Effect of Acute Psychological Stress on Glucose Concentrations in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Trier Social Stress Test (TSST)
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Type 2 Diabetes focused on measuring glucose control in acute stress
Eligibility Criteria
Inclusion Criteria:
- type 2 diabetes
- oral antidiabetic treatment and/or long acting insulin overnight
Exclusion Criteria:
- full insulin regimen
- pregnancy or breast-feeding
- instable coronary heart disease
- poor visibility
- proliferative diabetic retinopathy
- uncontrolled arterial hypertension
Sites / Locations
- University Hospital of Zurich, Division of Endocrinology and Diabetes
Outcomes
Primary Outcome Measures
change of glucose measurements after stress test in the fasting and fed state
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00442884
Brief Title
Effect of Acute Psychological Stress on Glucose Concentrations in Patients With Type 2 Diabetes
Official Title
Effect of Acute Psychological Stress on Glucose Concentrations in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to evaluate the effects of acute psychological stress on blood glucose levels. We will study one group of patients in the fasting state on a control day and a stress test day, another group will undergo the same protocol in the postprandial state.
Detailed Description
Patients with type 2 diabetes often complain about changing blood glucose levels in times of emotional or mental stress, most subject's self-reporting higher blood glucose measurements in stressful conditions. To daily distress in diabetes additional emotional or mental stress can add a further momentum to destabilize glucose levels due to the adrenocortical response with enhancing insulin resistance and decreasing the endogenous insulin secretion. Another physiological link between stress and diabetes might be a higher sensitivity of the hypothalamo-pituitary-adrenal axis, leading to antagonizing effects on insulin actions. A study in type 2 diabetes demonstrated that stressors can destabilize blood glucose levels. Stress levels in diabetes have been shown to have a relationship to diabetic complications. Previous studies of psychological stress in type 1 diabetes have shown no effect of elevated catecholamine levels after short-lived psychological stimuli on glucose levels, but a significantly delayed decrease of glucose concentrations after an acute psychological stress in the postprandial state in association with elevated cortisol levels, showing no change of glucose concentration in the fasting state. This was in contrast to previous data in healthy subjects, showing that low glucose levels before a psychological stress prevented the stress-induced activation of the hypothalamus pituitary adrenal axis, but postprandial higher blood glucose levels induced a large cortisol response. These findings of a different cortisol responses in the fasting or fed status in healthy or absolute insulin deficient subjects could also be relevant for glucose metabolism in subjects with type 2 diabetes.
The effect of an acute psychological stress on glucose concentration may critically depend on whether stress is applied in the fasting or fed state. A different metabolic response to stress depending on food intake could explain different findings in other clinical trials and contribute to understanding glucose responses to stress. The aim of our study was thus to test whether the effect of acute psychological stress on glucose concentrations is different in the fasting compared to the fed state in type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
glucose control in acute stress
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Trier Social Stress Test (TSST)
Primary Outcome Measure Information:
Title
change of glucose measurements after stress test in the fasting and fed state
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 2 diabetes
oral antidiabetic treatment and/or long acting insulin overnight
Exclusion Criteria:
full insulin regimen
pregnancy or breast-feeding
instable coronary heart disease
poor visibility
proliferative diabetic retinopathy
uncontrolled arterial hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Wiesli, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Zurich, Division of Endocrinology and Diabetes
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21883440
Citation
Faulenbach M, Uthoff H, Schwegler K, Spinas GA, Schmid C, Wiesli P. Effect of psychological stress on glucose control in patients with Type 2 diabetes. Diabet Med. 2012 Jan;29(1):128-31. doi: 10.1111/j.1464-5491.2011.03431.x.
Results Reference
derived
Learn more about this trial
Effect of Acute Psychological Stress on Glucose Concentrations in Patients With Type 2 Diabetes
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