Metabolic SyndromeNCT02140203
Effects of Yoga on Metabolic Syndrome
A study testing Yoga Training in people with Metabolic Syndrome, run by Angus Yu at 1 site in China.
Trial summary
Metabolic syndrome (MetS) is a clustering of cardiovascular risk factors characterizing central obesity, insulin resistance, dyslipidemia and high blood pressure. The concept of MetS represents the pre-cardiovascular and pre-diabetic pathologic conditions, which has been a useful tool in prognosing the development of… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Yoga Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Aug 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MetS is defined as having three or more (>= 3) of the following conditions:
- Central obesity - Waist circumference >= 90 cm (Asian male); 80 cm (Asian female)
- High blood pressure - Systolic blood pressure/diastolic blood pressure >= 130/85 mmHg or use of hypertension drug
- Elevated blood glucose - Fasting blood glucose >= 100 mg/dL or use of hyperglycemia drug
- Elevated blood triglyceride - Blood triglyceride >= 150 mg/dL
- Reduced HDL-cholesterol - HDL-C <= 40 mg/dL (male); <= 50 mg/dL (female)
Who cannot join
- Dementia
- Mental disorders
- Severe or acute cardiovascular illnesses
- Post-stroke,
- Neuromusculoskeletal illnesses
- Major orthopaedic diagnosis in the lower back
Show all 18Show fewer
- Pelvis or lower extremities
- Severe rheumatoid arthritis
- Osteoarthritis
- Pulmonary illnesses
- Immobile
- Wheelchair users
- Undertaking drug therapy treating metabolic abnormalities
- Acute medical illness
- Symptomatic heart disease
- Symptomatic lung disease
- Physical conditions not suitable for exercise training, and tobacco users
- Regular physical activities (>= 3 days per week of moderate exercise intensity >= 30 minutes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Yoga on Metabolic Abnormalities Outcomes in Middle-Aged and Older Adults With Metabolic Syndrome
Metabolic syndrome (MetS) is a clustering of cardiovascular risk factors characterizing central obesity, insulin resistance, dyslipidemia and high blood pressure. The concept of MetS represents the pre-cardiovascular and pre-diabetic pathologic conditions, which has been a useful tool in prognosing the development of cardiovascular disease and diabetes mellitus. Importantly, interventions applied at the pre-pathologic stage with MetS would be of great clinical and health significance in achieving better preventive and therapeutic outcomes. Yoga, a mind-body exercise, has been suggested to have beneficial effects on dyslipidemia, hypertension and diabetes. A pilot study has demonstrated the trends in the improvement of metabolic parameters in middle-aged adults with MetS but the findings are inconclusive because of the small sample size and brief yoga follow-up period (i.e., 2-month). In addition to the needs of a better designed randomized controlled trial in studying the beneficial effect of yoga in controlling MetS in middle-aged individuals, the investigation on yoga and MetS in elderly population has been lacking. This is important as the potential use of yoga as lifestyle modification in elderly individuals with MetS will result in significant reduction of the prevalence of cardiovascular disease and diabetes. Thus, this study aims to examine the efficacy of yoga exercise in improving metabolic abnormalities in middle-aged and older adults with MetS. In addition to elderly, middle-aged adults are included in the present investigation because of the idea that cardiovascular diseases and diabetes with aging can be mostly prevented by intervention at the middle-age. A randomized controlled trial with repeated measure design will be conducted to examine the effect of 1-year regular yoga training on the MetS parameters in middle-aged and older individuals who are 30-60 and 60-80 years of age, respectively. Primary outcome measures include waist circumference, systolic/diastolic blood pressure, blood glucose, triglyceride, and lipid cholesterol profile whereas secondary outcome measures include self-reported stress and depression levels. This study is anticipated to provide valuable information in exploring the therapeutic role of yoga in managing MetS. As yoga exercise is an economical regimen which can be easily and readily applied to large scale of target population, it is of hope to be practically useful to relieve the burden on cardiovascular disease and diabetes by introducing yoga lifestyle to the management of MetS.
