Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Gestational Diabetes Mellitus
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

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 likel...

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.

Tracking Information

NCT #
NCT02394158
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