Diabetes Mellitus, Type 2NCT00379379
Study of Improving Insulin Sensitivity by Electroacupuncture Therapy
A study testing electroacupuncture in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to find out whether the hypoglycemic and improving insulin resistance effect will appear or not, when EA applying on specific acupoints of NIDDM patients. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance
- What is being tested?
- electroacupuncture
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2005to Dec 2005
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed NIDDM patient within 5 years
- age between 30 to 65 years old
- controlled BP below 140/90 mmHg
- oral hypoglycemic agent (OHA) therapy with Gliclazide twice per day.
Who cannot join
- disorders of hemostasis
- patient had received insulin therapy
- severe disease such as CVA, CAD within 6 months
- Arrhythmia history and on pacemaker.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Graduate Insititude of Integration Chinese And Western Medicine, China Medical University
Taichung, 40402
About this study
Official title: Study of Improving Insulin Sensitivity by Combined Both Electroacupuncture and Drug Therapy
The aim of this study is to find out whether the hypoglycemic and improving insulin resistance effect will appear or not, when EA applying on specific acupoints of NIDDM patients.
Read the detailed description
Some previous animal model studies reveal that electroacupuncture (EA) applying on specific acupoints, such as Zhongwan and Zusanli acupoint, can reduce plasma glucose levels and encourage insulin secretion, even improve insulin resistance. In this study, we want to observe these results on type II diabetic patients who have been diagnosed in five years under a study design of randomized control trial (RCT) to obtain evidence on clinical.
We undertook a randomized, single blind and sham group controlled study to evaluate the effect of EA with a frequency in 15 Hz and fixed intensity (10 mA) on human Zusanli acupoint. A total of 26 newly diagnostic type II diabetic patients are enrolled in this study. They are randomly divided into 2 groups. There are 13 patients in the experimental group (EG) with EA treatment, and the other 13 patients are divided into control group (CG) with sham treatment. The main outcome is the changes of laboratory parameters between before and 30 minutes after the test.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Being tested
- electroacupuncture
- Keywords
- electroacupuncture, plasma glucose, plasma insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemic activity, plasma insulin level, HOMA index
Secondary outcomes (1)
Triglyceride, cholesterol, free fatty acid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startJan 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Enrolment
- 26 participants
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China
- Investigators
- Shih-Liang Chang, M.D., Ph.D., Principal investigator, Graduate Institude of Integration Chinese and Western Medicine, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379379
- Sponsor's protocol ID
- DMR93-IRB-127
- Status last verified
- Sep 2006
- First submitted
- 20 Sep 2006
- Last updated
- 21 Sep 2006
- Results posted
- No
Publications
Chang SL, Lin JG, Chi TC, Liu IM, Cheng JT. An insulin-dependent hypoglycaemia induced by electroacupuncture at the Zhongwan (CV12) acupoint in diabetic rats. Diabetologia. 1999 Feb;42(2):250-5. doi: 10.1007/s001250051146.
PubMed 10064107Lin JG, Chang SL, Cheng JT. Release of beta-endorphin from adrenal gland to lower plasma glucose by the electroacupuncture at Zhongwan acupoint in rats. Neurosci Lett. 2002 Jun 21;326(1):17-20. doi: 10.1016/s0304-3940(02)00331-2.
PubMed 12052528Lin JG, Chen WC, Hsieh CL, Tsai CC, Cheng YW, Cheng JT, Chang SL. Multiple sources of endogenous opioid peptide involved in the hypoglycemic response to 15 Hz electroacupuncture at the Zhongwan acupoint in rats. Neurosci Lett. 2004 Aug 5;366(1):39-42. doi: 10.1016/j.neulet.2004.05.003.
PubMed 15265586Chang SL, Tsai CC, Lin JG, Hsieh CL, Lin RT, Cheng JT. Involvement of serotonin in the hypoglycemic response to 2 Hz electroacupuncture of zusanli acupoint (ST36) in rats. Neurosci Lett. 2005 Apr 29;379(1):69-73. doi: 10.1016/j.neulet.2004.12.057. Epub 2005 Jan 20.
PubMed 15814202Chang SL, Lin KJ, Lin RT, Hung PH, Lin JG, Cheng JT. Enhanced insulin sensitivity using electroacupuncture on bilateral Zusanli acupoints (ST 36) in rats. Life Sci. 2006 Aug 1;79(10):967-71. doi: 10.1016/j.lfs.2006.05.005. Epub 2006 May 17.
