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

Phase 4

Completed

• Conditions: Nonalcoholic Fatty Liver Disease; Type 2 Diabetes
• Interventions: Drug: Dapagliflozin 10mg Tab; Other: Placebo

• Registration Number: NCT05459701
• Lead Sponsor: Rehab Werida

Brief 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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-15
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Type 2 diabetes mellitus patients.
2. HbA1C < 8.5.
3. Patients were They were having fatty liver changes on abdominal ultrasound and mild to moderate elevation of serum liver enzymes.
4. BMI more than 30

Exclusion Criteria

1. Patients with a history of alcohol, smoking, uncontrolled diabetes.
2. (HbA1c > 9.0).
3. Pregnancy.
4. Lactation.
5. Hemochromatosis.
6. Thyroid disorders.
7. Renal dysfunction.
8. Cardiac problem.
9. Chronic liver and decompensated liver disease in the form of hepatitis B and C.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group (D) for Dapagliflozin.	Dapagliflozin 10mg Tab	25 patients will recieve 10 mg Dapagliflozin daily for 6 months.
group (A) for controlled (placebo).	Placebo	25 patients will recieve placebo for 6 months.

Primary Outcome Measures

Name	Time	Method
leptin (ng/ml)	6 months	leptin by enzyme-linked immunosorbent assay (ELISA).
adiponectin (pg/ml)	6 months	adiponectin by enzyme-linked immunosorbent assay (ELISA).
VCAM-1 (ng/ml)	6 months	VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.

Trial Locations

Locations (1)

Rehab Hussein Werida; 🇪🇬 Damanhūr, Elbehairah, Egypt