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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorQueen's University, Belfast

About this trial

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. * 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

Qualifiers

Pregnant women with gestational diabetes mellitus

Aged 18-50 years old

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

35 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Queen's University, Belfast

Lead sponsor

Imperial College London

Collaborator