Clinical trial NCT06739486: Efficacy of Sodium Glucose Cotransporter 2 Inhibitors on Non-Alcoholic Fatty Liver Disease
Official title: Efficacy of Sodium Glucose Cotransporter 2 Inhibitors on Non-Alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non Alcholic Fatty Liver Disease
Hepatic Steatosis
Hepatic Fibrosis
NAFLD (Nonalcoholic Fatty Liver Disease)
Keywords: NAFLD
Non alcoholic fatty liver disease
Hepatic steatosis
Hepatic fibrosis
Na glucose cotransporter 2 inhibitors
SGLT-2 inhibitors
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged over 18 years, not alcohol drinker,has any cause of liver affection,or with kidney function affection

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.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* both sex

Exclusion Criteria:

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

Primary outcomes:
measure: determine the effects of dapagliflozin, an SGLT2 inhibitor, on hepatic fibrosis and steatosis in patients with NAFLD using fibroscan and biomarkers
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Abdallah A Gamal, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Lobna A Farag, Lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed A Abozaid, Lecturer
role: STUDY_DIRECTOR
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