Food order and after-meal blood sugar in gestational diabetes
Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM) - a Randomised Crossover Study
This tests whether eating protein and fat before carbohydrates lowers after-meal blood sugar in pregnant women with gestational diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Queen's University, Belfast Academic / other |
| Locations | 1 site (Belfast) |
| Trial ID | NCT06896799 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women with gestational diabetes mellitus * Aged 18-50 years old 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 this trial is running
Belfast
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.