NCT04910178已完成4 期
Evaluating the Effect of Pentoxifylline, Ursodiol, and Empagliflozin on Fatty Liver of Patients With Type-2 Diabetes
Asmaa Abdelfattah Elsayed1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- liver fat content (percent)
研究概览
简要总结
The liver is a key organ in metabolism and contributes to T2DM development and insulin resistance via unclear mechanisms that may involve liver fat accumulation, inflammatory signals, and immune cells are proposed to play an important role in the pathogenesis of both NAFLD and T2DM.
详细描述
This study aims to define
- The effects of PTX, Empagliflozin as an example of SGLT-2 inhibitors and UDCA on liver biomarkers and liver steatosis in type 2 diabetic patients.
- Studying PTX, Empagliflozin as an example of SGLT-2 inhibitors and UDCA efficacy and safety as add-on therapy in type 2 diabetic patients.
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
- Single (Outcomes Assessor)
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
- •Patients who are willing to participate in this study
- •Adults aged ≥ 18 years old presented at the clinic with a confirmed diagnosis of T2DM who are on sulfonylurea for the last 6 months at least and diagnosed with NAFLD.
排除标准
- •• Patients who refused to participate in this trial
- •Patients diagnosed with Type 1 diabetes
- •Previous history of alcohol intake
- •history of recurrent attacks of ketoacidosis in a diabetic patient
- •Type 2 diabetic patient with kidney dysfunction (estimated eGFR below 60ml/min/1.73m2 or CrCl below 60ml/min) or on dialysis
- •Previous history of taking medication that may alter either drug efficacy (eg, corticosteroids, oral contraceptives, and thiazide diuretics)
- •Evidence of another liver disease (viral hepatitis, drug-induced liver disease, autoimmune hepatitis)
- •Lactating/pregnant female or children ≤ 18
- •Any contraindication for Empagliflozin including:
- •History of recurrent attacks of UTI or Genital infection in females
- •History of recurrent foot injuries or infections
- •Type 2 diabetic patient with CV disease especially NYHA classes III/ IV
- •Immunocompromised patients or with a history of inflammatory, immunological, or malignant diseases.
- •Any contraindication for PTX including:
- •Hypersensitivity to PTX
- •Patients with peptic ulcer disease or tendency for bleeding
- •Any contraindication for UDCA including:
- •Hypersensitivity to UDCA
- •Patients with biliary disease or hepatobiliary disease (ascites, jaundice)
- •Patients with hepatic encephalopathy or gallstone pancreatitis
研究组 & 干预措施
Empa group
Experimental
patients will be given Empagliflozin 25 mg once daily
干预措施: Empagliflozin 25 MG (Drug)
PTX group
Experimental
patients will be given PTX 400 mg twice daily or 3 times daily
干预措施: Pentoxifylline 400 MG (Drug)
UDCA group
Experimental
patients will be given UDCA 500 mg twice daily
干预措施: Ursodeoxycholic acid (Drug)
Placebo
Placebo Comparator
patients will be given a placebo
干预措施: placebo (Other)
结局指标
主要结局
liver fat content (percent)
时间窗: 6-months
measured by MRI-PDFF
fatty liver staging (0, I, II, and III)
时间窗: 6-months
using ultrasound
次要结局
- Changes in Serum Gamma glutamyl transferase (γ-GT)(6-months)
- HbA1c (%)(6-months)
- Fasting and 2-hr post-prandial serum glucose (mg/dl)(6-months)
- Lipid profile(6-months)
- Changes in liver enzymes(6-months)
- Changes in direct and total bilirubin(6-months)
- Changes in total protein and albumin(6-months)
研究者
Asmaa Abdelfattah Elsayed
PHD candidate in clinical pharmacy department and PI
Beni-Suef University
研究点 (1)
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