Clinical Research Directory

Effect of Dapagliflozin on Metabolic Parameters in Patients With Non-Alcoholic Fatty Liver Disease

Sponsor: Shalamar Hospital

Summary

This study was designed to assess the effect of dapagliflozin on body weight, blood sugar, liver enzymes, and blood fats in adults with non-alcoholic fatty liver disease (NAFLD), a condition involving excess fat accumulation in the liver. The study hypothesis was that changes in these measurements after 12 weeks would differ significantly between participants receiving dapagliflozin and those receiving placebo. The study was designed as a randomized, single-blind trial at the Department of Medicine, Shalamar Hospital, Lahore. Planned enrolment was 146 adults aged 20-70 years with NAFLD confirmed by ultrasound and a body mass index of at least 29 kg/m². Participants were to be randomly assigned to two equal groups of 73. One group was to receive dapagliflozin 10 mg by mouth once daily for 12 weeks, while the other was to receive an identical-looking placebo tablet containing no active medicine. Participants were to remain unaware of their assigned treatment. Both groups were to receive the same advice regarding diet, weight reduction, physical activity, and management of metabolic risk factors. The protocol specified measurements of body weight, body mass index, fasting blood sugar, HbA1c-a measure of average blood sugar-and liver enzymes before treatment and after 12 weeks. Blood fats, including cholesterol and triglycerides, and the ultrasound grade of liver fat were also included. Follow-up visits were scheduled every four weeks to assess medication use and record side effects. The planned analysis compared changes from baseline between the two treatment groups.

Official title: Effect of Dapagliflozin on Metabolic Parameters in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Controlled Trial

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