Clinical Trial: Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I

Brief Summary: Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore, patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities. The study investigates the counter regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects.

Detailed Summary: As patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction and patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities this study investigates the counter-regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects. Patients will perform ergometer training with an individualized intensity and fulfill cognitive function testing (stroop test and fatigue inventories) before and after strenuous activity.
Sponsor: University of Wuerzburg

Current Primary Outcome: difference in cognitive function before and after physical stress [ Time Frame: testing is performed at first visit (baseline, duration 5 min) and second visit (at least 48 hours after visit1). The second test is performed 5 min after strenous activity of 23 min duration, test duration again 5 min) ]

study participants are tested with three standardized tests: stroop-task, symptom rating scale and a short term memory test. First testing is performed at visit 1 at rest, the second test at visit 2 after strenuous activity at a bicycle ergometer.


Original Primary Outcome: difference in cognitive function before and after physical stress [ Time Frame: testing is performed at first visit (baseline, duration 5 min) and second visit (at least 48 hours after visit1). The second test is performed 5 min after strenous activity of 23 min duration, test duration again 5 min) ]

study participants are tested with three standardized tests: stroop-task, symptom rating scale and a short term memory test. First testing is performed at visit 1 at rest, the second test at visit 2 after strenous activity at a bicycle ergometer.


Current Secondary Outcome: differences in counterregulatory hormonal response to physical stress [ Time Frame: at visit 2, blood sampling over 180 min starting 10 min before spiroergometry ]

blood samples for determination of blood glucose, catecholamines and other counterregulatory hormones (cortisol, growth hormone) are collected before, during and after physical activity.


Original Secondary Outcome: Same as current

Information By: University of Wuerzburg

Dates:
Date Received: September 29, 2011
Date Started: March 2011
Date Completion:
Last Updated: January 3, 2014
Last Verified: January 2014