Pregnancy Outcomes: Effects of Metformin Study (POEM Study)
Status:
Not yet recruiting
Trial end date:
2040-12-01
Target enrollment:
Participant gender:
Summary
One approach to prevent the rising burden of diabetes is to address the issue of gestational
diabetes mellitus (GDM). GDM has a growing prevalence up to 5-10% (and even higher in
specific subgroups), with a pregnant population becoming older and more obese worldwide. GDM
increases the risks of complications during pregnancy, at delivery and on the longer term,
like type 2 diabetes (T2D) and persistent obesity, in mother and child. Moreover, insulin
added to diet as the standard care for GDM has disadvantages for mother (maintenance of
hyperinsulinaemia, increasing weight and blood pressure) and child (macrosomia,
hypoglycaemia) with related adverse pregnancy outcomes. Metformin, as an insulin sensitizer
targeting the cause of GDM, may have essential benefits, as suggested by observational
studies. However, RCTs with metformin (early positioned in the treatment of GDM) are still
lacking. The POEM study is the first Randomized controlled trial (RCT) in GDM to test the
hypothesis that metformin, early given from the start of the diagnosis GDM, on top of diet
and lifestyle improves clinically relevant pregnancy outcomes in mother and child during
pregnancy, at delivery and on the longer term - up to 20 years after birth.
Phase:
Phase 3
Details
Lead Sponsor:
Bethesda Diabetes Research Center
Collaborators:
Maastricht University Medical Center Martini Hospital Groningen Medical Centre Leeuwarden UMC Utrecht University Medical Center Groningen