Comparison of The Effects of Thiazolidinediones(TZD), Sodium- Glucose Cotransporter 2 Inhibitors(SGLT2i) Alone and TZD / SGLT2i Combination Therapy on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients With Fatty Liver
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in liver fat fraction (%) measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver
研究概览
简要总结
To investigate the synergic therapeutic effect of thiazolidinediones and SGLT2 inhibitor on nonalcoholic fatty liver disease, the effect of empagliflozin 10mg, pioglitazone 15mg monotherapy and combination therapy n patients with type 2 diabetes and fatty liver will be compared and analyzed.
This study included a total of 60 patients (20 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials.
The drug will be maintained for a total of six months. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in co-localized regions of interest within nine liver segments between three groups.
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
盲法说明
open label
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 19 to 75 years
- •Individuals who are diagnosed with type 2 diabetes (HbA1c ≥ 7.5% and < 11.0%) and treated with antidiabetic drugs excluding TZD and SGLT2i over the previous 12 weeks
- •Individuals diagnosed with steatotic liver disease as documented by abdominal ultrasonography within the previous year
- •Individuals who have voluntarily agreed in written form to participate in the clinical trial after hearing the explanation of this clinical trial
- •Individuals who understand the content of the clinical trial and are able to participate in the trial until the end of the clinical trial
排除标准
- •Type 1 diabetes and gestational diabetes
- •Highly uncontrolled diabetes (HbA1c ≥ 11.0%)
- •Excessive alcohol intake (210 g and 140 g/week for men and women, respectively) within the previous 2 years
- •A history of taking thiazolidinedione or sodium-glucose cotransporter 2 inhibitor class medications within the last 12 weeks, or a history of discontinuing these medications due to severe side effects
- •Treatment with four or more classes of antidiabetic medications
- •Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, within 24 weeks
- •Intake of drugs that can cause steatotic liver disease (amiodarone, methotrexate, tamoxifen, valproate, etc.)
- •Allergy or hypersensitivity to the study drugs or their constituents
- •Oral or parenteral chronic corticosteroid therapy (more than 14 consecutive days) that requires continual adjustments in corticosteroid dose for therapeutic purposes within 8 weeks
- •Galactosemia
- •Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Malignant tumors currently undergoing treatment or progression
- •A history of substance abuse or alcohol intoxication within 12 weeks
- •Infection of human immunodeficiency virus
- •Severe infection
- •Pre- and post-operative status, or severe trauma
- •Cardiac failure within 24 weeks (class III to IV in the NYHA classification)
- •Acute cardiovascular event within 12 weeks (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or coronary intervention)
- •AAcute and chronic renal disease (estimated glomerular filtration rate < 45 mL/min/1.73 m²) or dialysis
- •Pregnant or lactating women
- •Individuals whom the investigator determines to be unsuitable for participation in the clinical trial
研究组 & 干预措施
Pioglitazone monotherapy
Pioglitazone 15mg 1T daily for 24 weeks
干预措施: Pioglitazone (Drug)
Empagliflozin monotherapy
Empagliflozin 10mg 1T daily for 24 weeks
干预措施: Empagliflozin (Drug)
Pioglitazone + Empagliflozin combination therapy
Pioglitazone 15mg 1T + Empagliflozin 10mg 1T combination daily for 24 weeks
干预措施: Combination of pioglitazone and empagliflozin (Drug)
结局指标
主要结局
Change in liver fat fraction (%) measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver
时间窗: After 24 weeks of treatment
To measure the fat fraction, we drew the largest possible polygonal region of interest encompassing both lobes of the liver on a cross-sectional image, while avoiding blood vessels, bile ducts, and distinct hepatic lesions.
次要结局
- Liver fibrosis measured by magnetic resonance elastography(After 24 weeks of treatment)
- The changes in lipid profile(After 24 weeks of treatment)
- The changes in liver enzyme(After 24 weeks of treatment)
- The changes in glucose metabolism(After 24 weeks of treatment)
- The changes in cytokines(After 24 weeks of treatment)
- The changes in other biochemical parameters(After 24 weeks of treatment)
- The changes in blood pressure and anthropometric parameters(After 24 weeks of treatment)
- The changes in body composition(After 24 weeks of treatment)