Effects of Empagliflozin in Reducing Oxidative Stress of Diabetic Recipients After Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- serum level of superoxide dismutase
研究概览
简要总结
The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes after kidney transplantation. The association is examined by comparing the difference in oxidative modifications before and after 90 days treatment with 25 mg empagliflozin plus insulin compared to insulin treatment. The study is randomised and double-blinded. Each treatment group consists of 20 patients. Oxidative stress markers are measured by serum level of superoxide dismutase activity ,lipid peroxidation assay kit, glutathione assay, glutathione peroxidase activity , total antioxidant capacity assay oxidant status , carbonyl content assay and bca protein assay . . A student t-test will be performed to compare adding empagliflozin . The results will be published in a peer-review journal.
详细描述
With the purpose of studying the antioxidant activity of empagloflozin 25mg will add on insulin in 20 patients after kidney transplant and will compare with 20 diabetic recipient of kidney transplant on insulin therapy alone.
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
- Double (Participant, Investigator)
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
- •Diagnosed with type 2 diabetes
- •HbA1c: 6.5-9.0%
- •post kidney transplant
- •stable graft function
排除标准
- •pancreas and kidney transplant
- •history of recurrent urinary tract infection
研究组 & 干预措施
Empagliflozin
Adding 25mg Empagliflozin on Insulin
干预措施: Empagliflozin 25 MG (Drug)
Empagliflozin
Adding 25mg Empagliflozin on Insulin
干预措施: Insulin (Drug)
Insulin alone
Just contriling the blood glucose with Insulin
干预措施: Insulin (Drug)
结局指标
主要结局
serum level of superoxide dismutase
时间窗: Change from baseline after 90 days of intervention
Serum level of antioxidant levels
次要结局
- Plasma levels of malondialdehyde(Change from baseline after 90 days of intervention)
研究者
nooshin dalili
Assistant Professor of SBMU
Shahid Beheshti University of Medical Sciences