Comparison Between the Effect of Aspirin, Metformin, and SGLT2 Inhibitor Intake in Non-Alcoholic Fatty Liver on Liver Enzymes, Lipid Profile, and the Results of FibroScan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- lipid profile and Fibroscan results
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), is a common hepatic manifestation of metabolic dysfunction and may progress from simple steatosis to steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma.
This randomized clinical trial evaluated and compared three pharmacological approaches with different mechanisms of action: low-dose aspirin as an anti-inflammatory and antiplatelet therapy, dapagliflozin as a sodium-glucose cotransporter-2 (SGLT2) inhibitor with metabolic effects, and metformin as an insulin-sensitizing therapy.
The study assessed their effects on liver enzymes, lipid profile, and FibroScan-derived measures of hepatic steatosis and liver stiffness over a 6-month treatment period.
详细描述
This was a single-center, open-label, parallel-group randomized controlled clinical trial conducted over 6 months in adults diagnosed with non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD).
Participants were randomly allocated to one of three treatment groups:
- Aspirin group: aspirin 100 mg orally once daily for 6 months.
- Dapagliflozin group: dapagliflozin 10 mg orally once daily for 6 months.
- Metformin group: metformin 1000 mg orally once daily for 6 months.
The study was designed to compare the hepatic and metabolic effects of anti-inflammatory/antiplatelet therapy, SGLT2 inhibition, and insulin-sensitizing therapy in patients with NAFLD/MASLD.
Participants underwent clinical and laboratory assessment at baseline and after 6 months of treatment. Laboratory assessments included liver enzymes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP), together with lipid-profile parameters, including total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •if one or more the following are present:
- •Diabetes mellitus, unless receiving only Dapagliflozin for treatment.
- •Adult individuals (18-65 years) with a clinical diagnosis of NAFLD based on liver ultrasound
- •No history of alcohol consumption or consumption within 3 months.
- •Absence of other liver diseases.
- •No significant renal or gastrointestinal issues that could interfere with treatment.
排除标准
- •Patients were excluded from our study if one or more the -following are present:
- •Pregnancy or breastfeeding.
- •Active chronic viral hepatitis or autoimmune liver disease.
- •History of gastrointestinal bleeding or other contraindications for Aspirin.
- •Severe renal insufficiency.
- •Alcohol intake
研究组 & 干预措施
aspirin group
Participants were received 100 mg of aspirin as oral daily doses for 6 months.
干预措施: Aspirin (Drug)
Metformin group
Participants received metformin 1000 mg orally once daily for 6 months.
干预措施: Metformin 1000 mg (Drug)
Dapagliflozin group
Participants were received 10 mg of dapagliflozin as oral once-daily doses for 6 months.
干预措施: Dapagliflozin (10Mg Tab) along with standard medical therapy (Drug)
结局指标
主要结局
lipid profile and Fibroscan results
时间窗: 6 months
* Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months. * Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months. * Fibroscan results (liver stiffness measurement) at baseline and after 6 months.
lipid profile and Fibroscan evalution
时间窗: 6 months
* Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months. * Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months. * Fibroscan results (liver stiffness measurement) at baseline and after 6 months.
次要结局
- indicators of metabolic improvement(6 months)
研究者
Eman Hamed
Lecturer of Clinical Pharmacy
Galala University