Yoga for the Treatment of Metabolic Syndrome

NCT00605436 | Completed Phase 1

• 2 other identifiers: H9377-29543-02CHR#H9377-29543-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

We tested the following hypotheses:

1. 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. 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. 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.

Conditions

Metabolic Syndrome

Keywords

overweight; sedentary; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Fasting plasma glucose level

  10 weeks

Secondary Outcomes (7)

• Feasability of yoga postures

  10 weeks

• Adherence to protocol

  10 weeks

• Blood pressure

  10 weeks

• Insulin sensitivity

  10 weeks

• Weight

  10 weeks

Study Arms (2)

A

EXPERIMENTAL

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.

Behavioral: Restorative yoga therapy

B

NO INTERVENTION

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

Interventions

Restorative yoga therapy BEHAVIORAL

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.

A

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Cliff Lede Foundation: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Overweight; Sedentary Behavior

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Alka M. Kanaya, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Deborah Grady, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 31, 2008
• Study Start: October 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 31, 2008

Record last verified: 2008-01

Locations

US (1)