Food order and after-meal blood sugar in gestational diabetes
Official title: Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM) - a Randomised Crossover Study
Run by Queen's University, Belfast · NCT06896799 · Data updated 2026-11-12
This tests whether eating protein and fat before carbohydrates lowers after-meal blood sugar in pregnant women with gestational diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 35 (estimated) |
| Sponsor | Queen's University, Belfast Academic / other |
| Locations | 1 site (Belfast) |
| Status | Recruiting |
| Started | December 11, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT06896799 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18–50 years with a current diagnosis of gestational diabetes who are not being treated pharmacologically and who have no clinically significant food allergies or severe nausea are ideal candidates.
✕Probably not a fit
Women with pre-existing type 1 or type 2 diabetes, those already on medication for GDM, with hyperemesis gravidarum, or with food allergies that prevent the test meals are unlikely to benefit from this approach in the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pregnant women with gestational diabetes attend two visits at the Centre for Public Health and consume the same breakfast in two different orders: protein/fat before carbohydrate, and carbohydrate before protein/fat. The trial uses a randomized crossover approach with at least a two-day gap between visits, collecting serial blood glucose measurements, fasting blood for gut hormones, appetite/satiety questionnaires, anthropometry, and 24-hour food diaries. Primary comparisons include peak and magnitude of postprandial glucose rise, hormone responses, satiety changes, and subsequent energy and macronutrient intake between the two meal orders. The protocol is designed to test short-term physiological and behavioral effects of macronutrient sequencing in women with GDM.
Why it matters
Potential benefit: If successful, changing the order you eat foods could lower after-meal blood sugar and might reduce the need for medication in some women with GDM.
How similar studies have gone: Prior studies in non-pregnant adults and early reports indicate eating protein/fat before carbohydrates can reduce postprandial glucose peaks by about 40%, but evidence in pregnant women with GDM is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women with gestational diabetes mellitus * Aged 18-50 years old * Between 24-37 weeks pregnant Exclusion Criteria: * 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.
Where it's running
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Centre for Public Health, Institute of Clinical Sciences A
Belfast, United Kingdom Recruiting
Study contacts
- Principal investigator: Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP — Queen's University, Belfast
- Study coordinator: Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP
- Email: h.ohara@qub.ac.uk
- Phone: +44 (0) 28 9097 6350
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.