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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03343262
Enrollment
158
Registered
2017-11-17
Start date
2018-01-01
Completion date
2020-12-31
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Glucose Tolerance

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.

Interventions

DEVICEta-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.

OTHERElectro-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.

Sponsors

China Academy of Chinese Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FPGBaseline and 6 week, 12 weeksThe fasting plasma glucose (FPG) is used to diagnose diabetes. IGT can be diagnosed base on FPG less than 7.0 mmol/L.
OGGTBaseline and 6 week, 12 weeksThe 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

MeasureTime frameDescription
BMIBaseline and 12 weeksThe body mass index are used to diagnose Obesity. Weight and height will be combined to report BMI in kg/m\^2
A1CBaseline and 6 week,baseline and 12 weeksThe hemoglobin A1C (A1C) is a diagnostic test for diabetes. Diabetes can be diagnosed base on A1C more than 6.5%.

Other

MeasureTime frameDescription
pulseBaseline and 12 weeksNormal pulse should be more than 60 per minute, or less than 100 per minute.
respirationBaseline and 12 weeksNormal respiration should be more than 16 times, or less than 20 times.
blood pressureBaseline and 12 weeksThe systolic pressure should be no more than 139 mmHG, and the diastolic pressure should be no less than 89 mmHg.
body temperatureBaseline and 12 weeksNormal temperature should be more than 36 C, or less than 37 C.

Contacts

Primary ContactPeijing Rong, doctor
drrongpj@163.com0086 01064089302

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026