NCT04910178

Follow-up of NAFLD Patients With MRI-PDFF

Evaluating the Effect of Pentoxifylline, Ursodiol, and Empagliflozin on Fatty Liver of Patients With Type-2 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Asmaa Abdelfattah Elsayed · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The liver is a key organ in metabolism and contributes to T2DM development and insulin resistance via unclear mechanisms that may involve liver fat accumulation, inflammatory signals, and immune cells are proposed to play an important role in the pathogenesis of both NAFLD and T2DM.

Detailed description

This study aims to define * The effects of PTX, Empagliflozin as an example of SGLT-2 inhibitors and UDCA on liver biomarkers and liver steatosis in type 2 diabetic patients. * Studying PTX, Empagliflozin as an example of SGLT-2 inhibitors and UDCA efficacy and safety as add-on therapy in type 2 diabetic patients.

Conditions

• Diabetes Type 2
• NAFLD

Interventions

Type	Name	Description
DRUG	Empagliflozin 25 MG	tablets to be taken orally once a day
DRUG	Ursodeoxycholic acid	tablets to be taken orally twice a day
DRUG	Pentoxifylline 400 MG	tablets to be taken orally twice a day
OTHER	placebo	just starch tablets without any active agents

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-30
• First posted: 2021-06-02
• Last updated: 2022-12-20

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study