NCT05942963

Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD

PEARL-DM: Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD; Randomized Controlled Trial From Pakistan.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Jinnah Postgraduate Medical Centre · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will yield results about the therapeutic effect of combining pioglitazone with SGLT2i in people suffering from NAFLD associated with T2DM. Study participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to their health. In addition, some blood tests will be done following standard procedures.

Detailed description

This is a randomized clinical trial conducted to compare the efficacies of pioglitazone and empagliflozin in people suffering from NAFLD associated with T2DM. Randomization will be done using card randomization. Four different color-coded cards will be kept. Any card will be randomly picked for the patient fulfilling inclusion criteria and will be treated according to the allocated treatment arm mentioned on the card Written informed consent will be obtained from the immediate attendant of the patient. All ethical considerations will be followed. Our research has been approved by Jinnah Sindh Medical University, Karachi. For this approval, the investigators have made every effort to ensure the confidentiality of research data collected from all our participants in this survey. The information collected will be stored with the investigators only in the form of de-identified information and will be retained in a secure place under lock and key. Any results that will be generated will be presented on a collective basis, and will not contain the participants name or any other personal details. Data entry and analysis will be done using SPSS Software version 23. Study analysis will be done using the principle of intention to treat. The mean scores will be compared pre and post-intervention using paired t-test. The association of age, gender, and grade of fatty liver will be compared with different groups using correlation and regression models. All analyses will be at a confidence Interval of 95% and a p-value \<.05.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Type2diabetes

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 MG	10-25 mg/day
DRUG	Pioglitazone 15mg	15-45 mg/day
DRUG	Metformin	1000mg-2850mg/ day

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-07-12
• Last updated: 2023-07-12

Locations

1 site across 1 country: Pakistan