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Clinical trialNCT04570111TerminatedInterventional

MOD Diet in Gestational Diabetes Mellitus

SponsorUniversity of Kansas Medical CenterEnrollment6Gestational Diabetes
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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 is more effective.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Kansas Medical Center

    Kansas City, Kansas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
22 Jan 2021
Primary completion
30 Jun 2022
Completion
30 Jun 2022
Last update posted
10 Sept 2022
Registered enrollment
6
Registry id
NCT04570111

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.