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临床试验/NCT01521624
NCT01521624已完成不适用

Comparing Effects of Metformin Plus Life Style Modification Compared With Life Style Modification Alone in Lowering Parameters of Oxidative Stress in Newly Diagnosed Type 2 Diabetes Patients

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2010年10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
108
试验地点
1
主要终点
Serum concentrations of various markers of oxidative stress

研究概览

简要总结

Oxidative stress plays a key role in the pathogenesis of diabetes complications. Chronic hyperglycemia and disturbed lipid regulation commonly seen in diabetes are the main causes of this process. Despite the critical role of oxidative stress in diabetes, most clinical trials with available antioxidants and vitamins have either failed to show any long term benefits or have produced inconsistent results (10-11). There has been growing interest in establishing the possible roles of oral hypoglycemic agents including Metformin in reduction of oxidative stress. Metformin, the most common prescribed oral medication in type 2 diabetes, lowers HbA1c around 1.5%, rarely causes hypoglycemia (compared with insulin or sulfonylureas), has relatively few contraindications, its adverse effects are generally tolerable, does not cause weight gain, is cheap, and is highly acceptable among patients. Given the long term benefits observed with metformin use, a role in modulating oxidative stress is imputable. We designed this study to evaluate the actions of metformin on oxidative stress in a group of 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
40 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

  • No history of serious chronic illnesses of heart, lung, and kidney
  • No prior treatment with anti-diabetes medications for either diabetes or conditions associated with hyperglycemia
  • No intake of prescribed or over-the-counter vitamins C and E in the past year; - No intake of aspirin in the past year
  • No history of excessive alcohol intake in the past year

研究组 & 干预措施

Case

Active Comparator

Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification

干预措施: Metformin (Drug)

结局指标

主要结局

Serum concentrations of various markers of oxidative stress

时间窗: 12 weeks

Serum concentrations of markers of oxidative stress (i.e. advanced glycation end products, advanced oxidation protein products, ferritin reducing ability of plasma) along with activities of antioxidant enzymes (i.e. paraoxonase1, lecithin cholesterol asyltransferase) are measured. To assess the change in inflammatory condition associated with fat tissue dysfunction (a close entity to oxidative stress) serum concentrations of fat tissue hormones (i.e. leptin, vaspin, adiponectin, visfatin)are also assessed.

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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