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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00442884
First received: March 2, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Trier Social Stress Test (TSST)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Effect of Acute Psychological Stress on Glucose Concentrations in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • change of glucose measurements after stress test in the fasting and fed state

Estimated Enrollment: 30
Study Start Date: February 2006
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442884

Locations
Switzerland
University Hospital of Zurich, Division of Endocrinology and Diabetes
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Peter Wiesli, MD University of Zurich
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00442884     History of Changes
Other Study ID Numbers: EK-1261
Study First Received: March 2, 2007
Last Updated: March 2, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
glucose control in acute stress

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Stress, Psychological
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 26, 2014