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临床试验/NCT03343262
NCT03343262Unknown不适用

Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture

China Academy of Chinese Medical Sciences0 个研究点目标入组 158 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
158
主要终点
FPG

研究概览

简要总结

Impaired Glucose Tolerance (IGT) is an abnormal metabolic state following glucose metabolic steady state but prior to diabetes. IGT is an important stage during the progression of diabetes, with an underlying mechanism of insulin resistance and pancreatic β cell dysfunction. IGT is one of the diseases that shows significant beneficial response to acupuncture treatment. Original findings from the investigators'laboratory show that transcutaneous auricular vagus nerve stimulation (taVNS) which is innervated by vagus nerve, would enhance the activity of pancreatic β cells, promote the secretion of insulin, upregulate the expression of insulin receptors in central as well as peripheral tissues, thus to improve glycometabolism. In this study, the investigators would further illuminate the mechanism of taVNS at "yidan-pi" auricular acupoints on the regulation of glucose metabolism, its improvement of the IGT state in rat model, as well as its regulation effect on insulin receptor expression and insulin resistance, and systematically illustrate the clinical effective of this treatment on IGT, with emphasize on its influence on the concentrations of glucose and HbA1c, and thus provide an effective proposal for clinical acupuncture.

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ages between 20 and 70
  • fasting plasma-glucose(FPG) less than 7 mmol/L, or 2h p-glucose 7.8-11.1 mmol/L
  • anti-diabetic medication of any kind
  • able to provide informed consent

排除标准

  • comorbidities that would prohibit participation in study procedures, including cardiovascular disease, hematological system disease or psychosis
  • females of childbearing potential who were pregnant, breast-feeding
  • infection within the 1 month
  • known or suspected abuse of alcohol or narcotics

结局指标

主要结局

FPG

时间窗: Baseline and 6 week, 12 weeks

The fasting plasma glucose (FPG) is used to diagnose diabetes. IGT can be diagnosed base on FPG less than 7.0 mmol/L.

OGGT

时间窗: Baseline and 6 week, 12 weeks

The 2-hour plasma glucose after a 75-g oral glucose tolerance test (OGTT) is used to diagnose diabetes. IGT can be diagnosed base on 2-hour plasma Glucose between 7.8 and 11.1 mmol/L.

次要结局

  • A1C(Baseline and 6 week,baseline and 12 weeks)
  • BMI(Baseline and 12 weeks)

研究者

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

Peijing Rong

The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

China Academy of Chinese Medical Sciences

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