Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT05344066
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant women ≥18 years
2. BMI of ≥27.5kg/m2 or a BMI ≥25 kg/m2 in high risk minority ethnic group (i.e. South Asian, Black African, African Caribbean) and \<50 kg/m2 at booking appointment (8-12 weeks' gestation)
3. Newly diagnosed GDM according to local diagnostic criteria (fasting glucose ≥5.3mmol/l and/or 2-hour postprandial glucose ≥8.5mmol/l in a 75g OGTT) scheduled to receive first line diet and physical activity (best NHS care)
4. 24-30 weeks pregnant at screening appointment
Exclusion Criteria:
1. Pregestational type 1 or type 2 diabetes.
2. Fasting glucose of ≥7 or 2-hour postprandial of ≥11 on OGTT (immediate intervention with medication would be required in this group of women)
3. Current multiple pregnancy
4. Maturity Onset Diabetes of the Young (MODY)
5. Significant comorbid disease that in PI's opinion would preclude participation in the study e.g. chronic kidney disease, significant cardiac disease, history of disordered eating or severe psychological problems.
6. Current participation in a GDM medication treatment trial
7. People who are not capable of providing informed consent or adhering to the monitoring and safety protocols
8. People who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy, and/or those prescribed weight loss medications (e.g. orlistat).
9. Medications at the time of the OGTT that may interfere with results (e.g. high dose oral steroids, immunosuppressants)
10. Previous history of intrauterine growth restriction
11. Women who have lost more than 5% of their weight from booking appointment to screening appointment.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05344066
Study Brief:
Protocol Section:
NCT05344066