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Completed

NCT Number: NCT02607566

Yoga as a Complementary Therapy for Adults With Type 2 Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital, Providence, Rhode Island, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

Standard Exercise Program

Behavioral

twice weekly aerobic exercise program, 60 minutes for 12 weeks

Primary outcomes

  1. Acceptability as measured by session attendance

    Time frame: 12 weeks

    Number of sessions attended

  2. Feasibility as measured by study completion

    Time frame: 6 months

    Percent of enrolled subjects completing all assessments

Secondary outcomes

  1. Changes in diabetes-related distress as measured by Diabetes Related Distress Survey

    Time frame: Baseline to Week 12

    Percent change in score on the Diabetes Related Distress Survey (Polonsky et al., 1995)

  2. Changes in Salivary Cortisol (ug/dL) between baseline and week 12

    Time frame: Baseline to Week 12

    Saliva samples collected at baseline and week 12 will be assayed for cortisol levels (ug/dL)

  3. HbA1c

    Time frame: 6 months

    HbA1c levels from blood draws

  4. Diabetes Self-Care

    Time frame: 12 weeks

    Surveys of diabetes related self care activities

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • Rhode Island Hospital
  • University of Massachusetts, Lowell

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 18, 2015
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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