Effect of Dulaglutide vs Empagliflozin on Non-alcoholic Fatty Liver Disease of Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Liver Fat Fraction reduction
研究概览
简要总结
The goal of this clinical study is to compare the therapeutic effect of Dulaglutide and Empagliflozin in patients with Diabetes Mellitus type 2 and Non-Alcoholic Fatty Liver Disease. The main question it aims to answer is: Is there a beneficial effect regarding liver steatosis in patients receiving either of these 2 medications and which is more effective? Patients will undergo shearwave elastography, magnetic resonance imaging, and ultrasound. Furthermore, calculation of the Fatty Liver Index (FLI), the Fibrosis-4 Index (FIB-4), as well as the Aspartate Aminotransferase to Platelet ratio Index (APRI) and the NAFLD Fibrosis Score (NFS) will be performed.
Researchers will compare 3 groups:
Group 1 will receive oral Empagliflozin, as add-on to their previous treatment regimen, for 52 weeks.
Group 2 will receive subcutaneous Dulaglutide, as add-on to their previous treatment regimen, for 52 weeks.
Group 3 will receive other optimal antidiabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families) for 52 weeks.
详细描述
Rationale:
NAFLD is the most common chronic liver disease worldwide. Presently, relative clinical guidelines focus on weight loss through apporopriate diet and lifestyle. The Glucagon-Like Peptide 1 receptor agonists and the Sodium-Glucose Co-transporter 2 inhibitors constitute novel agents that seem to exert beneficial effects beyond glycemic control. Dulaglutide will be used from the GLP1-ras family and Empagliflozin from the SGLT2-is family.
Research question:
Is the use of Empagliflozin or Dulaglutide effective in improving liver fat fraction in patients with type 2 diabetes mellitus and NAFLD? Which is more beneficial?
Hypothesis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of diabetes mellitus type 2 and non-alcoholic fatty liver Stable anti-diabetic treatment regimen for the past 6 months
排除标准
- •Recent (last 5 years) medical history of cancer, pancreatitis, viral hepatitis or any other cause of liver disease (alcohol abuse, autoimmune hepatitis, hemochromatosis, heart failure etc.) Recent alteration (<6 months) of anti-diabetic regimen. Already established treatment with GLP1-ras or SGLT2-is prior to screening. Treatment with Pioglitazone. Corticotherapy administration. Pregnant or planning for pregnancy.
研究组 & 干预措施
Empagliflozin group
Oral Empagliflozin 10mg daily, as add-on to their previous treatment regimen.
干预措施: Empagliflozin (Drug)
Dulaglutide group
Subcutaneous Dulaglutide 1.5mg weekly, as add-on to their previous treatment regimen.
干预措施: Dulaglutide (Drug)
Control group
Optimal anti-diabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families), targeting glycemic control.
干预措施: Control Rx (Drug)
结局指标
主要结局
Liver Fat Fraction reduction
时间窗: 52 weeks
Change of Liver Fat Fraction as calculated by MRI-PDFF
>30% Liver Fat Fraction reduction
时间窗: 52 weeks
Percentage of each group's participants that achieves \>30% Liver Fat Fraction reduction
次要结局
- HbA1c change(52 weeks)
- Body Mass Index change(52 weeks)
- Fatty Liver Index (FLI)(52 weeks)
- Aspartate Aminotransferase to Platelet ratio Index (APRI)(52 weeks)
- Fibrosis-4 Index (FIB-4)(52 weeks)
- NAFLD Fibrosis Score (NFS)(52 weeks)
- Shearwave Elastography (SWE)(52 weeks)
研究者
KOULLIAS EMMANOUIL
INTERNIST
National and Kapodistrian University of Athens