NCT06896799 Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM)

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This trial targets 35 participants in total. It began in 2025-12-11 with a primary completion date of 2026-12-31.

Brief Summary

The goal of this clinical trial is to determine whether the sequence of macronutrient consumption affects post-prandial glycaemia in women with gestational diabetes mellitus. The main questions it aims to answer are: * The difference in the magnitude of postprandial rise in blood glucose between the two test meals as measured by Flash Glucose Monitoring (FGM) sensor, alongside blood/serum glucose from collected intravenous blood samples and finger prick results. * The difference in the magnitude of postprandial change in serum levels of gut hormones between the two test meals. * The difference in mean change in pre-post ingestion satiety scores between the two test meals. * The difference in 24 hour energy and macronutrient intake following the two test meals. Participants will attend two study visits at the Centre for Public Health, with an interval of at least two days between the visits and complete the following, anthropometric measurements, demographic and appetite questionnaires, glucose measurements, two food diaries and fasting blood samples and the consumption of the study breakfast. Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. Researchers will compare the results from participants between the two test meals to see if the order of macronutrient consumption has any effect on post-prandial glycaemia, gut hormones, satiety scores and energy and macronutrient intake.

Eligibility Criteria

Inclusion Criteria: * Pregnant women with gestational diabetes mellitus * Aged 18-50 years old * Between 24-37 weeks pregnant Exclusion Criteria: * History of type 1 or type 2 diabetes mellitus * Dietary restrictions or clinically confirmed food allergies that may affect study requirements * Pharmacologically managed GDM at the point of study entry * Hyperemesis gravidarum at the point of study entry (i.e. prolonged/severe nausea and vomiting) * Using antiemetic medication (e.g. dimenhydrinate, prochlorperazine, promethazine) * Any other problems or medical conditions that would substantially limit their ability to complete the study requirements Participants can be recruited onto the study if they have previously had GDM in another pregnancy. Participants can also be recruited if they are involved in other research studies, but this will depend on the study type and the decision will be made by the Chief/Principal Investigator.

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