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

China Academy of Chinese Medical Sciences158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

158

Conditions

Impaired Glucose Tolerance

ta-VNSDEVICE

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.

Electro-acupunctureOTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

FPG

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

Time frame: 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.

Time frame: Baseline and 6 week, 12 weeks

Secondary Outcomes

BMI

The body mass index are used to diagnose Obesity. Weight and height will be combined to report BMI in kg/m\^2

Time frame: 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%.

Time frame: Baseline and 6 week,baseline and 12 weeks