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

NCT06896799 | Recruiting

• 1 other identifier: 25/NI/0004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational Diabetes Mellitus; Post-prandial glycaemia; Food Ordering

Outcome Measures

Primary Outcomes (1)

• Postprandial Glucose

  The difference in the magnitude of postprandial rise in blood glucose between the two test meals.

  Difference between Visit 1 [time 0 and 125 minutes] and Visit 2 [time 0 and 125 minutes]

Secondary Outcomes (8)

• Insulin

  Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]

• C-Peptide

  Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]

• Total Ghrelin

  Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]

• Glucagon (GCG)

  Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]

• Glucagon-like peptide-1 (GLP-1)

  Difference between Visit 1 [time 0 and 30 minutes] and Visit 2 [time 0 and 30 minutes]

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

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

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, 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: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat.

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

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, 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."

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Participants must be pregnant with GDM to take part in the study, and therefore must be female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women with gestational diabetes mellitus
• Aged 18-50 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Imperial College London: collaborator

Study Sites (1)

Centre for Public Health, Institute of Clinical Sciences A

Belfast, BT12 6BA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP

CONTACT

+44 (0) 28 9097 6350; h.ohara@qub.ac.uk

Danielle Logan, PhD

CONTACT

+44 (0) 28 9097 6350; d.logan@qub.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to blind participants or researchers in this study due to the nature of the nutritional intervention. However, the allocation to each group will be blinded using envelopes.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This will be a randomised crossover study. 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.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 26, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data should be available from December 2025 and will be available for 2 years.
• Access Criteria: Use of results in a meta-analysis will be available by contacting the research team.

Locations

GB (1)