Metformin treatment among pregnant women with fatty liver condition to prevent diabetes during pregnancy

Effectiveness of Metformin prophylaxis with lifestyle modification in reducing the risk of Gestational Diabetes Mellitus, compared to only Lifestyle Modifications Among Pregnant mothers with Non-Alcoholic Fatty Liver Disease in a Tertiary care hospital, Puducherry – A parallel arm superiority randomized trial - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060930

Enrollment

296

Registered

2023-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified Health Condition 2: O266- Liver and biliary tract disordersin pregnancy, childbirth and the puerperium

Interventions

Intervention1: Metformin Prophylaxis with lifestyle modification: Metformin tablet will be prescribed in the intervention group with a dosage of 500mg BD starting from the diagnosis of NAFLD (first tr

Eligibility

Inclusion criteria

Inclusion criteria: -Gestational age lessthan or equal to 14 weeks -Not on any hypoglycaemic drugs -Competent mental health status -Without pre-existing diabetes .

Exclusion criteria

Exclusion criteria: -History of advanced medical conditions such as chronic liver disease, hypertensive disorders (physical activity may be contraindicated and potentially confound adverse pregnancy outcome), advanced stage of renal disease (Stage >3b; GFR -Known allergy to the drug Metformin

Design outcomes

Primary

Measure	Time frame
a.Incidence of GDM b. Level of pro-inflammatory markers & grading of MASLD c. 1. Maternal adverse outcome: Hypertensive disorders in pregnancy, Polyhydramnios, Genito-urinary infections, Caesarean delivery and Postpartum haemorrhage. 2. Neonatal adverse outcome: Macrosomia, still birth, Intra-uterine death, Birth injury, Shoulder dystocia, Respiratory distress and Neonatal hypoglycemia. Timepoint: a. 24-28 weeks and 32-36 weeks of gestation to evaluate the incidence of GDM b & c. After delivery, up to 6 weeks of postpartum to evaluate the progression of MASLD and adverse pregnancy outcomes	—

Measure

Time frame

a.Incidence of GDM b. Level of pro-inflammatory markers & grading of MASLD c. 1. Maternal adverse outcome: Hypertensive disorders in pregnancy, Polyhydramnios, Genito-urinary infections, Caesarean delivery and Postpartum haemorrhage. 2. Neonatal adverse outcome: Macrosomia, still birth, Intra-uterine death, Birth injury, Shoulder dystocia, Respiratory distress and Neonatal hypoglycemia. Timepoint: a. 24-28 weeks and 32-36 weeks of gestation to evaluate the incidence of GDM b & c. After delivery, up to 6 weeks of postpartum to evaluate the progression of MASLD and adverse pregnancy outcomes

—

Secondary

Measure	Time frame
Total weight gain during pregnancyTimepoint: after delivery up to 1 month postpartum	—

Countries

India

Contacts

Public ContactDr VENKATACHALAM JAYASEELAN

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)

drvenkatpgi@gmail.com9244489850

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026