Pregnancy Outcomes: Effects of Metformin Study (POEM Study)

• Status: Not yet recruiting
• Trial end date: 2040-12-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bethesda Diabetes Research Center
• Collaborators: Maastricht University Medical Center; Martini Hospital Groningen; Medical Centre Leeuwarden; UMC Utrecht; University Medical Center Groningen
• Treatments: Insulin; Metformin

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Diabetes mellitus before pregnancy, except previous GDM

• Proteïnuria: Urine Albumin-to-Creatinine Ratio (UACR) > 35 mg/mmol at screening

• Malignancy during the last 5 years before inclusion, except non-melanoma skin cancer

• Psychiatric and/or mood disorder potentially affecting compliance of treatment

• Chronic liver disease and/or Alanine aminotransferase aspartate transaminase (ASAT) and/or Alanine aminotransferase (ALAT) > 3x Upper Limit of Normal (ULN).

• Chronic renal failure with a Glomerular filtration rate (GFR) < 45 ml/min/1.73m2

• Chronic pulmonary failure with hypoxia

• Significantly uncontrolled hypertension - Systolic blood pressure (SBP) > 160 mm Hg despite medical treatment

• Chronic treatment with corticosteroids

• Intolerance for metformin and/or earlier use of metformin in this pregnancy

• Membership of the POEM study group

• Severe foetal anomaly at inclusion - like major neural tube and/or cardiac malformation

• Ruptured membranes

• Multiple pregnancy

• Inability to understand or read the Dutch language