Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Serum concentration of YKL-40
研究概览
简要总结
Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria for diagnosis of diabetes
排除标准
- •positive history for taking anti-diabetes medications of any class in the past
- •positive current history for taking over-the-counter vitamin or anti-oxidant supplements
- •presence of clinically significant chronic illnesses of the heart, lungs, or kidneys.
研究组 & 干预措施
Metformin
patients receiving fixed dose metformin 1000 mg daily
干预措施: Metformin (Drug)
Pioglitazone
patients receiving fixed dose pioglitazone 30 mg daily
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Serum concentration of YKL-40
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Alireza Esteghamati
Professor Alireza Esteghamati
Tehran University of Medical Sciences
