NCT Number: NCT02607566
Yoga as a Complementary Therapy for Adults With Type 2 Diabetes
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
The Miriam Hospital, Providence, Rhode Island, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Standard Exercise Program
Behavioraltwice weekly aerobic exercise program, 60 minutes for 12 weeks
Primary outcomes
-
Acceptability as measured by session attendance
Time frame: 12 weeks
Number of sessions attended
-
Feasibility as measured by study completion
Time frame: 6 months
Percent of enrolled subjects completing all assessments
Secondary outcomes
-
Changes in diabetes-related distress as measured by Diabetes Related Distress Survey
Time frame: 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
Time frame: Baseline to Week 12
Saliva samples collected at baseline and week 12 will be assayed for cortisol levels (ug/dL)
-
HbA1c
Time frame: 6 months
HbA1c levels from blood draws
-
Diabetes Self-Care
Time frame: 12 weeks
Surveys of diabetes related self care activities
Sponsors and collaborators
Lead sponsor
The Miriam Hospital
Other
Collaborators
- Rhode Island Hospital
- University of Massachusetts, Lowell
Registry information
Official study title
Yoga as a Complementary Therapy for Type 2 Diabetes: An Initial Investigation
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Nov 18, 2015
- Registry last updated
- Apr 25, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
A Randomized Trial to Slow the Progression of Diabetes
NCT03800680
Behavior, Diabetes Mellitus
Singapore
View Trial DetailsImproving Diabetes Outcomes With Activity, Nutrition and Medication
NCT00179374
Behavior, Diabetes Mellitus
The Bronx, New York, United States
View Trial DetailsEffects of Different Mode of Exercise Training on Type 2 Diabetes
NCT01000519
Behavior, Diabetes Mellitus
Singapore
View Trial DetailsTelerehabilitation Intervention to Promote Exercise for Diabetes
NCT00334113
Behavior, Body Weight
Boston, Massachusetts, United States
View Trial Details