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NCT02244814 · ClinicalTrials.gov registry record · NA
Trial of Diet in Gestational Diabetes Mellitus: Metabolic Consequences to Mother and Offspring
A NA study of Gestational Diabetes Mellitus, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT02244814 is a NA study of Gestational Diabetes Mellitus that has completed, run by University of Colorado, Denver. The registered enrollment target is 105 participants, below the 412-participant average among 16 other Gestational Diabetes Mellitus trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02244814, a NA study of Gestational Diabetes Mellitus, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- BEHAVIORAL Low Carbohydrate/Conventional
- BEHAVIORAL Choosing Healthy Options in Carbohydrate Energy
Study Locations (1)
Colorado
- University of Colorado/Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2015-07 |
| Est. Completion | 2020-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02244814
The ClinicalTrials.gov registry entry for NCT02244814 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 16 other Gestational Diabetes Mellitus trials with a reported enrollment target (75% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gestational Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Low Carbohydrate/Conventional is the first listed.
NCT02244814 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT02244814 about?
NCT02244814 is a clinical study titled "Trial of Diet in Gestational Diabetes Mellitus: Metabolic Consequences to Mother and Offspring". 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 com...
What is the current status of trial NCT02244814?
This trial is currently completed. It is a NA study. The enrollment target is 105 participants. The study started on 2015-07. Estimated completion is 2020-11.
What conditions does trial NCT02244814 study?
This clinical trial studies the following conditions: Gestational Diabetes Mellitus.
What interventions are being tested in trial NCT02244814?
The interventions under investigation include: Low Carbohydrate/Conventional (BEHAVIORAL), Choosing Healthy Options in Carbohydrate Energy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02244814?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02244814 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.