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临床试验/NCT01963663
NCT01963663已完成不适用

Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

patients receiving fixed dose metformin 1000 mg daily

干预措施: Metformin (Drug)

Pioglitazone

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alireza Esteghamati

Professor Alireza Esteghamati

Tehran University of Medical Sciences

研究点 (1)

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