University of North Carolina
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT01805245
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.
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Notify Me30 year and older
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
diet, exercise, oral medications, insulin or other injectable diabetic medication
Exclusion criteria
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
Time frame: 0,8,24 weeks
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.
Time frame: 0,8,24 weeks
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
Time frame: 0, 8,24 weeks
This measure is a patient reported outcome assessing general quality of life and will be assessed using the standardized SF36 tool.
Time frame: 0,8,24 weeks
This measure is a patient reported outcome assessing general quality of life and will be assessed using the standardized SF36 tool.
Time frame: 0,8,24 weeks
Mean systolic blood pressure over 24 hours.
Time frame: 0,8,24 weeks
Mean diastolic blood pressure over 24 hours
Time frame: 0,8,24 weeks
For those participants that are not using insulin, we will assess the degree of insulin resistance using the HOMA-IR, which is derived from the fasting insulin and fasting glucose.
Time frame: 0,8,24 weeks
Using the Beck Depression Inventory we will assess symptoms of depression using this standardized patient reported outcome.
Time frame: 0,8,24 weeks
Using the State and Trait Anxiety Assessment we will measure "state" anxiety.
Time frame: 0,8,24 weeks
Using the State and Trait Anxiety Survey we will assess "trait" anxiety.
Time frame: 0,8,24 weeks
Using the Duke Social Support and Stress Scale we will assess the degree of social support participants report in their lives.
Time frame: 0,8,24 weeks
Using the Coping Orientation to Problems Experienced Scale, we will evaluate the various coping styles and how they may change over time.
Time frame: 0,8,24 weeks
Using the Perceived Stress Scale we will assess general life stressors.
Time frame: 0,8,24 weeks
Calculating the area under the curve for 24 hours we will assess cortisol secretion as a physiological assessment of stress
Time frame: 0,8,24 weeks
We will measure the cortisol awakening response using measures of cortisol prior to arising and 30 minutes after waking up.
Time frame: 0,8, 24 weeks
IL-6 is an assessment of systemic inflammation and will be measured in serum.
Time frame: 0,8,24 weeks
This patient reported measure assesses the frequency which participants engage in self-care activities that are critical for DM self-management.
Time frame: 0,8,24 weeks
Average cgm glucose over 24 hours
Time frame: 0,8,24 weeks
Average night time glucose from 10pm-6am using continuous glucose monitoring values
Time frame: 0,8,24 weeks
Average day time glucose from 6am-10pm using continuous glucose monitoring values
Time frame: Week 0
Standardized assessment of dietary patterns
Time frame: 0,8,24 weeks
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm
Time frame: 0,8,24 weeks
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm
Time frame: 0,8,24 weeks
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.
Time frame: 0,8,24 weeks
The average diastolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.
Time frame: 0,8,24 weeks
To assess mindfulness we will utilize the Five Facet Mindfulness Questionnaire.
University of North Carolina, Chapel Hill
Other
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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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