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Yoga for the Treatment of Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Restorative yoga therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring overweight, sedentary, metabolic syndrome

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm 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.

The control group is a wait-list control group with no active intervention.

Outcomes

Primary Outcome Measures

Fasting plasma glucose level

Secondary Outcome Measures

Feasability of yoga postures
Adherence to protocol
Blood pressure
Insulin sensitivity
Weight
Waist circumference
Heart rate variability

Full Information

First Posted
January 16, 2008
Last Updated
January 30, 2008
Sponsor
University of California, San Francisco
Collaborators
Cliff Lede Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00605436
Brief Title
Yoga for the Treatment of Metabolic Syndrome
Official Title
Restorative Yoga for Therapy of the Metabolic Syndrome: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
Cliff Lede Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We tested the following hypotheses: 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. 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. 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.
Detailed Description
Study Interventions: There will be a 12-week intervention period. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
overweight, sedentary, metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm 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.
Arm Title
B
Arm Type
No Intervention
Arm Description
The control group is a wait-list control group with no active intervention.
Intervention Type
Behavioral
Intervention Name(s)
Restorative yoga therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Fasting plasma glucose level
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Feasability of yoga postures
Time Frame
10 weeks
Title
Adherence to protocol
Time Frame
10 weeks
Title
Blood pressure
Time Frame
10 weeks
Title
Insulin sensitivity
Time Frame
10 weeks
Title
Weight
Time Frame
10 weeks
Title
Waist circumference
Time Frame
10 weeks
Title
Heart rate variability
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: to be between the ages of 30 and 65 years, 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 report an underactive or sedentary lifestyle defined as accumulating less than 30 minutes of moderate intensity endurance exercise 5 days per week. Exclusion Criteria: Pregnancy or lactation 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 Chronic illnesses: cancer, kidney disease, cirrhosis, rheumatogic diseases, or chronic infections Current use of these medications: oral diabetes medications, insulin, steroid hormones, oral contraceptives, hormone replacement therapy, niacin, fibrates. Regular participation (>1/week) yoga for past 3 months or concurrent use of yoga Current major psychiatric illness, cognitive impairment, or substance abuse Plans to move out of the study region within 6 months Life-expectancy of < 6 months Concurrent enrollment in any other studies, experimental therapies, or blinded treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alka M. Kanaya, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah Grady, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Yoga for the Treatment of Metabolic Syndrome

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