Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT02607566
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2015-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga as a Complementary Therapy for Adults With Type 2 Diabetes
Sponsor:
The Miriam Hospital
Organization:
Study Overview
Official Title:
Yoga as a Complementary Therapy for Type 2 Diabetes: An Initial Investigation
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: