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

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ClinicalTrials.gov Identifier: NCT03343262
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Impaired Glucose Tolerance Device: ta-VNS Other: Electro-acupuncture

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
Anticipated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arms and Interventions

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
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 Name: transcutaneous vagus nerve stimulation
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.
Placebo Comparator: ta-VNS "jian"
Device:ta-VNS & Electro-acupuncture("jian" auricular acupoints):2 times per day,2 days per week for 12 weeks
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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%.


Other Outcome Measures:
  1. pulse [ Time Frame: Baseline and 12 weeks ]
    Normal pulse should be more than 60 per minute, or less than 100 per minute.

  2. respiration [ Time Frame: Baseline and 12 weeks ]
    Normal respiration should be more than 16 times, or less than 20 times.

  3. 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.

  4. body temperature [ Time Frame: Baseline and 12 weeks ]
    Normal temperature should be more than 36 C, or less than 37 C.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343262


Contacts
Contact: Peijing Rong, doctor 0086 01064089302 drrongpj@163.com

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
Study Director: Peijing Rong, doctor Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
More Information

Responsible Party: Peijing Rong, The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03343262     History of Changes
Other Study ID Numbers: ChinaACMS-4
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases