Yoga as a Complementary Therapy for Adults With Type 2 Diabetes

Lifespan

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Yoga; Behavioral: Standard Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02607566

R21AT008830

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Iyengar Yoga

Experimental group

Description:

Iyengar Yoga Intervention twice weekly for 60 minutes for 12 weeks.

Treatment:

Behavioral: Yoga

Standard Exercise Program

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Exercise Program