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

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 Overview

• Status: Unknown
• Conditions: Impaired Glucose Tolerance
• Intervention / Treatment: Other: Electro-acupuncture; Device: ta-VNS

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peijing Rong, doctor; Phone Number: 0086 01064089302; Email: drrongpj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ta-VNS "yidan-pi"; Device:ta-VNS & Electro-acupuncture("yidan-pi" auricular acupoints):2 times per day,2 days per week for 12 weeks	Other: Electro-acupuncture; 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.; Device: ta-VNS; 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.; Other Names: transcutaneous vagus nerve stimulation
Placebo Comparator: ta-VNS "jian"; Device:ta-VNS & Electro-acupuncture("jian" auricular acupoints):2 times per day,2 days per week for 12 weeks	Other: Electro-acupuncture; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulse	Normal pulse should be more than 60 per minute, or less than 100 per minute.	Baseline and 12 weeks
respiration	Normal respiration should be more than 16 times, or less than 20 times.	Baseline and 12 weeks
blood pressure	The systolic pressure should be no more than 139 mmHG, and the diastolic pressure should be no less than 89 mmHg.	Baseline and 12 weeks
body temperature	Normal temperature should be more than 36 C, or less than 37 C.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Investigators: Study Director: Peijing Rong, doctor, Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: ChinaACMS-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No