Preventing Recurrent Gestational Diabetes With Metformin

• Status: Unknown status
• Trial end date: 2019-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Imperial College London
• Collaborators: Imperial College Healthcare NHS Trust; London North West Healthcare NHS Trust; The Novo Nordisk UK Research Foundation
• Treatments: Metformin

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