Actively Recruiting
Pregnancy Outcomes: Effects of Metformin Study (POEM Study)
Led by Bethesda Diabetes Research Center · Updated on 2022-02-10
500
Participants Needed
4
Research Sites
1253 weeks
Total Duration
On this page
Sponsors
B
Bethesda Diabetes Research Center
Lead Sponsor
M
Maastricht University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pregnancy Outcomes: Effects of Metformin Study (POEM Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women diagnosed with gestational diabetes defined by fasting plasma glucose > 5.3 mMol or 2-hour plasma glucose > 7.8 mMol after 75 gram oral glucose
- Provided written informed consent
- Aged 18 to 45 years
- Gestational age between 16 and 32 weeks at inclusion
- HbA1c at inclusion ≤ 48 mmol/mol (6.5%)
You will not qualify if you...
- Diabetes mellitus before pregnancy, except previous gestational diabetes
- Urine Albumin-to-Creatinine Ratio (UACR) > 35 mg/mmol at screening
- Cancer within the last 5 years, except non-melanoma skin cancer
- Psychiatric or mood disorders that may affect treatment compliance
- Chronic liver disease or liver enzymes (ASAT/ALAT) > 3 times upper normal limit
- Chronic kidney failure with GFR < 45 ml/min/1.73m2
- Chronic lung failure with hypoxia
- Uncontrolled hypertension with systolic blood pressure > 160 mm Hg despite treatment
- Ongoing corticosteroid treatment
- Intolerance to metformin or prior metformin use in this pregnancy
- Membership in the POEM study group
- Severe fetal anomalies like major neural tube or heart malformations
- Ruptured membranes
- Multiple pregnancy
- Inability to read or understand Dutch
- History of bariatric surgery
- Severe pregnancy-related vomiting (hyperemesis gravidarum)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Martini hospital Groningen
Groningen, Netherlands
Actively Recruiting
2
University Medical Center Groningen
Groningen, Netherlands
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3
Treant Zorggroep
Hoogenveen, Emmen, Stadskanaal, Netherlands
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4
Medical Center Leeuwarden
Leeuwarden, Netherlands
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Research Team
A
Adriaan Kooy, Dr
CONTACT
L
Louise Smit
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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