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NCT01805245 · ClinicalTrials.gov registry record · NA
Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
NCT01805245: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT01805245 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 78 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01805245, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Mindfulness Based Stress Reduction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-12 |
| Phase | NA |
What the finished NCT01805245 record still lists
NCT01805245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Mindfulness Based Stress Reduction is the first listed.
NCT01805245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01805245 about?
NCT01805245 is a clinical study titled "Mindfulness: a Novel Approach for the Management of Diabetes-related Distress". 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 evalu...
What is the current status of trial NCT01805245?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2012-01. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01805245?
The interventions under investigation include: Mindfulness Based Stress Reduction (BEHAVIORAL).
Who is sponsoring clinical trial NCT01805245?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01805245's enrollment target sits among peer trials
78 1060th of 2000 higher than 939 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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