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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. * 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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Pregnant women with gestational diabetes mellitus

• Aged 18-50 years old

Locations
Other Locations
United Kingdom
Centre for Public Health, Institute of Clinical Sciences A
RECRUITING
Belfast
Contact Information
Primary
Jayne Woodside, PhD
j.woodside@qub.ac.uk
02890 978942
Backup
Danielle Logan, PhD
d.logan@qub.ac.uk
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 35
Treatments
Experimental: Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat.
Participants 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 and on their second study 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.
Experimental: Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate.
Participants 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 and on their second study 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.
Related Therapeutic Areas
Sponsors
Leads: Queen's University, Belfast
Collaborators: Imperial College London

This content was sourced from clinicaltrials.gov