Manchester Intermittent Diet in Gestational Diabetes Acceptability Study

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Apr 22, 2022

Keywords

ClinConnect Summary

The Manchester Intermittent Diet in Gestational Diabetes Acceptability Study is a clinical trial that is looking at two different ways to help women manage gestational diabetes, a type of diabetes that can develop during pregnancy. This study is comparing an intermittent low energy diet (ILED) with the best care currently offered by the National Health Service (NHS). The goal is to see if the new diet is safe, acceptable, and feasible for women who are pregnant and have obesity along with gestational diabetes.

To be eligible for this study, participants need to be women who are at least 18 years old, are between 24 to 30 weeks pregnant, and have a body mass index (BMI) of 27.5 or higher (or 25 or higher if they belong to certain minority groups). They must also be newly diagnosed with gestational diabetes based on specific blood sugar levels. Women with certain health conditions, a history of type 1 or type 2 diabetes, or other serious health issues are not eligible to participate. Women who join the trial will receive either the intermittent diet or the usual NHS care, and they will be monitored to ensure their safety throughout the study.

Gender

FEMALE

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.