Expired Study
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San Francisco, California 94115


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

H9377-29543-02


NCT ID:

NCT00605436


Secondary ID:

CHR#H9377-29543-02


Study Acronym:


Brief Title:

Yoga for the Treatment of Metabolic Syndrome


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

30 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

26


Enrollment Type:

Actual


Overall Contact Information

Official Name:Alka M. Kanaya, MD
Principal Investigator
University of California, San Francisco

Study Dates

Start Date:October 2006
Completion Date:June 2007
Completion Type:Actual
Primary Completion Date:April 2007
Primary Completion Type:Actual
Verification Date:January 2008
Last Changed Date:January 30, 2008
First Received Date:January 16, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Heart rate variability
Time Frame:10 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Waist circumference
Time Frame:10 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Weight
Time Frame:10 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Insulin sensitivity
Time Frame:10 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Blood pressure
Time Frame:10 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Adherence to protocol
Time Frame:10 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Feasability of yoga postures
Time Frame:10 weeks
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Fasting plasma glucose level
Time Frame:10 weeks
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Restorative yoga therapy
Description: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.
Arm Name:A

Study Arms

Study Arm Type:No Intervention
Arm Name:B
Description:The control group is a wait-list control group with no active intervention.
Study Arm Type:Experimental
Arm Name:A
Description:Restorative yoga therapy group: one orientation workshop for 3 hours, then twice-weekly group yoga therapy classes for first 5 weeks followed by once-weekly group yoga classes for another 5 weeks. The group will also be asked to practice their yoga postures at home for 30 minutes three times per week.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco
Agency Class:Other
Agency Type:Collaborator
Agency Name:UCSF Mt. Zion hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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