Type 2 Diabetes MellitusNCT03562078
Tai Chi Quan Improving Biochemistry and Quality of Life in Type 2 Diabetes
A study testing Tai Chi Quan in people with Type 2 Diabetes Mellitus, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry profile, and also better quality of life and activity of autonomic nerve system (ANS). The subjects were randomize assigned to either Tai Chi group or control group. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Tai Chi Quan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 May 2017to Sep 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40~80 years old
- Diagnosed type 2 diabetes mellitus, and without changing dietary pattern and medical treatment for blood glucose or blood lipid.
- Consciousness clear and is voluntary to attend the project and with the agreement.
- The functional movement ability is independent
Who cannot join
- Pregnant or plan to be pregnant in six months, and breast feeding.
- Severe complication in six months such as myocardial infarction, stroke, severe traumatic injury, major surgery. Other diseases evaluated by the doctor that are not suitable for the project.
- Evaluated that the compliance for the intervention is not appropriate.
- The blood glucose > 300mg/dl and unable to do vigorous exercise.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital
Taipei, 104
Chien-Jung Huang, Bachelor
About this study
Official title: Tai Chi Quan Improving Blood Glucose, Blood Lipid, and Quality of Life in Patients With Type 2 Diabetes
In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry profile, and also better quality of life and activity of autonomic nerve system (ANS). The subjects were randomize assigned to either Tai Chi group or control group. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose(FBG), triglycerides (TG), high and low density lipoprotein (HDL, LDL), creatinine(Cr), eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.
Read the detailed description
In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry index, and also better quality of life and activity of automatic nerve system. In the study, type 2 diabetes mellitus(T2DM) patients will be recruited as subjects. The subjects were randomized to either Tai Chi group or control group. Tai Chi group would take Tai Chi Quan training for 1hr, twice a week for 12 weeks. There were 10-minute warm-up, 40-minute Tai Chi lesson, and 10-minute cool-down exercise in the training. In this study, the 1st section of Yang style 108 form is chosen for the experiment group. Both group were given diabetic patients care education and the exercise recording book for encouraging the daily exercise habits. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose, triglycerides, high and low density lipid, creatinine, eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Tai Chi Quan
- Keywords
- Tai Chi Quan, HbA1c, quality of life
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi QuanBehavioural
the first section of Yang style 108 form, including 10-minute warm-up, 40-minute training, and 10-minute cool-down exercise, twice a week
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Quan for Type 2 Diabetes | Experimental | diabetic patients care education and Tai Chi Quan training, including 10-minute warm-up, 40-minute Tai Chi lesson, and 10-minute cool-down exercise in the training, twice a week for 12 weeks. Receives: Behavioral: Tai Chi Quan |
| Control Group for Type 2 Diabetes | No intervention | diabetic patients care education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
HbA1c
Measured: change from Baseline to 12 weeks
Secondary outcomes (11)
fasting blood glucose
blood sample after 8-hour fasting
Measured: change from Baseline to 12 weeks
triglycerides
blood sample after 8-hour fasting
Measured: change from Baseline to 12 weeks
high and low density lipoprotein
blood sample after 8-hour fasting
Measured: change from Baseline to 12 weeks
creatinine
blood sample after 8-hour fasting
Measured: change from Baseline to 12 weeks
estimated Glomerular Filtration Rate (eGFR)
blood sample after 8-hour fasting
Measured: change from Baseline to 12 weeks
Glutamic-Pyruvic Transaminase (GPT)
blood sample after 8-hour fasting
Measured: change from Baseline to 12 weeks
urine albumin/creatinine ratio (ACR)
from urine sample
Measured: change from Baseline to 12 weeks
quality of life
WHOQOL-BREF Taiwan
Measured: change from Baseline to 12 weeks
heart rate variability
represent for balance of autonomic nervous system
Measured: change from Baseline to 12 weeks
low frequency (LF)
Low frequency is the frequency domain analysis from heart rate variability, and is represent for sympathetic nervous system
Measured: change from Baseline to 12 weeks
high frequency (HF)
High frequency is the frequency domain analysis from heart rate variability, and is represent for parasympathetic nervous system
Measured: change from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start22 May 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Sponsor
- Investigators
- Chien-Jung Huang, Bachelor, Study chair, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562078
- Sponsor's protocol ID
- TaipeiCityH
- Status last verified
- Jun 2018
- First submitted
- 18 Apr 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Quan Improving Blood Glucose, Blood Lipid, and Quality of Life in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03562078
- Acronym / sponsor ID
- TaipeiCityH
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Tai Chi Quan, HbA1c, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- 22 May 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Jun 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.
