Effects of Metformin on Pregnancy Outcomes in Gestational Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The POEM study investigates the impact of metformin on pregnant women diagnosed with gestational diabetes mellitus (GDM). This randomized controlled trial compares two groups: one receiving metformin alongside diet and lifestyle changes, and the other receiving diet and lifestyle changes alone. The study aims to assess various pregnancy outcomes at delivery and long-term health effects for both mother and child. It consists of three phases, including an observational extension to evaluate outcomes up to 20 years post-delivery.

Why it matters

Who can join: the full rules

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
* Proteinuria: 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
* Bariatric surgery in medical history
* Hyperemesis gravidarum

Where it's running

• Martini hospital Groningen
  Groningen, Netherlands Recruiting
• University Medical Center Groningen
  Groningen, Netherlands Recruiting
• Treant Zorggroep
  Hoogenveen, Emmen, Stadskanaal, Netherlands Recruiting
• Medical Center Leeuwarden
  Leeuwarden, Netherlands Recruiting

Study contacts

• Principal investigator: Adriaan Kooy, Dr. — Bdrc
• Study coordinator: Adriaan Kooy, Dr
• Email: a.kooy@treant.nl
• Phone: +31528286859

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.