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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
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 30, 2017
    Last Updated
    November 21, 2017
    Sponsor
    China Academy of Chinese Medical Sciences
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    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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