Yoga as a Complementary Therapy for Adults With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607566
• Other study ID #: R21AT008830
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: November 2015
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Yoga

• Standard Exercise Program
twice weekly aerobic exercise program, 60 minutes for 12 weeks

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island
United States	The Miriam Hospital- CORO building	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
The Miriam Hospital	Rhode Island Hospital, University of Massachusetts, Lowell

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bock BC, Thind H, Fava JL, Dunsiger S, Guthrie KM, Stroud L, Gopalakrishnan G, Sillice M, Wu W. Feasibility of yoga as a complementary therapy for patients with type 2 diabetes: The Healthy Active and in Control (HA1C) study. Complement Ther Med. 2019 Feb — View Citation

Thind H, Fava JL, Guthrie KM, Stroud L, Gopalakrishnan G, Sillice M, Gidron N, Bock BC. Yoga as a Complementary Therapy for Adults with Type 2 Diabetes: Design and Rationale of the Healthy, Active, and in Control (HA1C) Study. Int J Yoga Therap. 2018 Nov;28(1):123-132. doi: 10.17761/2018-00026. Epub 2018 Aug 21. — View Citation

Thind H, Guthrie KM, Horowitz S, Conrad M, Bock BC. "I can do almost anything": The experience of adults with type 2 diabetes with a yoga intervention. Complement Ther Clin Pract. 2019 Feb;34:116-122. doi: 10.1016/j.ctcp.2018.11.011. Epub 2018 Nov 16. — View Citation

Thind H, Lantini R, Balletto BL, Donahue ML, Salmoirago-Blotcher E, Bock BC, Scott-Sheldon LAJ. The effects of yoga among adults with type 2 diabetes: A systematic review and meta-analysis. Prev Med. 2017 Dec;105:116-126. doi: 10.1016/j.ypmed.2017.08.017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability as measured by session attendance	Number of sessions attended	12 weeks
Primary	Feasibility as measured by study completion	Percent of enrolled subjects completing all assessments	6 months
Secondary	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
Secondary	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
Secondary	HbA1c	HbA1c levels from blood draws	6 months
Secondary	Diabetes Self-Care	Surveys of diabetes related self care activities	12 weeks