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

RecruitingNAAges 18 Years - 50 YearsFemaleQueen's University, Belfast
NCT06896799 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 v

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📋 Eligibility rules (as published)
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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What it tests

  • Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat.
  • Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate.
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Where

1 site
Centre for Public Health, Institute of Clinical Sciences A
Belfast, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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