Pregnancy Outcomes: Effects of Metformin Study (POEM Study)

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for pregnant women with diabetes that started in pregnancy (gestational diabetes). They will get metformin on top of usual care, or usual care alone.

Életkor

18 to 45 years

Nem

Women only

A betegség stádiuma

Gestational diabetes: fasting blood sugar above 5,3 mMol and/or blood sugar above 7,8 mMol two hours after drinking 75 gram glucose. Pregnancy must be 16 to 32 weeks along at the start.

Korábbi kezelés

No metformin earlier in this pregnancy. No long-term corticosteroid treatment. No past weight-loss (bariatric) surgery.

Biomarker vagy leletérték

HbA1c (long-term blood sugar test) at the start of 48 mmol/mol (6.5% Hb) or lower.

A részvétel fő kizáró okai

• Diabetes before this pregnancy, except earlier gestational diabetes
• Twins or more babies, broken waters, or a severe birth defect in the baby
• Kidney disease with GFR below 45 ml/min/1.73m2, or protein in the urine above 35 mg/mmol
• Cancer in the last 5 years (except non-melanoma skin cancer), or chronic liver disease
• Cannot read or understand Dutch, or severe pregnancy vomiting (hyperemesis gravidarum)

Ez a vizsgálat csak várandós résztvevőket keres. A regiszter mondata, amelyen ez alapul: * 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

A regiszter feltételei, szó szerint

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• 18 és 45 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• Metformin on top of usual careMár használt kezelés, összehasonlításként

  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.

  Kezelés: Metformin TEVA 850 mg

• Usual careNincs vizsgálati kezelés, összehasonlításként

  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.