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Trial of Diet in Gestational Diabetes Mellitus: Metabolic Consequences to Mother and Offspring

NCT02244814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-12-19

No results posted yet for this study

Summary

The rapidly rising risk of gestational diabetes pregnant women demands that an effective diet strategy be developed due to the high risk of fetal overgrowth, which places the newborn at increased risk for childhood obesity and metabolic syndrome. The aims of this randomized clinical trial are to compare the effects of an 8-wk isocaloric higher complex carbohydrate/lower fat diet vs. a conventional lower carbohydrate (higher fat) diet on glycemic and lipid profiles, maternal insulin resistance, placenta nutrient transporters, the maternal microbiome, neonatal intrahepatic fat, and neonatal total adiposity (primary outcome). The investigators will then follow the infants for 1-yr and measure maternal breast milk and infant microbiome composition to observe if they impact net fat mass gain differently in infants exposed to one diet vs. the other. Identifying a diet for gestational diabetes mellitus women that can effectively alter maternal/fetal metabolism is critical to reducing short- and long-term metabolic risk in this growing cohort of mothers and infants and has the potential to be applicable to overweight/obese pregnant women.

Conditions

  • Gestational Diabetes Mellitus

Interventions

BEHAVIORAL

Low Carbohydrate/Conventional

Lower-carbohydrate/conventional diet (usual care)

BEHAVIORAL

Choosing Healthy Options in Carbohydrate Energy

Choosing Healthy Options in Carbohydrate Energy

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Teri L Hernandez, PhD, RN · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
36 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-11-30
Completion
2020-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02244814 on ClinicalTrials.gov