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

Dapagliflozin in NAFLD

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

2022-05-01

2024-04-30

2024-05-10

Recruiting

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized (1:1), double-blind clinical trial, will be carried out on 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on diabetic type 2 patients with non- alcoholic fatty disease (dapagliflozin 10 mg once daily for 24 - 48 weeks\n\n-Patients will be randomly allocated into two equal groups (25 patients each); group (A) for controlled (placebo), and the other group (D) for Dapagliflozin.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-02-21