Preventing Recurrent Gestational Diabetes With Metformin (PRoDroME)

August 12, 2019 updated by: Imperial College London

Preventing Recurrent Gestational Diabetes Mellitus With Early Metformin Intervention

Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gestational diabetes mellitus (GDM) is a common medical complication of pregnancy and is associated with increased risks to mother and baby. The incidence is increasing reflecting changing pre-gravid female demographics. Once one pregnancy is complicated by GDM, subsequent pregnancies are more likely to be affected by the same condition. This reported risk of recurrence is estimated to range between 35 and 80%, with non-caucasian ethnicity being the strongest predictor of GDM recurrence. Evidence regarding further predictors of recurrent GDM is conflicting and measures that might prevent recurrence need exploring.

Metformin is commonly used in the treatment of established GDM and has been shown to reduce the incidence of GDM in the context of polycystic ovarian syndrome.

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • London North West Healthcare Trust
        • Contact:
        • Contact:
          • Mushtaqur Rahman, FRCP, PhD
      • London, United Kingdom, W2 1PG
        • Recruiting
        • Imperial College NHS Trust
        • Contact:
        • Contact:
          • Stephen Robinson, FRCP, MD
          • Phone Number: 0203 312 1253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancy;
  • 8-22 weeks gestation
  • Previous pregnancy complicated by gestational diabetes

Exclusion Criteria:

  • Established pre-existing diabetes (including unrecognised diabetes defined as a fasting plasma glucose ≥ 7.0mmol/L and/ or HbA1c ≥ 48mmol/mol); Contraindications to metformin therapy (creatinine ≥ 130μmol/L/ alanine transaminase ≥ 2.0 x upper limit normal/ previous intolerance to metformin)
  • Planned continued antenatal care/ delivery at centre not included in trial
  • Planned fast for cultural/ religious reasons e.g. Ramadan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention arm Metformin
Metformin (500mg tablets) to start at a dose of 500mg once daily with an increase of 500mg every five days until the maximum dose of 1000mg twice daily is reached.
Drug: Metformin
Placebo Comparator: Control arm placebo
Matched placebo tablets (500mg) to start at a dose of 500mg once daily with an increase of 500mg every five days until the maximum dose of 1000mg twice daily is reached.
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of Gestational Diabetes at any point during the course of pregnancy
Time Frame: From 12 weeks pregnancy until the onset of labour
From 12 weeks pregnancy until the onset of labour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal gestational weight gain
Time Frame: Difference between weight at 12 weeks gestation and 36 weeks gestation
Difference between weight at 12 weeks gestation and 36 weeks gestation
Requirement for insulin therapy
Time Frame: From 12 weeks gestation until 36 weeks gestation
From 12 weeks gestation until 36 weeks gestation
Postpartum glucose levels
Time Frame: 6 weeks postpartum
6 weeks postpartum
Levels of maternal physical and psychological health as assessed by questionnaires
Time Frame: From 12 weeks gestation until 6 weeks postpartum
From 12 weeks gestation until 6 weeks postpartum
Fetal birthweight and birthweight centile
Time Frame: At Birth
At Birth
Composite of neonatal outcomes (neonatal hypoglycaemia requiring treatment, respiratory distress syndrome requiring oxygen therapy/ continuous positive airway pressure, neonatal hyperbilirubinaemia requiring phototherapy).
Time Frame: At Birth
At Birth
Cost effectiveness of the intervention
Time Frame: From 12 weeks gestation until 6 weeks postpartum
Difference in requirement for medical services and unplanned hospital/ General Practitioner attendances between the two arms
From 12 weeks gestation until 6 weeks postpartum

Other Outcome Measures

Outcome Measure
Time Frame
Insulin resistance
Time Frame: From 12 weeks gestation until 6 weeks postpartum
From 12 weeks gestation until 6 weeks postpartum
Maternal triglyceride concentrations
Time Frame: From 12 weeks gestation until 6 weeks postpartum
From 12 weeks gestation until 6 weeks postpartum
Fetal hyperinsulinaemia
Time Frame: Delivery
Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Imperial College Healthcare NHS Trust
London North West Healthcare NHS Trust
The Novo Nordisk UK Research Foundation

Investigators

  • Principal Investigator: Stephen Robinson, FRCP, MD, Imperial College NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2015

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14SM1971
  • 2014-001244-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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