Diabetes Mellitus, Type 2NCT02607566
Yoga as a Complementary Therapy for Adults With Type 2 Diabetes
A study testing Yoga and Standard Exercise Program in people with Diabetes Mellitus, Type 2, run by The Miriam Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Yoga and Standard Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes for more than 6 months
- HbA1c > 6.5
- Body Mass Index < 42
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Miriam Hospital- CORO building
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: Yoga as a Complementary Therapy for Type 2 Diabetes: An Initial Investigation
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Yoga, Standard Exercise Program
- Keywords
- Diabetes, Yoga, Walking, Stress, exercise, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Standard Exercise ProgramBehavioural
twice weekly aerobic exercise program, 60 minutes for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Iyengar Yoga | Experimental | Iyengar Yoga Intervention twice weekly for 60 minutes for 12 weeks. Receives: Behavioral: Yoga |
| Standard Exercise Program | Active comparator | professionally supervised program of aerobic exercise including use of an indoor walking track, treadmills, stationary bicycles and elliptical machines, held for 60 minutes twice weekly for 12 weeks Receives: Behavioral: Standard Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability as measured by session attendance
Number of sessions attended
Measured: 12 weeks
Feasibility as measured by study completion
Percent of enrolled subjects completing all assessments
Measured: 6 months
Secondary outcomes (4)
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)
Measured: Baseline to Week 12
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)
Measured: Baseline to Week 12
HbA1c
HbA1c levels from blood draws
Measured: 6 months
Diabetes Self-Care
Surveys of diabetes related self care activities
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Lowell, Rhode Island Hospital
- Responsible party
- Sponsor
- Investigators
- Beth Bock, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607566
- Sponsor's protocol ID
- R21AT008830
- Status last verified
- Nov 2015
- First submitted
- 12 Nov 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30130144Thind 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.
PubMed 30712714Bock 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.
PubMed 30670230Thind 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.
PubMed 28882745
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga as a Complementary Therapy for Type 2 Diabetes: An Initial Investigation
- ClinicalTrials.gov ID
- NCT02607566
- Acronym / sponsor ID
- R21AT008830
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Yoga, Walking, Stress, exercise, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- University of Massachusetts, Lowell, Rhode Island Hospital
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iyengar Yoga | Experimental | Behavioral: YogaIyengar Yoga Intervention twice weekly for 60 minutes for 12 weeks. |
| Standard Exercise Program | Active comparator | Behavioral: Standard Exercise Programprofessionally supervised program of aerobic exercise including use of an indoor walking track, treadmills, stationary bicycles and elliptical machines, held for 60 minutes twice weekly for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes for more than 6 months
- HbA1c > 6.5
- Body Mass Index < 42
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga | Behavioural | Iyengar Yoga |
| Standard Exercise Programtwice weekly aerobic exercise program, 60 minutes for 12 weeks | Behavioural | Standard Exercise Program |
Primary outcome
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
4 secondary outcomes
Changes in diabetes-related distress as measured by Diabetes Related Distress Survey
Time frame: Baseline to Week 12
Changes in Salivary Cortisol (ug/dL) between baseline and week 12
Time frame: Baseline to Week 12
HbA1c
Time frame: 6 months
Diabetes Self-Care
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Background: PubMed 30130144Thind 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.
- Results publication: PubMed 30712714Thind 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.
- Results publication: PubMed 30670230Bock 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.
- Results publication: PubMed 28882745Thind 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Bock, PhD principal investigator
The Miriam Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Standard Exercise Program in people with Diabetes Mellitus, Type 2, run by The Miriam Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability as measured by session attendance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02607566, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.