Efficacy of Vildagliptin, Liraglutide and Empagliflozin in the Management of Fatty Liver Disease Among Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in steatosis as measured using CAP score (fibroscan) and MRI
研究概览
简要总结
Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease.
Study setting: Randomized controlled trial
Study population:
Patients with type 2 DM plus Fatty Liver.
Arms and Interventions
- Experimental arms: Group 1: metformin +/- insulin +/- sulfonylurea Group 2: Metformin plus vildagliptin+/- insulin +/- sulfonylurea Group 3: Metformin plus liraglutide+/- insulin+/- sulfonylurea Group 4: Metformin plus empagliflozin +/- insulin +/- sulfonylurea
详细描述
Rational: Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease.
Study setting: Randomized controlled trial
Study population:
Patients with type 2 DM plus Fatty Liver.
NAFLD diagnostic criteria:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 DM with fatty liver disease.
- •HbA1C less than 10.
排除标准
- •Alcohol intake.
- •BMI 40 or more.
- •CKD with e GFR less than
- •chronic liver diseases (chronic viral hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alfa-1 antitrypsin deficiency)
- •Atherosclerotic cardiovascular disease.
- •Celiac disease.
- •Clinically evident liver cirrhosis.
- •Patients who have ever had medullary thyroid carcinoma (MTC) or who have a family member who has ever had and patients who have multiple endocrine neoplasia syndrome type 2 (MEN 2)
研究组 & 干预措施
Group 1
metformin +/- insulin +/- sulfonylurea
干预措施: Metformin (Drug)
Group 2
Metformin plus vildagliptin +/- insulin +/- sulfonylurea
干预措施: Metformin (Drug)
Group 3
Metformin plus liraglutide +/- insulin+/- sulfonylurea
干预措施: Metformin (Drug)
Group 4
Metformin plus empagliflozin +/- insulin +/- sulfonylurea
干预措施: Metformin (Drug)
结局指标
主要结局
Change in steatosis as measured using CAP score (fibroscan) and MRI
时间窗: 12 months
次要结局
- Change in liver enzymes(12 months)
- Changes in fibrosis grade(12 months)
研究者
Ahmed Kamal
Lecturer
Alexandria University