Effects of Metformin on Pregnancy Outcomes in Gestational Diabetes

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

This study tests if taking metformin along with diet and lifestyle changes can improve pregnancy outcomes for women with gestational diabetes and their babies.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Bethesda Diabetes Research Center (Academic / other)
• Locations: 4 sites (Groningen and 3 other locations)
• Trial ID: NCT02947503 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18-45 with a diagnosis of gestational diabetes between 16-32 weeks of gestation.

Not a fit: Patients with pre-existing diabetes, severe renal or liver disease, or significant psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce complications associated with gestational diabetes for both mothers and their children.

How similar studies have performed: Previous observational studies suggest potential benefits of metformin in managing gestational diabetes, but this is the first randomized controlled trial of its kind.

Eligibility 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
* 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 this trial is running

Groningen and 3 other locations

• 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

Conditions Gestational Diabetes; Insulin Resistance; Metformin; Hyperinsulinaemia; Prevention of Complications; Long Term Study; Mother and Child; Health Benefits