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

Impaired Glucose Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03343262
• Other study ID #: ChinaACMS-4
• Status: Not yet recruiting
• Phase: N/A
• First received: October 30, 2017
• Last updated: November 21, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2017
• Source: China Academy of Chinese Medical Sciences
• Contact: Peijing Rong, doctor
• Phone: 0086 01064089302
• Email: drrongpj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pulse	Normal pulse should be more than 60 per minute, or less than 100 per minute.	Baseline and 12 weeks
Other	respiration	Normal respiration should be more than 16 times, or less than 20 times.	Baseline and 12 weeks
Other	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
Other	body temperature	Normal temperature should be more than 36 C, or less than 37 C.	Baseline and 12 weeks
Primary	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
Primary	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	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
Secondary	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