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Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus

Study acronym: GUARD
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date changed from estimate of Jan 31, 2023 to Dec 31, 2024v3 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 158 to confirmed 64
    • Study completion date: Jun 30, 2023 to May 31, 2025
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Jan 31, 2022 to Jan 31, 2023
    • Start date changed from estimate of Jul 1, 2020 to Jul 1, 2021
    • Study sites: 0 to 1
    • Study completion date: Jun 30, 2022 to Jun 30, 2023
    • Secondary endpoints: details revised at 1 of 25 entries
    • Study description revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
King's College London
136 trials monitored
See 3 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
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 diagnosed with GDM, and require pharmacological treatment. Glucose control is our primary measure. Each year in the UK approximately 35,000 women develop diabetes during pregnancy, a condition called gestational diabetes mellitus (GDM), which increases the risk of adverse outcomes for both mother and child. Metformin, although unlicensed for used in pregnancy, is the most commonly used first line pharmacological treatment. However, there is increasing concern about its widespread use during pregnancy, because of its limited efficacy and because of potential safety concerns. Other common treatments have not been shown to be superior. Therefore, there is an unmet need for additional therapies. Ursodeoxycholic acid (UDCA) is commonly used in pregnancy for the treatment of intrahepatic cholestasis of pregnancy. It is currently not an established/licensed treatment for GDM. However data from observational studies of women with cholestasis in pregnancy has flagged this to be a potential effective treatment to control blood glucose levels in GDM. The investigators will ask women to attend three study visits, which will coincide with the time of their antenatal appointments. The trial aims to collect a range of clinical and research blood samples, to measure quality of life and treatment satisfaction through two questionnaires, and will will ask women to wear a continuous glucose monitor for three 10 day periods. There will be a number of optional assessments that participants will be offered. The primary outcome will be the fasting blood glucose concentration at 36 weeks of gestation. The investigators intend to carry out this study at 3 sites in the United Kingdom (Guy's and St Thomas, Imperial College and Nottingham), and it has been funded by a J.P Moulton Foundation grant.
Trial Details
NCT Number NCT04407650
Lead Sponsor King's College London
Collaborators: Guy's and St Thomas' NHS Foundation Trust
Conditions
(from sponsor)		 Gestational Diabetes
Related terms Diabetes, Gestational
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov