Physiological Effect of TCC on Glucose MetabolismNCT03503084
Short-term Effects of Tai Chi Chuan Exercise on the Regulation of Lipid and Glucose Metabolisms and Endothelial Function
A study testing Classical Yang's TCC exercise in people with Physiological Effect of TCC on Glucose Metabolism, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
The short term effects of TCC exercise are the significant increase in serum insulin and insulin resistance, and the significant decrease in serum TC, HDL-C, ET-1 and insulin sensitivity in TCC practitioners. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physiological Effect of TCC on Glucose Metabolism
- What is being tested?
- Classical Yang's TCC exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2009to 31 Dec 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- TCC practitioners in a TCC training center in Taiwan over 50 years of age
- Healthy subjects without TCC experience over 50 years of age
Who cannot join
- Subjects who had major cardiopulmonary disease
- Subjects who have diabetes mellitus, renal or liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Tai Chi Chuan on the Endothelin, Insulin, Blood Lipid, Blood Sugar, Aldosterone and Hemodynamics in the Elderly Adults
The short term effects of TCC exercise are the significant increase in serum insulin and insulin resistance, and the significant decrease in serum TC, HDL-C, ET-1 and insulin sensitivity in TCC practitioners. TCC might be benefit the health of its practitioners through the regulation of lipid and glucose metabolism and endothelial function.
Read the detailed description
Tai Chi Chuan (TCC) has been shown to be beneficial to the health. However, its effects on lipid and glucose metabolism are not fully understood. This study investigated the short term effect of TCC exercise on lipid and glucose metabolism and endothelial function in TCC practitioners. Twenty-one TCC practitioners and nineteen normal controls were included in this study. The hemodynamics, serum insulin, indices of insulin resistance/sensitivity, serum endothelin-1 (ET-1), blood lipids and aldosterone before and 30 min after a rest or a session of classical Yang's TCC exercise were compared.
- Being tested
- Classical Yang's TCC exercise
- Keywords
- Tai Chi Chuan, insulin resistance, cholesterol, endothelin-1
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical Yang's TCC exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| TCC group | Experimental | Classical Yang's TCC exercise Receives: Behavioral: Classical Yang's TCC exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in quantitative insulin sensitivity check index
change in insulin sensitivity due to TCC
Measured: before and 30 minutes after the completion of TCC exercise
Secondary outcomes (2)
change in serum total cholesterol
change in serum total cholesterol due to TCC
Measured: before and 30 minutes after the completion of TCC exercise
change in homeostasis model assessment-estimated insulin resistance
change in insulin resistance by TCC
Measured: before and 30 minutes after the completion of TCC exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 May 2009
- Primary completion30 Nov 2009
- Study completion31 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Physiological Effect of TCC on Glucose MetabolismStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Twenty-one TCC practitioners and nineteen normal controls were included in this study. The hemodynamics, serum insulin, indices of insulin resistance/sensitivity, serum endothelin-1 (ET-1), blood lipids and aldosterone before and 30 min after a rest or a session of classical Yang's TCC exercise were compared.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Principal investigator, Cheng-Deng Kuo, Changhua Christian Hospital
- Investigators
- Cheng-Deng Kuo, MD,PhD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503084
- Sponsor's protocol ID
- V98E2-014
- Status last verified
- Apr 2018
- First submitted
- 30 Mar 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are available after the manuscript has been accepted for publication
Publications
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
PubMed 3899825Muniyappa R, Lee S, Chen H, Quon MJ. Current approaches for assessing insulin sensitivity and resistance in vivo: advantages, limitations, and appropriate usage. Am J Physiol Endocrinol Metab. 2008 Jan;294(1):E15-26. doi: 10.1152/ajpendo.00645.2007. Epub 2007 Oct 23.
PubMed 17957034Couillard C, Despres JP, Lamarche B, Bergeron J, Gagnon J, Leon AS, Rao DC, Skinner JS, Wilmore JH, Bouchard C. Effects of endurance exercise training on plasma HDL cholesterol levels depend on levels of triglycerides: evidence from men of the Health, Risk Factors, Exercise Training and Genetics (HERITAGE) Family Study. Arterioscler Thromb Vasc Biol. 2001 Jul;21(7):1226-32. doi: 10.1161/hq0701.092137.
PubMed 11451756Lu WA, Kuo CD. The effect of Tai Chi Chuan on the autonomic nervous modulation in older persons. Med Sci Sports Exerc. 2003 Dec;35(12):1972-6. doi: 10.1249/01.MSS.0000099242.10669.F7.
PubMed 14652490Lu WA, Kuo CD. Three months of Tai Chi Chuan exercise can reduce serum triglyceride and endothelin-1 in the elderly. Complement Ther Clin Pract. 2013 Nov;19(4):204-8. doi: 10.1016/j.ctcp.2013.06.007. Epub 2013 Jul 27.
PubMed 24199974Salgado AL, Carvalho Ld, Oliveira AC, Santos VN, Vieira JG, Parise ER. Insulin resistance index (HOMA-IR) in the differentiation of patients with non-alcoholic fatty liver disease and healthy individuals. Arq Gastroenterol. 2010 Apr-Jun;47(2):165-9. doi: 10.1590/s0004-28032010000200009.
