Assessment of Efficacy of Empagliflozin Versus Statins in Treatment of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The controlled attenuation parameter (CAP).
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of Empagliflozin versus Statins as monotherapy and polytherapy in non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis.
Does drug ABC Empagliflozin versus Statins as monotherapy and polytherapy improve the controlled attenuation parameter (CAP), the liver stiffness measurement (LSM), the proportion of patients with at least one point improvement or one-stage reduction in the histological scores with respect to hepatic steatosis, hepatocellular ballooning, lobular inflammation, and fibrosis after treatment?
What medical problems do participants have when taking Empagliflozin versus Statins as monotherapy and polytherapy?
Participants will:
- Take Empagliflozin alone or Empagliflozin plus statins or Pioglitazone plus Statins or Pioglitazone alone as standard therapy every day for 3 months
- Be directed to complete history taking. FibroScan®, abdominal ultrasound and laboratory tests of ALT, AST, ALP, platelets count, Triglycerides, Cholesterol, LDL, HDL, serum insulin and insulin resistance will be conducted at baseline and after the drug administration for 3 months.
- Keep a diary of recording any side effects they use a rescue inhaler
详细描述
NAFLD is a growing global health problem linked with metabolic issues like obesity, diabetes, and insulin resistance. It ranges from simple liver fat accumulation to NASH, involving inflammation and liver damage, progressing to fibrosis, cirrhosis, and cancer. Managing NAFLD is tough due to diagnosis challenges and metabolic complications. Lifestyle changes like diet and exercise are key but often hard to sustain. No FDA-approved treatments exist yet, but drugs like Empagliflozin and statins are being studied for their potential to improve insulin sensitivity, reduce liver inflammation, and slow disease progression. This study compares these therapies for NAFLD and NASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Hyperlipidemic
- •Diabetic patients
- •Diagnosed with non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis
排除标准
- •Pregnant women
- •Breast feeding women
- •Diabetic patients with ketoacidosis
- •Hyperlipidemic patients with cardiovascular dysfunction
- •Patients with NAFLD or NASH induced hepatocellular carcinoma
- •Hyperlipidemic obese diabetic patients diagnosed with NAFLD or NASH who will refuse to sign the informed consent
研究组 & 干预措施
Statins
Once daily orally for 3 months
干预措施: Statin (Atorvastatin) (Drug)
Empagliflozin plus statins
Once daily orally for 3 months
干预措施: Empagliflozin plus Statin (Atorvastatin) (Drug)
Pioglitazone plus Statins
Once daily orally for 3 months
干预措施: Pioglitazone plus Atorvastatin (Drug)
Pioglitazone
30 mg once daily orally for 3 months
干预措施: Pioglitazone (PIO) (Drug)
Empagliflozin
10 mg once daily orally for 3 months
干预措施: Empagliflozin (Drug)
结局指标
主要结局
The controlled attenuation parameter (CAP).
时间窗: After 3 months
The CAP value is expressed in dB/m.
The liver stiffness measurement (LSM) using FibroScan®.
时间窗: After 3 months
The LSM value is expressed as kilopascal or kPa.
次要结局
- Fibrosis-4 (FIB-4) index(After 3 months)
研究者
Eman Said Sawan
Lecturer
Badr University