- Conditions
- Metabolic Syndrome
- Being tested
- Yoga Training
- Keywords
- Metabolic Syndrome, Waist circumference, blood pressure, triglyceride, HDL
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga TrainingOther
Also called Hatha Yoga Training
one-year experimental training (three times per week and one hour per session)
| Study group | Role | What they receive |
|---|---|---|
| Young Yoga Group | Active comparator | People who are younger than 60 year-old They have received Yoga training in one-year experimental period Receives: Other: Yoga Training |
| Young Control Group | No intervention | People who are younger than 60 year-old No Yoga training through out the one-year experimental period |
| Aged Control Group | No intervention | People who are equal or older than 60 year-old They have not received any yoga training during the one-year experimental period |
| Aged Yoga Group | Active comparator | People who are equal or older than 60 year-old They have received any yoga training during the one-year experimental period Receives: Other: Yoga Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in waist circumference
The operational definition of waist circumference is the measure of circumference at the waist area. This is a commonly used indicator for recognizing central obesity. The waist circumference will be determined by using tape with metric scale. To determine the waist circumference, the upper hip bone will be located and a measuring tape will be placed around the abdomen. The tape measure will be horizontal and the measuring tape will not be snug but without causing compressions on the skin.
Measured: Six Months
Change in systolic/diastolic blood pressure
Resting blood pressure measurement will be performed after the subject has taken 15-minute rest in the laboratory by using an electronic blood pressure monitor. Both the systolic and diastolic blood pressure will be obtained with the cuff over brachial artery region at the level of heart.
Measured: Six Months
Change in blood glucose
Measurements will be performed on the glucose and insulin level in venous blood sample collected after overnight fast. Subjects will be asked to come to the laboratory after an overnight ~10 hours fasting. Before each resting blood sampling, subjects will be requested to sit in a quiet environment for 15 minutes prior to blood collection. Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for glucose
Measured: Six Months
Change in triglyceride
Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for triglyceride.
Measured: Six Months
Change in lipoprotein
The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. Measurements will be performed on HDL-C level in the collected venous blood samples.
Measured: Six Months
Change in waist circumference
The operational definition of waist circumference is the measure of circumference at the waist area. This is a commonly used indicator for recognizing central obesity. The waist circumference will be determined by using tape with metric scale. To determine the waist circumference, the upper hip bone will be located and a measuring tape will be placed around the abdomen. The tape measure will be horizontal and the measuring tape will not be snug but without causing compressions on the skin.
Measured: One year
Change in systolic/diastolic pressure
Resting blood pressure measurement will be performed after the subject has taken 15-minute rest in the laboratory by using an electronic blood pressure monitor. Both the systolic and diastolic blood pressure will be obtained with the cuff over brachial artery region at the level of heart.
Measured: One year
Change in blood glucose
Measurements will be performed on the glucose and insulin level in venous blood sample collected after overnight fast. Subjects will be asked to come to the laboratory after an overnight ~10 hours fasting. Before each resting blood sampling, subjects will be requested to sit in a quiet environment for 15 minutes prior to blood collection. Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for glucose
Measured: One year
Change in triglyceride
Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for triglyceride.
Measured: One year
Change in lipoprotein
The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. Measurements will be performed on HDL-C level in the collected venous blood samples.
Measured: One year
Secondary outcomes (2)
Change in self-reported stress and depression levels
Self-reported stress and depression levels are proposed to be the secondary outcome measures because the stress and depression levels could be improved by yoga intervention which might have beneficial effects on MetS parameters indirectly. The indicator of stress level will be adopted to estimate the mental health in this project. The Patton Type A personality questionnaire will be used to examine the stress level. The Center for Epidemiologic Studies Depression Scale (CES-D) will be used to estimate the depression level of the subjects.
Measured: Six Months
Change in Self-reported stress and depression levels
Self-reported stress and depression levels are proposed to be the secondary outcome measures because the stress and depression levels could be improved by yoga intervention which might have beneficial effects on MetS parameters indirectly. The indicator of stress level will be adopted to estimate the mental health in this project. The Patton Type A personality questionnaire will be used to examine the stress level. The Center for Epidemiologic Studies Depression Scale (CES-D) will be used to estimate the depression level of the subjects.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startJul 2010
- Primary completionAug 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angus Yu
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Responsible party
- Sponsor-investigator, Angus Yu, The Hong Kong Polytechnic University
- Investigators
- Parco MF Siu, PHD, Principal investigator, Associate Professor, Department of Health Technology and Informatics, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140203
- Sponsor's protocol ID
- MetsYoga
- Status last verified
- May 2014
- First submitted
- 13 May 2014
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yoga on Metabolic Abnormalities Outcomes in Middle-Aged and Older Adults With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02140203
- Acronym / sponsor ID
- MetsYoga
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Waist circumference, blood pressure, triglyceride, HDL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Angus YuUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 May 2014 (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.
Metabolic syndrome (MetS) is a clustering of cardiovascular risk factors characterizing central obesity, insulin resistance, dyslipidemia and high blood pressure. The concept of MetS represents the pre-cardiovascular and pre-diabetic pathologic conditions, which has been a useful tool in prognosing the development of cardiovascular disease and diabetes mellitus. Importantly, interventions applied at the pre-pathologic stage with MetS would be of great clinical and health significance in achieving better preventive and therapeutic outcomes. Yoga, a mind-body exercise, has been suggested to have beneficial effects on dyslipidemia, hypertension and diabetes. A pilot study has demonstrated the trends in the improvement of metabolic parameters in middle-aged adults with MetS but the findings are inconclusive because of the small sample size and brief yoga follow-up period (i.e., 2-month). In addition to the needs of a better designed randomized controlled trial in studying the beneficial effect of yoga in controlling MetS in middle-aged individuals, the investigation on yoga and MetS in elderly population has been lacking. This is important as the potential use of yoga as lifestyle modification in elderly individuals with MetS will result in significant reduction of the prevalence of cardiovascular disease and diabetes. Thus, this study aims to examine the efficacy of yoga exercise in improving metabolic abnormalities in middle-aged and older adults with MetS. In addition to elderly, middle-aged adults are included in the present investigation because of the idea that cardiovascular diseases and diabetes with aging can be mostly prevented by intervention at the middle-age. A randomized controlled trial with repeated measure design will be conducted to examine the effect of 1-year regular yoga training on the MetS parameters in middle-aged and older individuals who are 30-60 and 60-80 years of age, respectively. Primary outcome measures include waist circumference, systolic/diastolic blood pressure, blood glucose, triglyceride, and lipid cholesterol profile whereas secondary outcome measures include self-reported stress and depression levels. This study is anticipated to provide valuable information in exploring the therapeutic role of yoga in managing MetS. As yoga exercise is an economical regimen which can be easily and readily applied to large scale of target population, it is of hope to be practically useful to relieve the burden on cardiovascular disease and diabetes by introducing yoga lifestyle to the management of MetS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young Yoga Group | Active comparator | Other: Yoga TrainingPeople who are younger than 60 year-old They have received Yoga training in one-year experimental period |
| Young Control Group | No intervention | –People who are younger than 60 year-old No Yoga training through out the one-year experimental period |
| Aged Control Group | No intervention | –People who are equal or older than 60 year-old They have not received any yoga training during the one-year experimental period |
| Aged Yoga Group | Active comparator | Other: Yoga TrainingPeople who are equal or older than 60 year-old They have received any yoga training during the one-year experimental period |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Central obesity - Waist circumference >= 90 cm (Asian male); 80 cm (Asian female)
