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

Rehab Werida

Status and phase: Completed; Phase 4

Conditions: Nonalcoholic Fatty Liver Disease; Type 2 Diabetes

Treatments: Drug: Dapagliflozin 10mg Tab; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05459701

Dapagliflozin in NAFLD

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

group (A) for controlled (placebo).

Placebo Comparator group

Description:

25 patients will recieve placebo for 6 months.

Treatment:

Other: Placebo

group (D) for Dapagliflozin.

Active Comparator group

Description:

25 patients will recieve 10 mg Dapagliflozin daily for 6 months.

Treatment:

Drug: Dapagliflozin 10mg Tab