Impaired Glucose ToleranceNCT03343262
Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
A study testing ta-VNS and Electro-acupuncture in people with Impaired Glucose Tolerance, run by China Academy of Chinese Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- ta-VNS and Electro-acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- ta-VNS, Electro-acupuncture
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ta-VNSDevice
Also called transcutaneous vagus nerve stimulation
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.
Electro-acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ta-VNS "yidan-pi" | Experimental | Device:ta-VNS \& Electro-acupuncture("yidan-pi" auricular acupoints):2 times per day,2 days per week for 12 weeks Receives: Device: ta-VNS; Other: Electro-acupuncture |
| ta-VNS "jian" | Placebo comparator | Device:ta-VNS \& Electro-acupuncture("jian" auricular acupoints):2 times per day,2 days per week for 12 weeks Receives: Other: Electro-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
FPG
The fasting plasma glucose (FPG) is used to diagnose diabetes. IGT can be diagnosed base on FPG less than 7.0 mmol/L.
Measured: Baseline and 6 week, 12 weeks
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.
Measured: Baseline and 6 week, 12 weeks
Secondary outcomes (2)
BMI
The body mass index are used to diagnose Obesity. Weight and height will be combined to report BMI in kg/m^2
Measured: Baseline and 12 weeks
A1C
The hemoglobin A1C (A1C) is a diagnostic test for diabetes. Diabetes can be diagnosed base on A1C more than 6.5%.
Measured: Baseline and 6 week,baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peijing Rong, China Academy of Chinese Medical Sciences
- Investigators
- Peijing Rong, doctor, Study director, Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343262
- Sponsor's protocol ID
- ChinaACMS-4
- Status last verified
- Nov 2017
- First submitted
- 30 Oct 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
- ClinicalTrials.gov ID
- NCT03343262
- Acronym / sponsor ID
- ChinaACMS-4
- Conditions
- Impaired Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ta-VNS "yidan-pi" | Experimental | Device: ta-VNS, Other: Electro-acupunctureDevice:ta-VNS \& Electro-acupuncture("yidan-pi" auricular acupoints):2 times per day,2 days per week for 12 weeks |
| ta-VNS "jian" | Placebo comparator | Other: Electro-acupunctureDevice:ta-VNS \& Electro-acupuncture("jian" auricular acupoints):2 times per day,2 days per week for 12 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ta-VNSAlso: transcutaneous vagus nerve stimulationThe 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. | Device | ta-VNS "yidan-pi" |
| Electro-acupunctureone 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. | Other | ta-VNS "jian", ta-VNS "yidan-pi" |
Primary outcome
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.
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.
2 secondary outcomes
BMI
Time frame: Baseline and 12 weeks
A1C
Time frame: Baseline and 6 week,baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peijing Rong, doctor study director
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing ta-VNS and Electro-acupuncture in people with Impaired Glucose Tolerance, run by China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peijing Rong, doctor (0086 01064089302, drrongpj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FPG (time frame: Baseline and 6 week, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.