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NCT04570111 · ClinicalTrials.gov registry record · NA
MOD Diet in Gestational Diabetes Mellitus
A NA study, sponsored by University of Kansas Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT04570111 is a NA study that was terminated before completion, run by University of Kansas Medical Center. The registered enrollment target is 6 participants.
The verdict
NCT04570111, a NA study, was terminated before completion, sponsored by University of Kansas Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
Gestational diabetes (GDM) is a condition of high blood glucose (or "blood sugar") during pregnancy. GDM can cause harmful short-term and long-term health effects for mom and baby. Diet therapy is an effective way to achieve normal blood glucose for women with GDM, but the best diet is unknown. Diet strategies that improve blood glucose in GDM and that patients can follow are needed for better clinical care. In studies of non-pregnant individuals with diabetes, eating a high fat/protein breakfast as the only dietary change was enough to improve glucose control. Because highest blood glucose readings in GDM usually occur after breakfast, a high fat/protein breakfast could also improve glucose control in GDM. In this study, two dietary strategies for improving blood glucose will be compared. Ten women newly diagnosed with GDM (\<30 weeks in pregnancy) will be enrolled in a 12-day cross-over controlled feeding study with a high fat/protein breakfast, which is named a 'Macro-Optimized Diet' (MOD) or standard care diet (SC). In other words, subjects will have all food provided to them, and they will consume each diet for a few days while researchers monitor their blood glucose. Most nutrition aspects of the two diets will be similar, but the MOD diet will vary the timing of eating carbohydrate, protein, and fat to achieve fewer carbs at breakfast. After the 12-day controlled feeding period, participants will continue one of the study diets (as randomized) until delivery. During this time, research team dietitians will provide personalized nutrition education to support GDM self-management. The study will evaluate whether the diet is acceptable to women with GDM and their clinic providers. Data to be collected include blood glucose data, patient and provider feedback on diet acceptability, weight gain, the number of participants who are prescribed blood glucose control medications, and infant weight. These data will be used to evaluate trends pointing to whether one diet
Interventions
- OTHER MOD Diet
- OTHER Standard Care Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-01-22 |
| Est. Completion | 2022-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04570111
The ClinicalTrials.gov registry entry for NCT04570111 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MOD Diet is the first listed.
NCT04570111 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04570111 about?
NCT04570111 is a clinical study titled "MOD Diet in Gestational Diabetes Mellitus". Gestational diabetes (GDM) is a condition of high blood glucose (or "blood sugar") during pregnancy. GDM can cause harmful short-term and long-term health effects for mom and baby. Diet therapy is an effective way to achieve normal blood glucose for women with GDM, but the best diet is unknown. Diet...
What is the current status of trial NCT04570111?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2021-01-22. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT04570111?
The interventions under investigation include: MOD Diet (OTHER), Standard Care Diet (OTHER).
Who is sponsoring clinical trial NCT04570111?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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