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Study identifier: NCT02947503 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Pregnancy Outcomes: Effects of Metformin Study (POEM Study)

Condition: Gestational Diabetes · Insulin Resistance  ·  Sponsor: Bethesda Diabetes Research Center

PhasePhase 3
Planned participants500
Who can joinFemale, 18 Years to 45 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Adriaan Kooy, Dr  ·  +31528286859  ·  a.kooy@treant.nl

Louise Smit  ·  l.ismit@treant.nl

Always discuss trial participation with your own doctor first.

Locations (4)

Martini hospital GroningenGroningen, NetherlandsRecruiting
University Medical Center GroningenGroningen, NetherlandsRecruiting
Treant ZorggroepHoogenveen, Emmen, Stadskanaal, NetherlandsRecruiting
Medical Center LeeuwardenLeeuwarden, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT02947503