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临床试验/NCT02535299
NCT02535299Unknown4 期

The Correlation Between Par-4 and Telomere-telomerase System in the New Dignosised Type 2 Diabetes Patients Who Received GLP-1 Analog or Metformin Treatment

Third Military Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
200
试验地点
1
主要终点
physiological parameter:glycosylated hemoglobin A1c

研究概览

简要总结

Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about telomere-telomerase system and Par-4.

详细描述

160 Type 2 diabetes in our hospital will divide into 4 groups: group A (40 healthy volunteers), group B (40 patients who give basal and insulin treatment, group C(40 patients who give basal and Liraglutide treatment),group D(40 patients who give basal and metformin treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c(HbA1c),homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, telomere length,telomerase activity will record respectively. And High-sensitive C-reactive protein (HsCRP), Par-4, GST,SOD,GSH-PX,ATF-6,CHOP,XBP-1 and Tumor necrosis factor-α(TNF-α) will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly dignosised type 2 diabetes according to WHO criteria.glycated hemoglobin (HbA1c) was more than 10%;
  • Seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (GAD);

排除标准

  • Type 1 diabetes mellitus,presence of autoimmune diabetes indicated by antibodies to insulin, islet cells, and GAD;
  • Gestational diabetes;
  • patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease;

研究组 & 干预措施

insulin

Experimental

basic insulin treatment:glargine 10-30 units once a day based on the glucose control for 6 months.

干预措施: Liraglutide (Drug)

insulin

Experimental

basic insulin treatment:glargine 10-30 units once a day based on the glucose control for 6 months.

干预措施: Metformin (Drug)

结局指标

主要结局

physiological parameter:glycosylated hemoglobin A1c

时间窗: up to 6 months;

up to 6 months;;HbA1c was measured by a certified hospital laboratory according to established and approved protocols

次要结局

  • physiological parameter:the concentration of Par-4(up to 6 months;)
  • physiological parameter:telomease activity(up to 6 months;)
  • physiological parameter:TNF-α(up to 6 months;)
  • physiological parameter:telomere length(up to 6 months;)

研究者

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

Wu Qinan

the Third Military Medical University

Third Military Medical University

研究点 (1)

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