal Growth
Study Start Date : July 2009
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Group/Cohort Intervention/treatment
Pregnant women and their offspring
Ethnically diverse pregnant women and their offspring
Other: Maternal factors



Primary Outcome Measures :
  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 Outcome Measures :
  1. Fat mass [ Time Frame: 5 months ]
    Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants were recruited from prenatal obstetrics clinics at the University of Colorado Hospital outpatient pavilion.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273297


Locations
Layout table for location information
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Dana Dabelea, MD, PhD University of Colorado, Denver

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02273297     History of Changes
Other Study ID Numbers: 09-0563
R01DK076648 ( U.S. NIH Grant/Contract )
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Body composition
Body size