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

Study Overview
=================
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.

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

Conditions
-----------------
Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Device: ta-VNS
* Other: Electro-acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ta-VNS yidan-pi<br>Device:ta-VNS & Electro-acupuncture(yidan-pi auricular acupoints):2 times per day,2 days per week for 12 weeks | Device: ta-VNS<br>* The transcutaneous vagus nerve stimulation (taVNS) at auricular concha is a typical representative of TCM modernization. The taVNS regulates the autonomic nervous system, which shows a good therapeutic effect for the treatment of IGT.<br>* Other names: transcutaneous vagus nerve stimulation;Other: Electro-acupuncture<br>* one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.<br>|
| Placebo Comparator: ta-VNS jian<br>Device:ta-VNS & Electro-acupuncture(jian auricular acupoints):2 times per day,2 days per week for 12 weeks | Other: Electro-acupuncture<br>* one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG | The fasting plasma glucose (FPG) is used to diagnose diabetes. IGT can be diagnosed base on FPG less than 7.0 mmol/L. | Baseline and 6 week, 12 weeks | 
| OGGT | 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. | Baseline and 6 week, 12 weeks | 

Secondary Outcome Measures

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