Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Yoga, Walking, Stress, exercise, glycemic control
Brief summary
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
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.
Interventions
BEHAVIORALYoga
BEHAVIORALStandard Exercise Program
twice weekly aerobic exercise program, 60 minutes for 12 weeks
Sponsors
University of Massachusetts, Lowell
Rhode Island Hospital
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability as measured by session attendance | 12 weeks | Number of sessions attended |
| Feasibility as measured by study completion | 6 months | Percent of enrolled subjects completing all assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in diabetes-related distress as measured by Diabetes Related Distress Survey | Baseline to Week 12 | Percent change in score on the Diabetes Related Distress Survey (Polonsky et al., 1995) |
| Changes in Salivary Cortisol (ug/dL) between baseline and week 12 | Baseline to Week 12 | Saliva samples collected at baseline and week 12 will be assayed for cortisol levels (ug/dL) |
| HbA1c | 6 months | HbA1c levels from blood draws |
| Diabetes Self-Care | 12 weeks | Surveys of diabetes related self care activities |
Countries
United States
Outcome results
None listed