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 — DRUG
    name and concentration of drug ( Dapagliflozin 10 mg)
  • Empa — DRUG
    name 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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