Yoga for the Treatment of Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Restorative Yoga for Therapy of the Metabolic Syndrome: A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605436
• Other study ID #: H9377-29543-02
• Secondary ID: CHR#H9377-29543-
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2008
• Last updated: January 30, 2008
• Start date: October 2006
• Est. completion date: June 2007

Study information

• Verified date: January 2008
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We tested the following hypotheses:

1. That a standardized yoga therapy will improve insulin sensitivity (primary outcome), and other features of the metabolic syndrome such as hypertension and dyslipidemia (secondary outcomes), we will perform a 2-hour oral glucose tolerance test, fasting blood tests, and a physical examination before and after randomization of subjects to a 10-week yoga therapy intervention or wait-list control group.

2. That a yoga therapy is feasible in overweight and underactive individuals with the metabolic syndrome, that adherence to a yoga intervention is acceptable, and that yoga therapy is associated with improved quality of life, we will assess the adherence to twice-weekly yoga group sessions (for weeks1-5) and weekly yoga group sessions (for weeks 6-10), frequency of home yoga therapy practice, and self-reported quality of life before and after the intervention in both treatment groups.

3. To elucidate a potential mechanism for the effect of yoga on changes in insulin resistance by evaluating markers of inflammation from adipose tissue (adipocytokines). We hypothesize that these biochemical parameters will show modest improvement with yoga therapy and that changes in these parameters will be associated with improvements in insulin sensitivity.

Description:

Study Interventions: There will be a 12-week intervention period.

1. Yoga Therapy Group: Those randomized to yoga therapy will receive twice-weekly group yoga sessions at the Osher Center for the entire intervention period. The yoga postures and breathing techniques will be taught by a qualified and certified yoga instructor using a standardized protocol that was determined by a Yoga Expert Panel. Each group yoga session will take approximately 90 minutes. Participants will also be required to practice yoga at home at least 3 times per week, and be given yoga materials (mat, blocks, straps), an instruction manual, and a video for their use at home. They will be asked to keep a calendar log of the dates/times that they practiced yoga at home. This group will also receive a 20-30 minute session with a counselor to discuss Standard Health Education at the beginning of the 12-week intervention. This session will be similar to the control group intervention.

2. Standard Health Education Group: Participants assigned to the standard health education group will receive an individual 20-30 minute session with a trained research associate within a week of their baseline visit. In this session, participants will be informed of the importance of a healthy lifestyle, given written information of the Food Guide Pyramid12 and told to follow the equivalent of the National Cholesterol Education Program Step I diet13. They will be counseled to reduce weight and increase physical activity. This is similar to the intervention given to the "Standard Lifestyle Group" in the Diabetes Prevention Program4.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

1. to be between the ages of 30 and 65 years,

2. fulfill at least three criteria for the metabolic syndrome per the NCEP guidelines:

• waist circumference (>88 cm for women; >102 cm for men),

• HDL-cholesterol (<50 mg/dl for women; <40 mg/dl for men),

• triglycerides >=150 mg/dL

• fasting glucose >=100 mg/dL, and/or

• high blood pressure (>=130/>=85 or use of antihypertensive medication), and

3. report an underactive or sedentary lifestyle defined as accumulating less than 30 minutes of moderate intensity endurance exercise 5 days per week.

Exclusion Criteria:

1. Pregnancy or lactation

2. Coronary heart disease (defined as a myocardial infarction or cardiac intervention with percutaneous transluminal catheterization or coronary artery bypass graft surgery) event or hospitalization in the past 6 months

3. Chronic illnesses: cancer, kidney disease, cirrhosis, rheumatogic diseases, or chronic infections

4. Current use of these medications: oral diabetes medications, insulin, steroid hormones, oral contraceptives, hormone replacement therapy, niacin, fibrates.

5. Regular participation (>1/week) yoga for past 3 months or concurrent use of yoga

6. Current major psychiatric illness, cognitive impairment, or substance abuse

7. Plans to move out of the study region within 6 months

8. Life-expectancy of < 6 months

9. Concurrent enrollment in any other studies, experimental therapies, or blinded treatments

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• Restorative yoga therapy
3-hour workshop at study initiation. Then twice-weekly group yoga classes for 5 weeks, then once-weekly group yoga classes for 5 weeks. Home yoga practice for 90 minutes/week throughout the 10 week trial.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Cliff Lede Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting plasma glucose level		10 weeks	No
Secondary	Feasability of yoga postures		10 weeks	Yes
Secondary	Adherence to protocol		10 weeks	No
Secondary	Blood pressure		10 weeks	No
Secondary	Insulin sensitivity		10 weeks	No
Secondary	Weight		10 weeks	No
Secondary	Waist circumference		10 weeks	No
Secondary	Heart rate variability		10 weeks	No