PubMed 16762373
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Improving Insulin Sensitivity by Combined Both Electroacupuncture and Drug Therapy
- ClinicalTrials.gov ID
- NCT00379379
- Acronym / sponsor ID
- DMR93-IRB-127
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Keywords
- electroacupuncture, plasma glucose, plasma insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, China
- Study start
- Jan 2005
- Study completion
- Dec 2005
- First posted
- 21 Sep 2006 (estimated)
- 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.
The aim of this study is to find out whether the hypoglycemic and improving insulin resistance effect will appear or not, when EA applying on specific acupoints of NIDDM patients.
Detailed description
Some previous animal model studies reveal that electroacupuncture (EA) applying on specific acupoints, such as Zhongwan and Zusanli acupoint, can reduce plasma glucose levels and encourage insulin secretion, even improve insulin resistance. In this study, we want to observe these results on type II diabetic patients who have been diagnosed in five years under a study design of randomized control trial (RCT) to obtain evidence on clinical.
We undertook a randomized, single blind and sham group controlled study to evaluate the effect of EA with a frequency in 15 Hz and fixed intensity (10 mA) on human Zusanli acupoint. A total of 26 newly diagnostic type II diabetic patients are enrolled in this study. They are randomly divided into 2 groups. There are 13 patients in the experimental group (EG) with EA treatment, and the other 13 patients are divided into control group (CG) with sham treatment. The main outcome is the changes of laboratory parameters between before and 30 minutes after the test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- newly diagnosed NIDDM patient within 5 years
- age between 30 to 65 years old
- controlled BP below 140/90 mmHg
- oral hypoglycemic agent (OHA) therapy with Gliclazide twice per day.
Key exclusion criteria (4 listed)
- disorders of hemostasis
- patient had received insulin therapy
- severe disease such as CVA, CAD within 6 months
- Arrhythmia history and on pacemaker.
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 |
|---|---|---|
| electroacupuncture | Device | – |
Primary outcome
Hypoglycemic activity, plasma insulin level, HOMA index
1 secondary outcome
Triglyceride, cholesterol, free fatty acid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2006.
- Background: PubMed 10064107Chang SL, Lin JG, Chi TC, Liu IM, Cheng JT. An insulin-dependent hypoglycaemia induced by electroacupuncture at the Zhongwan (CV12) acupoint in diabetic rats. Diabetologia. 1999 Feb;42(2):250-5. doi: 10.1007/s001250051146.
- Background: PubMed 12052528Lin JG, Chang SL, Cheng JT. Release of beta-endorphin from adrenal gland to lower plasma glucose by the electroacupuncture at Zhongwan acupoint in rats. Neurosci Lett. 2002 Jun 21;326(1):17-20. doi: 10.1016/s0304-3940(02)00331-2.
- Background: PubMed 15265586Lin JG, Chen WC, Hsieh CL, Tsai CC, Cheng YW, Cheng JT, Chang SL. Multiple sources of endogenous opioid peptide involved in the hypoglycemic response to 15 Hz electroacupuncture at the Zhongwan acupoint in rats. Neurosci Lett. 2004 Aug 5;366(1):39-42. doi: 10.1016/j.neulet.2004.05.003.
- Background: PubMed 15814202Chang SL, Tsai CC, Lin JG, Hsieh CL, Lin RT, Cheng JT. Involvement of serotonin in the hypoglycemic response to 2 Hz electroacupuncture of zusanli acupoint (ST36) in rats. Neurosci Lett. 2005 Apr 29;379(1):69-73. doi: 10.1016/j.neulet.2004.12.057. Epub 2005 Jan 20.
- Background: PubMed 16762373Chang SL, Lin KJ, Lin RT, Hung PH, Lin JG, Cheng JT. Enhanced insulin sensitivity using electroacupuncture on bilateral Zusanli acupoints (ST 36) in rats. Life Sci. 2006 Aug 1;79(10):967-71. doi: 10.1016/j.lfs.2006.05.005. Epub 2006 May 17.
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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.
Shih-Liang Chang, M.D., Ph.D. principal investigator
Graduate Institude of Integration Chinese and Western Medicine, China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by China Medical University Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 21 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemic activity, plasma insulin level, HOMA index. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379379, which also lists 5 linked publications.
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 21 Sep 2006.