Status:
UNKNOWN
Manchester Intermittent Diet in Gestational Diabetes Acceptability Study
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
University of Manchester
Conditions:
Gestational Diabetes
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
A two-arm non-blinded randomised feasibility protocol trial designed to assess the feasibility, safety, and acceptability of an intermittent low energy diet (ILED) vs best National Health Service (NHS...
Detailed Description
Overall aim: The aim of this trial is to test the safety, feasibility, and acceptability of an ILED in GDM to inform a future large-scale RCT. Background: Up to 16% of pregnant women in the United ...
Eligibility Criteria
Inclusion
- Pregnant women ≥18 years
- 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)
- 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)
- 24-30 weeks pregnant at screening appointment
Exclusion
- Pregestational type 1 or type 2 diabetes.
- Fasting glucose of ≥7 or 2-hour postprandial of ≥11 on OGTT (immediate intervention with medication would be required in this group of women)
- Current multiple pregnancy
- Maturity Onset Diabetes of the Young (MODY)
- 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.
- Current participation in a GDM medication treatment trial
- People who are not capable of providing informed consent or adhering to the monitoring and safety protocols
- 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).
- Medications at the time of the OGTT that may interfere with results (e.g. high dose oral steroids, immunosuppressants)
- Previous history of intrauterine growth restriction
- Women who have lost more than 5% of their weight from booking appointment to screening appointment.
Key Trial Info
Start Date :
November 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05344066
Start Date
November 24 2022
End Date
July 31 2024
Last Update
May 3 2024
Active Locations (1)
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1
Manchester University NHS Foundation trust
Manchester, United Kingdom, M13 9WU