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

Not Applicable

• Conditions: Impaired Glucose Tolerance
• Interventions: Device: ta-VNS; Other: Electro-acupuncture

• Registration Number: NCT03343262
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-30
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-17
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-22
• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ta-VNS "yidan-pi"	ta-VNS	Device:ta-VNS \& Electro-acupuncture("yidan-pi" auricular acupoints):2 times per day,2 days per week for 12 weeks
ta-VNS "yidan-pi"	Electro-acupuncture	Device:ta-VNS \& Electro-acupuncture("yidan-pi" auricular acupoints):2 times per day,2 days per week for 12 weeks
ta-VNS "jian"	Electro-acupuncture	Device:ta-VNS \& Electro-acupuncture("jian" auricular acupoints):2 times per day,2 days per week for 12 weeks

Primary Outcome Measures

Name	Time	Method
FPG	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	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.

Secondary Outcome Measures

Name	Time	Method
A1C	Baseline and 6 week,baseline and 12 weeks	The hemoglobin A1C (A1C) is a diagnostic test for diabetes. Diabetes can be diagnosed base on A1C more than 6.5%.
BMI	Baseline and 12 weeks	The body mass index are used to diagnose Obesity. Weight and height will be combined to report BMI in kg/m\^2