NCT01805245|CompletedDMC
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Sponsor study identifier
interventional
78
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
December 2015
Actual (reported)The purpose of this study is to evaluate the impact of stress reduction on physiological and psychological variables in adults with Type 2 diabetes (T2DM) who have moderate to severe levels of diabetes-related emotional distress. Subjects will be randomized to one of two interventions. We will evaluate the impact of the interventions on glucose metabolism, blood pressure, diabetes-related distress and quality of life. Additionally, we will investigate the role of neuroendocrine dysfunction, systemic inflammation and diabetes self-care practices as mediators in the relationship between increased stress, adverse glucose metabolism and elevated blood pressure in those subjects with T2DM.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 15, 2012
Actual (reported)March 6, 2013
Actual (reported)November 2014
Actual (reported)December 2015
Actual (reported)HgA1c
We will assess change in glycemic control using the A1c. It will be measured at baseline, immediately following the 8 week intervention and at 24 weeks from baseline.
0,8,24 weeks
Diabetes Distress
The Problem Areas in Diabetes will be used to assess the change in diabetes emotional distress at baseline, immediately following the 8 week intervention and at 24 weeks from baseline
0,8,24 weeks
SF36 Physical Health Score
0, 8,24 weeks
SF36 Mental Health Score
0,8,24 weeks
Mean 24 hour ambulatory systolic blood pressure
0,8,24 weeks
Mean 24 hour diastolic ambulatory blood pressure
0,8,24 weeks
HOMA-IR
0,8,24 weeks
Mindfulness
0,8,24 weeks
Standard 8-week MBSR program; classes meet for 2.5 hours once weekly The health education control group meets at the same time and for the same amount of time
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Laura A Young, MD, PhD
University of North Carolina
78 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2012
First Posted
March 6, 2013
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes
Contact the study team to confirm eligibility.
Primary Completion
November 2014
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
April 19, 2017
Record last verified: 2017-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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