Clinical trial NCT01805245: Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
Official title: Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Distress
Type 2 Diabetes
Stress
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age \> 30 years
2. Male or female
3. Duration of diabetes 1-15 years from time of initial diagnosis
4. Diagnosis of T2DM made/confirmed by physician
5. Completed diabetes education in the past
6. Most recent HgA1c \>7%; measurement must be within the past 6 months either in physicians office or at the Thriving with Diabetes Boot Camp Class
7. Treatment for diabetes must include any or all of the following modalities:

   diet, exercise, oral medications, insulin or other injectable diabetic medication
8. Score \> 30 on the Problem Area in Diabetes (PAID) Questionnaire
9. Able to use a glucometer for self-monitoring of blood glucose values
10. Most recent clinic blood pressure less than 180/95

Exclusion Criteria:

1. History of ketoacidosis
2. Age at diagnosis of T2DM \< 30 years
3. Score \>15 on the PHQ-9
4. Previous training in relaxation or meditation techniques
5. Current practice of yoga, tai chi or any other mind-body movement for \> 60 minutes per week
6. Current use of a psychoactive drug for less than 3 months or not yet on a stable dose
7. Inability to participate fully or behave appropriately in the group treatment setting, as observed by baseline acknowledgement of substance abuse, psychotic episode(s), psychiatric hospitalization or history of self- harm within the past 2 years, or current suicidal or homicidal ideation
8. Inability to complete standardized instruments because of a cognitive deficit or language barrier
9. Current use or use within the past 3 months of oral glucocorticoids, excluding intraocular, topical or inhaled preparations
10. History of inflammatory diseases including rheumatoid arthritis and inflammatory bowel disease
11. Use of immune modulating agents
12. Night shift work or other type of schedule in which sleep wake cycle is disrupted
13. Women who consume \> 7 alcoholic drinks per week and men who consume \> 14 drinks per week
14. Current use or history of daily tobacco use within the past 1 year
15. End stage renal failure on dialysis
16. Pregnancy or post partum \<3 months
17. Subjects with known secondary causes of hypertension including renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronemia
18. Non-dominant arm circumference \> 46cm
19. Unwilling to accept randomization

Primary outcomes:
measure: HgA1c
timeFrame: 0,8,24 weeks
measure: Diabetes Distress
timeFrame: 0,8,24 weeks
Secondary outcomes:
measure: SF36 Physical Health Score
timeFrame: 0, 8,24 weeks
measure: SF36 Mental Health Score
timeFrame: 0,8,24 weeks
measure: Mean 24 hour ambulatory systolic blood pressure
timeFrame: 0,8,24 weeks
measure: Mean 24 hour diastolic ambulatory blood pressure
timeFrame: 0,8,24 weeks
measure: HOMA-IR
timeFrame: 0,8,24 weeks
measure: Depression
timeFrame: 0,8,24 weeks
measure: State Anxiety
timeFrame: 0,8,24 weeks
measure: Trait Anxiety
timeFrame: 0,8,24 weeks
measure: Social Support
timeFrame: 0,8,24 weeks
measure: Coping Style
timeFrame: 0,8,24 weeks
measure: General Stress
timeFrame: 0,8,24 weeks
measure: Cortisol 24 hour area under the curve
timeFrame: 0,8,24 weeks
measure: Cortisol Awakening Response
timeFrame: 0,8,24 weeks
measure: IL-6
timeFrame: 0,8, 24 weeks
measure: Summary of Diabetes Self-Care Activities
timeFrame: 0,8,24 weeks
measure: Average 24 hour glucose by continuous glucose monitor (cgm)
timeFrame: 0,8,24 weeks
measure: Average night time glucose
timeFrame: 0,8,24 weeks
measure: Average day time glucose
timeFrame: 0,8,24 weeks
measure: Block Food Frequency Questionnaire
timeFrame: Week 0
measure: Mean Day Systolic Ambulatory Blood Pressure
timeFrame: 0,8,24 weeks
measure: Mean Day Diastolic Ambulatory Blood Pressure
timeFrame: 0,8,24 weeks
measure: Mean Night Systolic Ambulatory Blood Pressure
timeFrame: 0,8,24 weeks
measure: Mean Night Diastolic Ambulatory Blood Pressure
timeFrame: 0,8,24 weeks
Other outcomes:
measure: Mindfulness
timeFrame: 0,8,24 weeks
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Laura A Young, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: