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

NCT ID: NCT03343262

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ta-VNS "yidan-pi"

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

Group Type EXPERIMENTAL

ta-VNS

Intervention Type DEVICE

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-acupuncture

Intervention Type OTHER

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.

ta-VNS "jian"

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

Group Type PLACEBO_COMPARATOR

Electro-acupuncture

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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transcutaneous vagus nerve stimulation

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Peijing Rong

The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peijing Rong, doctor

Role: STUDY_DIRECTOR

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Central Contacts

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Peijing Rong, doctor

Role: CONTACT

Phone: 0086 01064089302

Email: [email protected]

Other Identifiers

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ChinaACMS-4

Identifier Type: -

Identifier Source: org_study_id