NCT05459701

Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Rehab Werida · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM.

Detailed description

1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. 2. Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes. 3. About 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on non- alcoholic fatty disease, will be recruited from Alexandria Teaching Hospital (EL-Mery), General Organization for Teaching Hospitals and Institutes. 4. All participants should agree to take part in this clinical study and will provide informed consent. 5. Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected. 6. Venous blood samples (5 ml will be collected by a sterile syringe then placed in a suitable sterile tube to be centrifuged, the serum will be reserved and stored at -80°C until the analysis) before, and after receiving medication (Dapagliflozin). 7. Measuring outcome: 1. The biochemical tests will be done on the patients are alanine aminotransferase (ALT), aspartate aminotransferase (AST), homeostasis model assessment of insulin resistance (HOMA-IR), Hemoglobin A1C (HbA1C), Low-density lipoproteins (LDL), High-density lipoproteins (HDL), Triglycerides (TG), liver fibrosis score, and complete blood count (CBC). 2. The molecular tests will be done on the patient are soluble vascular cell adhesion molecule-1 (Svcam-1), adipocytes (e.g. adiponectin, leptin). 8. The ultrasound screening will be done at first examination. 9. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 10. Results, conclusion, discussion and recommendations will be given.

Conditions

• Nonalcoholic Fatty Liver Disease
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg Tab	Dapagliflozin 10 mg once daily for 24 weeks.
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-06-30
• Completion: 2024-07-31
• First posted: 2022-07-15
• Last updated: 2025-02-04

Locations

1 site across 1 country: Egypt