Clinical trial NCT02607566: Yoga as a Complementary Therapy for Adults With Type 2 Diabetes
Official title: Yoga as a Complementary Therapy for Type 2 Diabetes: An Initial Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Yoga
Walking
Stress
exercise
glycemic control
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Lowell
name: Rhode Island Hospital
First posted: 2015-11-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability as measured by session attendance
timeFrame: 12 weeks
measure: Feasibility as measured by study completion
timeFrame: 6 months
Secondary outcomes:
measure: Changes in diabetes-related distress as measured by Diabetes Related Distress Survey
timeFrame: Baseline to Week 12
measure: Changes in Salivary Cortisol (ug/dL) between baseline and week 12
timeFrame: Baseline to Week 12
measure: HbA1c
timeFrame: 6 months
measure: Diabetes Self-Care
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital- CORO building
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Beth Bock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. No abstract available.
citation: 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;42:125-131. doi: 10.1016/j.ctim.2018.09.019. Epub 2018 Sep 26.
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. Epub 2017 Sep 4.