EMPOX - A Randomised, Double-blinded, Placebo Controlled Study That Evaluates the Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)
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. The association is examined by comparing the difference in oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and 8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment with placebo. The results will be published in a peer-review journal.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes
- •HbA1c: 6.5-9.0%
- •Capable of understanding oral- and written information
- •Caucasian
排除标准
- •Estimated glomerular filtration rate (eGFR) < 60 mL/hour/1.73 m2
- •Currently receiving insulin treatment
- •Coronary artery bypass grafting, percutaneous coronary intervention, acute coronary syndrome, stroke, lung embolism, deep vein thrombosis, or transitory cerebral ischemia within 6 months
- •Genital infection within 14 days
- •Plasma alanine aminotransferase ≥3 times upper normal limit
- •Treatment with sodium glucose cotransporter (SGLT) -2 inhibitor within 2 months
- •Hyperglycaemic symptoms
- •Psychiatric disorder
- •Intolerance to empagliflozin or other agents relevant to study
- •Non-compliant
研究组 & 干预措施
Empagliflozin
One tablet 25 mg empagliflozin every morning for 14 days
干预措施: Empagliflozin (Drug)
Placebo
One tablet placebo every morning for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)
时间窗: Change from baseline after fourteen days of intervention
Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h)
时间窗: Change from baseline after fourteen days of intervention
次要结局
- Plasma levels of malondialdehyde(Change from baseline after fourteen days of intervention)
- Plasma levels of iron, ferritin, transferrin and transferrin saturation(Measured at baseline and after intervention)
研究者
Henrik Enghusen Poulsen
Professor, DMSc, chief physician
Rigshospitalet, Denmark