Is metformin therapy in conjunction with lifestyle modifications more effective than lifestyle modifications alone in lowering the risk of gestational diabetes mellitus in pregnant women with metabolic dysfunction-associated steatotic liver disease (MASLD)? A protocol for parallel-arm superiority randomised controlled trial in tertiary care centres, Puducherry, South India.

ABSTRACT:

Background

Metabolic dysfunction-associated steatotic liver disease (MASLD) and gestational diabetes mellitus (GDM) are prevalent metabolic disorders in pregnancy, posing significant risks to maternal and fetal health. This study evaluates the effectiveness of metformin, in combination with lifestyle modifications, compared with lifestyle modifications alone, in reducing the incidence of diabetes, pro-inflammatory liver markers, adverse maternal and neonatal outcomes and total gestational weight gain in pregnant women diagnosed with MASLD in the first trimester.

Methods

This parallel-arm, randomised controlled trial will recruit pregnant women (≤14 weeks of gestation) with confirmed MASLD from antenatal clinics of tertiary care public hospitals in Puducherry, India. Particip

SUBMITTER: Jayaseelan V 

PROVIDER: S-EPMC12766765 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature