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Clinical Trials/NCT06739486
NCT06739486
Not yet recruiting
Not Applicable

Efficacy of Sodium Glucose Cotransporter 2 Inhibitors on Non-Alcoholic Fatty Liver Disease

Assiut University0 sites100 target enrollmentDecember 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non Alcholic Fatty Liver Disease
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
determine the effects of dapagliflozin, an SGLT2 inhibitor, on hepatic fibrosis and steatosis in patients with NAFLD using fibroscan and biomarkers
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

evaluate the effectiveness of sodium-glucose cotransporter-2 (SGLT.2) inhibitors in improving hepatic steatosis and hepatic fibrosis using imaging biomarkers and histopathology in patients with non-alcoholic fatty liver disease

Detailed Description

2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.) Non-alcoholic fatty liver disease (NAFLD) is a leading cause of liver-related health issues worldwide, with prevalence rates reaching up to 30%.The number of cases has been steadily rising, increasing from 391.2 million in 1990 to 882.1 million in 2017. NAFLD is often linked to one or more components of metabolic syndrome, such as hypertension, dyslipidemia, obesity, and Type 2 diabetes mellitus, along with insulin resistance. Although the exact pathogenesis of NAFLD is not fully understood, there is increasing evidence that insulin resistance and lipid metabolism dysregulation play significant roles in the development of hepatic steatosis. Factors such as a high-fat diet, insulin resistance, obesity, and dysregulated peripheral lipolysis contribute to the increased influx of free fatty acids into the liver, leading to a 'lipotoxic' state within hepatocytes.The accumulation of triacylglycerol in the cytoplasm of hepatocytes manifests histologically as steatosis. Persistent micro-hepatic injury eventually results in endoplasmic reticulum stress and mitochondrial dysfunction, which then contribute to lobular inflammation, cellular apoptosis, and hepatic fibrosis over time. If left untreated, this manageable condition can lead to serious complications, including advanced cirrhosis, hepatocellular carcinoma, and potentially cardiovascular morbidity.and mortality.Given the serious prognostic implications of NAFLD, effective treatment is essential to prevent disease progression. While weight loss and lifestyle modifications are the primary treatments, pharmacologic options remain limited. Recently, the potential of a novel oral hypoglycemic agent known as sodium-glucose cotransporter 2 (SGLT-2) inhibitors in the treatment of NAFLD has been explored through various animal studies on rodent models and human clinical trials, showing promising effects.

Registry
clinicaltrials.gov
Start Date
December 20, 2024
End Date
December 20, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdallah Gamal Eldin Shawky Mohamed Hamad

Internal resident

Assiut University

Eligibility Criteria

Inclusion Criteria

  • age \>18 years

Exclusion Criteria

  • alcohol drinker
  • any cause of liver affection (hepatitis, autoimmune...etc)
  • patients with kidney function affection

Outcomes

Primary Outcomes

determine the effects of dapagliflozin, an SGLT2 inhibitor, on hepatic fibrosis and steatosis in patients with NAFLD using fibroscan and biomarkers

Time Frame: Baseline

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