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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2015-11-12', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability as measured by session attendance', 'timeFrame': '12 weeks', 'description': 'Number of sessions attended'}, {'measure': 'Feasibility as measured by study completion', 'timeFrame': '6 months', 'description': 'Percent of enrolled subjects completing all assessments'}], 'secondaryOutcomes': [{'measure': 'Changes in diabetes-related distress as measured by Diabetes Related Distress Survey', 'timeFrame': 'Baseline to Week 12', 'description': 'Percent change in score on the Diabetes Related Distress Survey (Polonsky et al., 1995)'}, {'measure': 'Changes in Salivary Cortisol (ug/dL) between baseline and week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Saliva samples collected at baseline and week 12 will be assayed for cortisol levels (ug/dL)'}, {'measure': 'HbA1c', 'timeFrame': '6 months', 'description': 'HbA1c levels from blood draws'}, {'measure': 'Diabetes Self-Care', 'timeFrame': '12 weeks', 'description': 'Surveys of diabetes related self care activities'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Yoga', 'Walking', 'Stress', 'exercise', 'glycemic control'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '30130144', 'type': 'BACKGROUND', '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.'}, {'pmid': '30712714', 'type': 'RESULT', '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.'}, {'pmid': '30670230', 'type': 'RESULT', '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.'}, {'pmid': '28882745', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes for more than 6 months\n* HbA1c \\> 6.5\n* Body Mass Index \\< 42\n\nExclusion Criteria:\n\n* Serious co-morbid condition (e.g. uncontrolled hypertension, glaucoma, heart failure)\n* Complications of diabetes (e.g. diabetic retinopathy, neuropathy, nephropathy)\n* Serious psychiatric disorder (e.g. psychosis, major depression, panic attacks, suicidality, or substance dependence)\n* Body Mass Index of 42 or greater\n* Pregnancy or planned pregnancy'}, 'identificationModule': {'nctId': 'NCT02607566', 'briefTitle': 'Yoga as a Complementary Therapy for Adults With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'Yoga as a Complementary Therapy for Type 2 Diabetes: An Initial Investigation', 'orgStudyIdInfo': {'id': 'R21AT008830', 'link': 'https://reporter.nih.gov/quickSearch/R21AT008830', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iyengar Yoga', 'description': 'Iyengar Yoga Intervention twice weekly for 60 minutes for 12 weeks.', 'interventionNames': ['Behavioral: Yoga']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Exercise Program', 'description': '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', 'interventionNames': ['Behavioral: Standard Exercise Program']}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Iyengar Yoga']}, {'name': 'Standard Exercise Program', 'type': 'BEHAVIORAL', 'description': 'twice weekly aerobic exercise program, 60 minutes for 12 weeks', 'armGroupLabels': ['Standard Exercise Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital- CORO building', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Beth Bock, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Miriam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Massachusetts, Lowell', 'class': 'OTHER'}, {'name': 'Rhode Island Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}