Status:
ACTIVE_NOT_RECRUITING
Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus
Lead Sponsor:
King's College London
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
16-45 years
Phase:
PHASE4
Brief Summary
GUARD is a Clinical Trial that wants to explore the impact of UDCA compared to metformin in the treatment of GDM. The trial wants to recruit 158 women who are overweight or obese who have been diagnos...
Detailed Description
GUARD is a two-armed, randomised, controlled, open label multicentre clinical trial with optional observational mechanistic study in a subgroup from each arm, comparing Ursodeoxycholic Acid to Metform...
Eligibility Criteria
Inclusion
- Women between 16 and 45 years of age with GDM diagnosed at 26+0 to 30+6 weeks' gestation in accordance with the NICE guidelines (one or more glucose concentrations of ≥5.6 mmol/l fasting or ≥7.8 mmol/l 2 hours after a standard 75g OGTT, and requiring pharmacological treatment).
- Overweight or obese (Booking BMI ≥25 kg/m2)
- Planned antenatal, intrapartum and postpartum care at the participating centre (i.e. not planning to move before delivery).
Exclusion
- Unwilling/unable to give written informed consent and comply with the requirements of the study protocol
- Multiple pregnancies (twins, triplets etc) in current pregnancy
- Congenital anomaly on ultrasound requiring fetal medicine input
- Previous diagnosis of diabetes outside pregnancy
- HbA1c at booking \>48 mmol/mol or ≥6.5% during current pregnancy (if available)
- Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (within previous year) in the opinion of the responsible clinician or the CI.
- Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR \<60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results in the opinion of the responsible clinician or the CI.
- Not fluent in English and absence of interpreter or translation services (ie telephone translation services)
- Participating in another intervention study where the results could influence GDM-related endpoints, in the opinion of the responsible clinician or the CI, or participation in a CTIMP during current pregnancy.
- Known allergy/hypersensitivity/intolerance to the active substance or excipients, or patients taking any medications which are contraindicated as per IMP SmPC
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04407650
Start Date
July 1 2021
End Date
May 31 2025
Last Update
April 25 2025
Active Locations (1)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH