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.
Pregnant women with gestational diabetes mellitus
Aged 18-50 years old
Between 24-37 weeks pregnant
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)
Crossover
Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat.
Other interventionParticipants who are randomised to eat the protein/fat-based component (scrambled egg) of the meal before the carbohydrate-based component (wholemeal toast) on their first study visit, will be asked to eat the meal in the reverse order at their second study visit. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival at their second study visit.
Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate.
Other interventionParticipants who are randomised to eat the carbohydrate-based component (wholemeal toast) of the meal before the protein/fat-based component (scrambled egg) on their first study visit, will be asked to eat the meal in the reverse order at their second study visit. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival at their second study visit.
Postprandial Glucose
The difference in the magnitude of postprandial rise in blood glucose between the two test meals. We will look at interstitial glucose from the FGM sensor alongside blood/serum glucose from collected intravenous blood samples and finger prick results.
Insulin
The difference in the magnitude of postprandial change in serum levels of insulin between the two test meals.
C-Peptide
The difference in the magnitude of postprandial change in serum levels of c-peptide between the two test meals.
Total Ghrelin
The difference in the magnitude of postprandial change in serum levels of total ghrelin between the two test meals.
Glucagon (GCG)
The difference in the magnitude of postprandial change in serum levels of GCG between the two test meals.
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Queen's University, Belfast
Lead sponsor
Imperial College London
Collaborator
