A Study Between Dapagliflozin and Empagliflozin Effect on NAFLD in Patients With Type 2 Diabetes.
- Sponsor
- Beni-Suef University
- Study ID
- NCT07363707
- Phase
- PHASE4
- Status
- Completed
Conditions
- NAFLD (Nonalcoholic Fatty Liver Disease)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin + Metformin — DRUGname and concentration of drug ( Dapagliflozin 10 mg)
- Empa — DRUGname and concentration of drug Empagliflozin 25
Study Details
The goal of this clinical trial is to learn if drugs Dapagliflozin and Empagliflozin work to treat NAFLD in Type 2 diabetes patients. It will also learn about the safety of drugs dapagliflozin and empagliflozin. The main questions it aims to answer are: Do drug dapagliflozin and empagliflozin lower the NAFLD degree for participants? What medical problems do participants have when taking the drugs dapagliflozin and empagliflozin? Researchers will compare drug dapagliflozin to empagliflozin to see which of them more effective to treat NAFLD. Participants will: Take drug dapagliflozin or empaglifloin every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Key Dates
- Start date
- May 1, 2023
- Status verified
- Dec 2025
- Primary completion
- Aug 27, 2023
- Completion
- Mar 1, 2024
Study Design
- Enrollment
- 108 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Dapagliflozin
- Active Comparator: Empagliflozin
Primary Outcome Measure
Fibro scan, as well as the changes in FIB4 score and Full lipid profile (total cholesterol, LDL, HDL, VLDL, and triglyceride). [ Time Frame: at zero month and after 6 six months ]
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