PubMed 20721461Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab. 2000 Jul;85(7):2402-10. doi: 10.1210/jcem.85.7.6661.
PubMed 10902785
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tai Chi Chuan on the Endothelin, Insulin, Blood Lipid, Blood Sugar, Aldosterone and Hemodynamics in the Elderly Adults
- ClinicalTrials.gov ID
- NCT03503084
- Acronym / sponsor ID
- V98E2-014
- Keywords
- Tai Chi Chuan, insulin resistance, cholesterol, endothelin-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 1 May 2009 (actual)
- Primary completion
- 30 Nov 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 19 Apr 2018 (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.
The short term effects of TCC exercise are the significant increase in serum insulin and insulin resistance, and the significant decrease in serum TC, HDL-C, ET-1 and insulin sensitivity in TCC practitioners. TCC might be benefit the health of its practitioners through the regulation of lipid and glucose metabolism and endothelial function.
Detailed description
Tai Chi Chuan (TCC) has been shown to be beneficial to the health. However, its effects on lipid and glucose metabolism are not fully understood. This study investigated the short term effect of TCC exercise on lipid and glucose metabolism and endothelial function in TCC practitioners. Twenty-one TCC practitioners and nineteen normal controls were included in this study. The hemodynamics, serum insulin, indices of insulin resistance/sensitivity, serum endothelin-1 (ET-1), blood lipids and aldosterone before and 30 min after a rest or a session of classical Yang's TCC exercise were compared.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Twenty-one TCC practitioners and nineteen normal controls were included in this study. The hemodynamics, serum insulin, indices of insulin resistance/sensitivity, serum endothelin-1 (ET-1), blood lipids and aldosterone before and 30 min after a rest or a session of classical Yang's TCC exercise were compared.
| Arm | Type | Receives |
|---|---|---|
| TCC group | Experimental | Behavioral: Classical Yang's TCC exerciseClassical Yang's TCC exercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- TCC practitioners in a TCC training center in Taiwan over 50 years of age
- Healthy subjects without TCC experience over 50 years of age
Key exclusion criteria (2 listed)
- Subjects who had major cardiopulmonary disease
- Subjects who have diabetes mellitus, renal or liver disease
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 |
|---|---|---|
| Classical Yang's TCC exercise | Behavioural | TCC group |
Primary outcome
change in quantitative insulin sensitivity check index
Time frame: before and 30 minutes after the completion of TCC exercise
change in insulin sensitivity due to TCC
2 secondary outcomes
change in serum total cholesterol
Time frame: before and 30 minutes after the completion of TCC exercise
change in homeostasis model assessment-estimated insulin resistance
Time frame: before and 30 minutes after the completion of TCC exercise
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 19 Apr 2018.
- Results publication: PubMed 3899825Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
- Results publication: PubMed 17957034Muniyappa R, Lee S, Chen H, Quon MJ. Current approaches for assessing insulin sensitivity and resistance in vivo: advantages, limitations, and appropriate usage. Am J Physiol Endocrinol Metab. 2008 Jan;294(1):E15-26. doi: 10.1152/ajpendo.00645.2007. Epub 2007 Oct 23.
- Results publication: PubMed 11451756Couillard C, Despres JP, Lamarche B, Bergeron J, Gagnon J, Leon AS, Rao DC, Skinner JS, Wilmore JH, Bouchard C. Effects of endurance exercise training on plasma HDL cholesterol levels depend on levels of triglycerides: evidence from men of the Health, Risk Factors, Exercise Training and Genetics (HERITAGE) Family Study. Arterioscler Thromb Vasc Biol. 2001 Jul;21(7):1226-32. doi: 10.1161/hq0701.092137.
- Results publication: PubMed 14652490Lu WA, Kuo CD. The effect of Tai Chi Chuan on the autonomic nervous modulation in older persons. Med Sci Sports Exerc. 2003 Dec;35(12):1972-6. doi: 10.1249/01.MSS.0000099242.10669.F7.
- Results publication: PubMed 24199974Lu WA, Kuo CD. Three months of Tai Chi Chuan exercise can reduce serum triglyceride and endothelin-1 in the elderly. Complement Ther Clin Pract. 2013 Nov;19(4):204-8. doi: 10.1016/j.ctcp.2013.06.007. Epub 2013 Jul 27.
- Results publication: PubMed 20721461Salgado AL, Carvalho Ld, Oliveira AC, Santos VN, Vieira JG, Parise ER. Insulin resistance index (HOMA-IR) in the differentiation of patients with non-alcoholic fatty liver disease and healthy individuals. Arq Gastroenterol. 2010 Apr-Jun;47(2):165-9. doi: 10.1590/s0004-28032010000200009.
- Results publication: PubMed 10902785Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab. 2000 Jul;85(7):2402-10. doi: 10.1210/jcem.85.7.6661.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are available after the manuscript has been accepted for publication
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.
Cheng-Deng Kuo, MD,PhD principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical Yang's TCC exercise in people with Physiological Effect of TCC on Glucose Metabolism, run by Changhua Christian 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 2 inclusion and 2 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 19 Apr 2018. 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?
change in quantitative insulin sensitivity check index (time frame: before and 30 minutes after the completion of TCC exercise). 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 NCT03503084, which also lists 7 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 19 Apr 2018.