Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Acute Psychological Stress on Glucose Concentrations in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00442884
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : March 5, 2007
Sponsor:
Information provided by:
University of Zurich

Tracking Information
First Submitted Date  ICMJE March 2, 2007
First Posted Date  ICMJE March 5, 2007
Last Update Posted Date March 5, 2007
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2007)
change of glucose measurements after stress test in the fasting and fed state
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Acute Psychological Stress on Glucose Concentrations in Patients With Type 2 Diabetes
Official Title  ICMJE Effect of Acute Psychological Stress on Glucose Concentrations in Patients With Type 2 Diabetes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE Behavioral: Trier Social Stress Test (TSST)
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 2, 2007)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00442884
Other Study ID Numbers  ICMJE EK-1261
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Wiesli, MD University of Zurich
PRS Account University of Zurich
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP