Effects of Yoga on Metabolic Syndrome

NCT02140203 | Completed DMC

• 1 other identifier: MetsYoga
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Metabolic Syndrome; Waist circumference; blood pressure; triglyceride; HDL

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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

  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.

  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.

  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.

  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.

  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

  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.

  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.

  One year

Secondary Outcomes (2)

• Change in self-reported stress and depression levels

  Six Months

• Change in Self-reported stress and depression levels

  One year

Study Arms (4)

Young Yoga Group

ACTIVE COMPARATOR

People who are younger than 60 year-old They have received Yoga training in one-year experimental period

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

Other: Yoga Training

Interventions

Yoga Training OTHER

one-year experimental training (three times per week and one hour per session)

Also known as: Hatha Yoga Training

Aged Yoga Group; Young Yoga Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Dementia
• Mental disorders
• Severe or acute cardiovascular illnesses
• Post-stroke,
• Neuromusculoskeletal illnesses
• Major orthopaedic diagnosis in the lower back
• 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

Sponsors & Collaborators

• Angus Yu: lead
• The Hong Kong Jockey Club Charities Trust: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 852, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Parco MF Siu, PHD

  Associate Professor, Department of Health Technology and Informatics, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project Assistant

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 16, 2014
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2013
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

CN (1)