Actively Recruiting
Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM) - a Randomised Crossover Study
Led by Queen's University, Belfast · Updated on 2026-04-17
35
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
Q
Queen's University, Belfast
Lead Sponsor
I
Imperial College London
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how the order in which macronutrients are eaten affects blood sugar levels after meals in women with gestational diabetes mellitus (GDM). This study aims to understand differences in blood glucose spikes, gut hormone changes, feelings of fullness, and daily energy and nutrient intake based on whether protein and fat are consumed before or after carbohydrates. GDM is a type of glucose intolerance that starts during pregnancy and increases future risks for type 2 diabetes and cardiovascular disease. Participants will attend two study visits where they will eat a specially prepared breakfast meal consisting of scrambled eggs (protein and fat) and wholemeal toast (carbohydrate) in different orders. The order of eating these components will be randomly assigned, with one visit involving protein/fat before carbohydrates and the other visit reversing this order. Each participant serves as her own control. Meals will be consumed within 10 minutes, and visits will be spaced at least two days apart. During the visits, participants will undergo measurements including height, weight, blood glucose, and blood samples for hormone levels. They will also complete questionnaires on appetite and keep two food diaries. Researchers will monitor changes in post-meal glucose, insulin, gut hormones, satiety scores, and nutrient intake between the two meal sequences. The total study duration per participant includes two visits with a maximum of two weeks between them, allowing comparison of metabolic responses to different food orders.
CONDITIONS
Brief Title
Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with gestational diabetes mellitus
- Aged 18-50 years old
You will not qualify if you...
- History of type 1 or type 2 diabetes mellitus
- Dietary restrictions or clinically confirmed food allergies that may affect study requirements
- Pharmacologically managed gestational diabetes mellitus at the point of study entry
- Severe nausea and vomiting during pregnancy (hyperemesis gravidarum) at study entry
- Using anti-nausea medication such as dimenhydrinate, prochlorperazine, or promethazine
- Any other medical condition that limits ability to complete the study requirements
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks between visits
Participants attend two study visits where they consume a specially prepared breakfast meal with the order of macronutrients (protein/fat and carbohydrate) randomized and reversed between visits. This involves blood sample collection, glucose measurements, and completion of food diaries to assess the effect of food ordering on blood glucose and related outcomes.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Centre for Public Health, Institute of Clinical Sciences A
Belfast, United Kingdom, BT12 6BA
Actively Recruiting
Research Team
H
Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP
D
Danielle Logan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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