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Background <p>Early gestational glucose intolerance (EGGI), defined as a 2-hour postprandial blood glucose level &gt; 110&#xa0;mg/dL (6.1 mmol/L) before 11 weeks of gestation, may identify women at increased risk of developing gestational diabetes mellitus (GDM). This study evaluated whether the addition of metformin to medical nutrition therapy (MNT) could reduce progression to GDM and improve pregnancy outcomes.</p> Methods <p>In this RCT, 220 pregnant women with EGGI identified before 9 weeks of gestation were randomized to receive either MNT plus metformin 250&#xa0;mg twice daily or MNT alone. Participants underwent serial glucose assessment during pregnancy according to the Diabetes in Pregnancy Study Group India (DIPSI) screening framework. Maternal and neonatal outcomes were compared. Adjusted risk ratios (aRRs) were estimated using multivariable Poisson regression with robust error variance.</p> Results <p>Progression to GDM was significantly lower in the metformin group than in the MNT-only group (2.73% vs. 84.55%; aRR 0.036, 95% CI 0.012–0.106; <i>p</i> &lt; 0.0001). Metformin was also associated with lower risks of hypertension, polyhydramnios, large-for-gestational-age infants, cesarean delivery, and neonatal intensive care unit admission. These associations remained significant after adjustment for potential confounders.</p> Conclusion <p>Early initiation of metformin in addition to MNT among women with EGGI was associated with a substantial reduction in progression to GDM and improved fetomaternal outcomes. Larger multicentre studies are needed to confirm these findings and determine their applicability to broader populations.</p> Trial Registration <p>The study was registered with the Clinical Trials Registry of India (CTRI/2024/07/071360) on 25.07.2024.</p>

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Prevention of GDM by treating early gestational glucose intolerance with and without metformin: a randomized controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月1日

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  • Pikee Saxena,
  • Srilekha Thupili,
  • V Seshiah,
  • Vidhi Chaudhary,
  • Anjalakshi Chandrasekar,
  • Parijat Gogoi,
  • Rajesh Jain

摘要

Background

Early gestational glucose intolerance (EGGI), defined as a 2-hour postprandial blood glucose level > 110 mg/dL (6.1 mmol/L) before 11 weeks of gestation, may identify women at increased risk of developing gestational diabetes mellitus (GDM). This study evaluated whether the addition of metformin to medical nutrition therapy (MNT) could reduce progression to GDM and improve pregnancy outcomes.

Methods

In this RCT, 220 pregnant women with EGGI identified before 9 weeks of gestation were randomized to receive either MNT plus metformin 250 mg twice daily or MNT alone. Participants underwent serial glucose assessment during pregnancy according to the Diabetes in Pregnancy Study Group India (DIPSI) screening framework. Maternal and neonatal outcomes were compared. Adjusted risk ratios (aRRs) were estimated using multivariable Poisson regression with robust error variance.

Results

Progression to GDM was significantly lower in the metformin group than in the MNT-only group (2.73% vs. 84.55%; aRR 0.036, 95% CI 0.012–0.106; p < 0.0001). Metformin was also associated with lower risks of hypertension, polyhydramnios, large-for-gestational-age infants, cesarean delivery, and neonatal intensive care unit admission. These associations remained significant after adjustment for potential confounders.

Conclusion

Early initiation of metformin in addition to MNT among women with EGGI was associated with a substantial reduction in progression to GDM and improved fetomaternal outcomes. Larger multicentre studies are needed to confirm these findings and determine their applicability to broader populations.

Trial Registration

The study was registered with the Clinical Trials Registry of India (CTRI/2024/07/071360) on 25.07.2024.