- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03343262
Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
November 21, 2017 updated by: Peijing Rong, China Academy of Chinese Medical Sciences
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
158
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peijing Rong, doctor
- Phone Number: 0086 01064089302
- Email: drrongpj@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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
|
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.
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:
|
Placebo Comparator: ta-VNS "jian"
Device:ta-VNS & Electro-acupuncture("jian" auricular acupoints):2 times per day,2 days per week for 12 weeks
|
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
Time Frame: Baseline and 6 week, 12 weeks
|
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
Time Frame: Baseline and 6 week, 12 weeks
|
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
Time Frame: Baseline and 12 weeks
|
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
Time Frame: Baseline and 6 week,baseline and 12 weeks
|
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
Time Frame: Baseline and 12 weeks
|
Normal pulse should be more than 60 per minute, or less than 100 per minute.
|
Baseline and 12 weeks
|
respiration
Time Frame: Baseline and 12 weeks
|
Normal respiration should be more than 16 times, or less than 20 times.
|
Baseline and 12 weeks
|
blood pressure
Time Frame: Baseline and 12 weeks
|
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
Time Frame: Baseline and 12 weeks
|
Normal temperature should be more than 36 C, or less than 37 C.
|
Baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Peijing Rong, doctor, Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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