In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry profile, and also better quality of life and activity of autonomic nerve system (ANS). The subjects were randomize assigned to either Tai Chi group or control group. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose(FBG), triglycerides (TG), high and low density lipoprotein (HDL, LDL), creatinine(Cr), eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.
Detailed description
In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry index, and also better quality of life and activity of automatic nerve system. In the study, type 2 diabetes mellitus(T2DM) patients will be recruited as subjects. The subjects were randomized to either Tai Chi group or control group. Tai Chi group would take Tai Chi Quan training for 1hr, twice a week for 12 weeks. There were 10-minute warm-up, 40-minute Tai Chi lesson, and 10-minute cool-down exercise in the training. In this study, the 1st section of Yang style 108 form is chosen for the experiment group. Both group were given diabetic patients care education and the exercise recording book for encouraging the daily exercise habits. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose, triglycerides, high and low density lipid, creatinine, eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Quan for Type 2 Diabetes | Experimental | Behavioral: Tai Chi Quandiabetic patients care education and Tai Chi Quan training, including 10-minute warm-up, 40-minute Tai Chi lesson, and 10-minute cool-down exercise in the training, twice a week for 12 weeks. |
| Control Group for Type 2 Diabetes | No intervention | –diabetic patients care education |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40~80 years old
- Diagnosed type 2 diabetes mellitus, and without changing dietary pattern and medical treatment for blood glucose or blood lipid.
- Consciousness clear and is voluntary to attend the project and with the agreement.
- The functional movement ability is independent
Key exclusion criteria (4 listed)
- Pregnant or plan to be pregnant in six months, and breast feeding.
- Severe complication in six months such as myocardial infarction, stroke, severe traumatic injury, major surgery. Other diseases evaluated by the doctor that are not suitable for the project.
- Evaluated that the compliance for the intervention is not appropriate.
- The blood glucose > 300mg/dl and unable to do vigorous exercise.
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 |
|---|---|---|
| Tai Chi Quanthe first section of Yang style 108 form, including 10-minute warm-up, 40-minute training, and 10-minute cool-down exercise, twice a week | Behavioural | Tai Chi Quan for Type 2 Diabetes |
Primary outcome
Hemoglobin
Time frame: change from Baseline to 12 weeks
HbA1c
11 secondary outcomes
fasting blood glucose
Time frame: change from Baseline to 12 weeks
triglycerides
Time frame: change from Baseline to 12 weeks
high and low density lipoprotein
Time frame: change from Baseline to 12 weeks
creatinine
Time frame: change from Baseline to 12 weeks
estimated Glomerular Filtration Rate (eGFR)
Time frame: change from Baseline to 12 weeks
Glutamic-Pyruvic Transaminase (GPT)
Time frame: change from Baseline to 12 weeks
urine albumin/creatinine ratio (ACR)
Time frame: change from Baseline to 12 weeks
quality of life
Time frame: change from Baseline to 12 weeks
heart rate variability
Time frame: change from Baseline to 12 weeks
low frequency (LF)
Time frame: change from Baseline to 12 weeks
high frequency (HF)
Time frame: change from Baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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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.
Chien-Jung Huang, Bachelor study chair
Taipei City 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 Tai Chi Quan in people with Type 2 Diabetes Mellitus, run by Taipei City 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: status not confirmed, as of the sponsor's last update on 19 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Jung Huang, Bachelor ((+886)2-2591-6681 ext. 1262, DAI62@tpech.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: change from Baseline to 12 weeks). 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 19 Jun 2018.