Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
Primary Purpose
Impaired Glucose Tolerance
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ta-VNS
Electro-acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Glucose Tolerance
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ta-VNS "yidan-pi"
ta-VNS "jian"
Arm Description
Device:ta-VNS & Electro-acupuncture("yidan-pi" auricular acupoints):2 times per day,2 days per week for 12 weeks
Device:ta-VNS & Electro-acupuncture("jian" auricular acupoints):2 times per day,2 days per week for 12 weeks
Outcomes
Primary Outcome Measures
FPG
The fasting plasma glucose (FPG) is used to diagnose diabetes. IGT can be diagnosed base on FPG less than 7.0 mmol/L.
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.
Secondary Outcome Measures
BMI
The body mass index are used to diagnose Obesity. Weight and height will be combined to report BMI in kg/m^2
A1C
The hemoglobin A1C (A1C) is a diagnostic test for diabetes. Diabetes can be diagnosed base on A1C more than 6.5%.
Full Information
NCT ID
NCT03343262
First Posted
October 30, 2017
Last Updated
November 21, 2017
Sponsor
China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03343262
Brief Title
Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
Official Title
Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ta-VNS "yidan-pi"
Arm Type
Experimental
Arm Description
Device:ta-VNS & Electro-acupuncture("yidan-pi" auricular acupoints):2 times per day,2 days per week for 12 weeks
Arm Title
ta-VNS "jian"
Arm Type
Placebo Comparator
Arm Description
Device:ta-VNS & Electro-acupuncture("jian" auricular acupoints):2 times per day,2 days per week for 12 weeks
Intervention Type
Device
Intervention Name(s)
ta-VNS
Other Intervention Name(s)
transcutaneous vagus nerve stimulation
Intervention Description
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
Other
Intervention Name(s)
Electro-acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
FPG
Description
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
Title
OGGT
Description
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 Outcome Measure Information:
Title
BMI
Description
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
Title
A1C
Description
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
Other Pre-specified Outcome Measures:
Title
pulse
Description
Normal pulse should be more than 60 per minute, or less than 100 per minute.
Time Frame
Baseline and 12 weeks
Title
respiration
Description
Normal respiration should be more than 16 times, or less than 20 times.
Time Frame
Baseline and 12 weeks
Title
blood pressure
Description
The systolic pressure should be no more than 139 mmHG, and the diastolic pressure should be no less than 89 mmHg.
Time Frame
Baseline and 12 weeks
Title
body temperature
Description
Normal temperature should be more than 36 C, or less than 37 C.
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peijing Rong, doctor
Phone
0086 01064089302
Email
drrongpj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peijing Rong, doctor
Organizational Affiliation
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
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