Yoga as a Complementary Therapy for Adults With Type 2 Diabetes

Study Overview
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Brief Summary
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This study will examine the feasibility and acceptability of a twice weekly yoga program for adults with type 2 diabetes. Changes in perceived stress, salivary cortisol, and HbA1c will also be examined.

Detailed Description
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The purpose of the current proposal is to test a yoga intervention for adults with T2DM and to gather data on the feasibility and acceptability of yoga compared to a contact control for glycemic control. The investigators will conduct a pilot randomized controlled study with participants randomly assigned to 1) Yoga intervention, or 2) A standard exercise (SE) group program (comparison-control). Focus groups will be conducted with participants at the end of the intervention to identify facilitators and barriers to yoga practice and to examine their perceptions and beliefs about yoga and its relationship to stress and diabetes management. The investigators will explore the effect of yoga on stress (biomarker = salivary cortisol) that may act as a mechanism of action underlying the efficacy of yoga for improved glycemic control. The investigators will also measure HbA1c levels, fasting and postprandial plasma glucose at baseline, end of treatment (12-weeks), 6- and 9-month follow-ups. Study feasibility and acceptability will be assessed using participant recruitment, attendance and retention rates, and compliance with study protocols and satisfaction with the program. Participants will also attend a focus-group discussion of the program at the end of treatment. Results from this study will provide scientific basis for a future larger clinical trial. Yoga, if found to offer advantages for glycemic control, can have potential for high impact on current practices of diabetes management.

Official Title
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Yoga as a Complementary Therapy for Type 2 Diabetes: An Initial Investigation

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Yoga
* Behavioral: Standard Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes for more than 6 months HbA1c > 6.5 Body Mass Index < 42 Exclusion Criteria: Serious co-morbid condition (e.g. uncontrolled hypertension, glaucoma, heart failure) Complications of diabetes (e.g. diabetic retinopathy, neuropathy, nephropathy) Serious psychiatric disorder (e.g. psychosis, major depression, panic attacks, suicidality, or substance dependence) Body Mass Index of 42 or greater Pregnancy or planned pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iyengar Yoga<br>Iyengar Yoga Intervention twice weekly for 60 minutes for 12 weeks. | Behavioral: Yoga<br> <br> |
| Active Comparator: Standard Exercise Program<br>professionally supervised program of aerobic exercise including use of an indoor walking track, treadmills, stationary bicycles and elliptical machines, held for 60 minutes twice weekly for 12 weeks | Behavioral: Standard Exercise Program<br>* twice weekly aerobic exercise program, 60 minutes for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability as measured by session attendance | Number of sessions attended | 12 weeks | 
| Feasibility as measured by study completion | Percent of enrolled subjects completing all assessments | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in diabetes-related distress as measured by Diabetes Related Distress Survey | Percent change in score on the Diabetes Related Distress Survey (Polonsky et al., 1995) | Baseline to Week 12 | 
| Changes in Salivary Cortisol (ug/dL) between baseline and week 12 | Saliva samples collected at baseline and week 12 will be assayed for cortisol levels (ug/dL) | Baseline to Week 12 | 
| HbA1c | HbA1c levels from blood draws | 6 months | 
| Diabetes Self-Care | Surveys of diabetes related self care activities | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Yoga, Walking, Stress, exercise, glycemic control