- High blood pressure - Systolic blood pressure/diastolic blood pressure >= 130/85 mmHg or use of hypertension drug
- Elevated blood glucose - Fasting blood glucose >= 100 mg/dL or use of hyperglycemia drug
- Elevated blood triglyceride - Blood triglyceride >= 150 mg/dL
- Reduced HDL-cholesterol - HDL-C <= 40 mg/dL (male); <= 50 mg/dL (female)
Key exclusion criteria (18 listed)
- Dementia
- Mental disorders
- Severe or acute cardiovascular illnesses
- Post-stroke,
- Neuromusculoskeletal illnesses
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 |
|---|---|---|
| Yoga TrainingAlso: Hatha Yoga Trainingone-year experimental training (three times per week and one hour per session) | Other | Aged Yoga Group, Young Yoga Group |
Primary outcome
Change in waist circumference
Time frame: Six Months
The operational definition of waist circumference is the measure of circumference at the waist area. This is a commonly used indicator for recognizing central obesity. The waist circumference will be determined by using tape with metric scale. To determine the waist circumference, the upper hip bone will be located and a measuring tape will be placed around the abdomen. The tape measure will be horizontal and the measuring tape will not be snug but without causing compressions on the skin.
Change in systolic/diastolic blood pressure
Time frame: Six Months
Resting blood pressure measurement will be performed after the subject has taken 15-minute rest in the laboratory by using an electronic blood pressure monitor. Both the systolic and diastolic blood pressure will be obtained with the cuff over brachial artery region at the level of heart.
Change in blood glucose
Time frame: Six Months
Measurements will be performed on the glucose and insulin level in venous blood sample collected after overnight fast. Subjects will be asked to come to the laboratory after an overnight ~10 hours fasting. Before each resting blood sampling, subjects will be requested to sit in a quiet environment for 15 minutes prior to blood collection. Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for glucose
Change in triglyceride
Time frame: Six Months
Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for triglyceride.
Change in lipoprotein
Time frame: Six Months
The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. Measurements will be performed on HDL-C level in the collected venous blood samples.
Change in waist circumference
Time frame: One year
The operational definition of waist circumference is the measure of circumference at the waist area. This is a commonly used indicator for recognizing central obesity. The waist circumference will be determined by using tape with metric scale. To determine the waist circumference, the upper hip bone will be located and a measuring tape will be placed around the abdomen. The tape measure will be horizontal and the measuring tape will not be snug but without causing compressions on the skin.
Change in systolic/diastolic pressure
Time frame: One year
Resting blood pressure measurement will be performed after the subject has taken 15-minute rest in the laboratory by using an electronic blood pressure monitor. Both the systolic and diastolic blood pressure will be obtained with the cuff over brachial artery region at the level of heart.
Change in blood glucose
Time frame: One year
Measurements will be performed on the glucose and insulin level in venous blood sample collected after overnight fast. Subjects will be asked to come to the laboratory after an overnight ~10 hours fasting. Before each resting blood sampling, subjects will be requested to sit in a quiet environment for 15 minutes prior to blood collection. Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for glucose
Change in triglyceride
Time frame: One year
Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for triglyceride.
Change in lipoprotein
Time frame: One year
The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. Measurements will be performed on HDL-C level in the collected venous blood samples.
2 secondary outcomes
Change in self-reported stress and depression levels
Time frame: Six Months
Change in Self-reported stress and depression levels
Time frame: One year
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 16 May 2014.
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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.
Parco MF Siu, PHD principal investigator
Associate Professor, Department of Health Technology and Informatics, The Hong Kong Polytechnic 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 Yoga Training in people with Metabolic Syndrome, run by Angus Yu at 1 site in China.
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 6 inclusion and 18 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 16 May 2014. 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 China. 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 waist circumference (time frame: Six Months). The study lists 10 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 16 May 2014.