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NCT Number: NCT06739486

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

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

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age >18 years
  • both sex

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Abdallah A Gamal, Resident

CONTACT

[email protected]

01153381807

Lobna A Farag, Lecturer

CONTACT

[email protected]

01005571004

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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