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ACTIVE NOT RECRUITING
NCT07020377
PHASE1/PHASE2

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

Sponsor: Amira Bisher,PhD

View on ClinicalTrials.gov

Summary

Nonalcoholic fatty liver disease (NAFLD) encompasses conditions such as nonalcoholic steatohepatitis (NASH), which involves liver inflammation and fibrosis resulting from steatosis, potentially leading to cirrhosis and hepatocellular carcinoma. NAFLD is intricately linked to metabolic syndrome, with insulin resistance and hyperinsulinemia as key underlying factors. particularly among individuals with type2 diabetes. NAFLD is an independent risk factor for cardiovascular events, negatively impacting life expectancy in diabetic patients, and it exacerbates insulin resistance and glucose intolerance. Early intervention in diabetes complicated by NAFLD is vital due to associations with hepatocarcinogenesis and macrovascular complications. Sodium-glucose cotransporter2 (SGLT2) inhibitors, which promote glucose excretion and reduce insulin dependence, have shown significant hypoglycemic effects, weight reduction, and potential benefits on liver function. Dapagliflozin, a specific SGLT2 inhibitor, has been proven effective in lowering hyperglycemia in type 2 diabetes and mitigating NAFLD-related complications in animal models. This study aimed to evaluate the impact of dapagliflozin on liver function in NAFLD patients with type2 diabetes. Eligible participants received dapagliflozin for 24weeks, with assessments including body composition, serum biochemistry, and molecular parameters to determine therapeutic outcomes.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-01-15

Completion Date

2025-12-30

Last Updated

2025-06-13

Healthy Volunteers

No

Interventions

DRUG

Dapagliflozin (DAPA)

dapagliflozin 10mg tab once daily for NAFLD patient

DRUG

Placebo

placebo

OTHER

Negative control

Baseline sample serum without either drug or placebo

Locations (2)

Egyptian liver hospital

Al Mansurah, Egypt

Alexandria university main hospital

Alexandria, Egypt