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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type I diabetes | Adult patients with diabetes mellitus type I but normal adrenal function |
| |
| Addison's disease | Adult patients with Addison's disease |
| |
| Type I diabetes and Addison's disease | Patients suffering from both, diabetes mellitus type I and Addison's disease |
| |
| healthy controls | healthy controls with normal adrenal function and normal glucose regulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiroergometry | Procedure | At visit 1 determination of the individual VO2max (maximal oxygen uptake) by spiroergometry after first testing of cognitive function. At visit 2: Spiroergometry with 3 min warm up followed by 5 min 50% VO2max and 15 min at the individual respiratory compensation point (RCP). |
| Measure | Description | Time Frame |
|---|---|---|
| difference in cognitive function before and after physical stress | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| differences in counterregulatory hormonal response to physical stress | blood samples for determination of blood glucose, catecholamines and other counterregulatory hormones (cortisol, growth hormone) are collected before, during and after physical activity. | at visit 2, blood sampling over 180 min starting 10 min before spiroergometry |
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Inclusion Criteria:
Exclusion Criteria:
Any contraindication for performing spiroergometry according to the guidelines of the German Cardiac Society:
Fever
Diabetes mellitus Type 2
Diseases or medication influencing the endogenous levels of plasma catecholamines(e. g. pheochromocytoma, paraganglioma, antidepressants, levodopa)
Glucocorticoid-pharmacotherapy
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Four groups:
Patients with Addison's disease alone patients with diabetes mellitus type I alone patients with both, Addison's disease and Diabetes mellitus type I healthy controls
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Allolio, MD | University of Wuerzburg | Study Chair |
| Stefanie Hahner, MD | University of Wuerzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg | Würzburg | 97080 | Germany |
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| ID | Term |
|---|---|
| D000224 | Addison Disease |
| D000309 | Adrenal Insufficiency |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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blood samples for hormonal analysis
|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |