Pregnancy Outcomes: Effects of Metformin Study (POEM Study), a Long Term Randomized Controlled Study in Gestational Diabetes

Who is this study for? Patients with gestational diabetes
What treatments are being studied? Metformin
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Pregnant women with GDM defined as a Fasting Plasma Glucose (FPG) \> 5,3 mMol and/or an Oral Glucose Tolerance test (OGTT) with a Plasma glucose (PG) \> 7,8 mMol, two hours after the oral intake of 75 gram glucose

• Written informed consent

• Age 18-45 years

• Gestational age at inclusion 16-32 weeks

• Glycohemoglobin test (HbA1c) at inclusion ≤ 48 mmol/mol (6.5% Hb)

Locations
Other Locations
Netherlands
Martini hospital Groningen
RECRUITING
Groningen
University Medical Center Groningen
RECRUITING
Groningen
Treant Zorggroep
RECRUITING
Hoogenveen, Emmen, Stadskanaal
Medical Center Leeuwarden
RECRUITING
Leeuwarden
Contact Information
Primary
Adriaan Kooy, Dr
a.kooy@treant.nl
+31528286859
Backup
Louise Smit
l.ismit@treant.nl
Time Frame
Start Date: 2019-11-26
Estimated Completion Date: 2043-12
Participants
Target number of participants: 500
Treatments
Active_comparator: Metformin on top of usual care
Metformin TEVA 850 mg (1-3 times daily) added to usual care from start of the diagnosis GDM.~Usual care has been defined as intensive counselling for diet and lifestyle plus insulin therapy if needed.~Intervention: metformin TEVA 850 mg (1-3 times daily) on top of usual care.
No_intervention: Usual care
Usual care from start of the diagnosis GDM. Control group without metformin. Usual care has been defined as intensive counselling for diet and lifestyle plus insulin therapy if needed.~Intervention: usual care.
Sponsors
Leads: Bethesda Diabetes Research Center
Collaborators: University Medical Center Groningen, Nij Smellinghe Hosptial, Martini Hospital Groningen, Treant Zorggroep, Maastricht University Medical Center, Frisius Medisch Centrum

This content was sourced from clinicaltrials.gov