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Trial record 10 of 115 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetes, Gestational"

Preventing Recurrent Gestational Diabetes With Metformin (PRoDroME)

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ClinicalTrials.gov Identifier: NCT02394158
Recruitment Status : Recruiting
First Posted : March 20, 2015
Last Update Posted : November 10, 2016
Sponsor:
Collaborators:
Imperial College Healthcare NHS Trust
London North West Healthcare NHS Trust
The Novo Nordisk UK Research Foundation
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Drug: Metformin Drug: placebo Phase 4

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  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Preventing Recurrent Gestational Diabetes Mellitus With Early Metformin Intervention
Study Start Date : December 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Development of Gestational Diabetes at any point during the course of pregnancy [ Time Frame: From 12 weeks pregnancy until the onset of labour ]

Secondary Outcome Measures :
  1. Maternal gestational weight gain [ Time Frame: Difference between weight at 12 weeks gestation and 36 weeks gestation ]
  2. Requirement for insulin therapy [ Time Frame: From 12 weeks gestation until 36 weeks gestation ]
  3. Postpartum glucose levels [ Time Frame: 6 weeks postpartum ]
  4. Levels of maternal physical and psychological health as assessed by questionnaires [ Time Frame: From 12 weeks gestation until 6 weeks postpartum ]
  5. Fetal birthweight and birthweight centile [ Time Frame: At Birth ]
  6. 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 ]
  7. 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


Other Outcome Measures:
  1. Insulin resistance [ Time Frame: From 12 weeks gestation until 6 weeks postpartum ]
  2. Maternal triglyceride concentrations [ Time Frame: From 12 weeks gestation until 6 weeks postpartum ]
  3. Fetal hyperinsulinaemia [ Time Frame: Delivery ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394158


Contacts
Contact: Stephen Robinson, FRCP, MD 0203 312 1253 stephen.robinson@imperial.nhs.uk
Contact: Rochan Agha-Jaffar, BMBS, MRCP 0207 594 6140 r.agha-jaffar@imperial.ac.uk

Locations
United Kingdom
Imperial College NHS Trust Recruiting
London, United Kingdom, W2 1PG
Contact: Stephen Robinson, FRCP, MD    0203 312 1253      
Contact: Rochan Agha-Jaffar, BMBS, MRCP    0207 594 6140    r.agha-jaffar@imperial.ac.uk   
London North West Healthcare Trust Recruiting
London, United Kingdom
Contact: Mushtaqur Rahman, FRCP, PhD         
Contact: Rochan Agha-Jaffar, BMBS, MRCP    0207 594 6140    r.agha-jaffar@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
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:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02394158     History of Changes
Other Study ID Numbers: 14SM1971
2014-001244-38 ( EudraCT Number )
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Imperial College London:
Recurrent Gestational Diabetes Mellitus
Prevention
Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs