Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Addison's Disease, Adrenal Insufficiency, Diabetes Mellitus Type I

Intervention / Treatment
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* Procedure: Spiroergometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control with normal adrenal function and normal glucose regulation Age ≥ 18 years Ability to comply with the study protocol Capability to perform spiroergometry Exclusion Criteria: Any contraindication for performing spiroergometry according to the guidelines of the German Cardiac Society: acute myocardial infarction instable angina pectoris symptomatic arrhythmia severe and symptomatic stenosis of the aortic valve decompensated heart failure acute pulmonary embolism Acute myocarditis Acute pericarditis Acute aortic dissection main coronary artery disease valvulopathies electrolyte disturbance arterial hypertension (systolic blood pressure > 200 mm Hg, diastolic BP > 110 mm Hg) Tachyarrhythmia or Bradyarrhythmia Hypertrophic cardiomyopathy and other forms of obstructive heart disease second or third degree atrioventricular block Fever Diabetes mellitus Type 2 Diseases or medication influencing the endogenous levels of plasma catecholamines(e. g. pheochromocytoma, paraganglioma, antidepressants, levodopa) Glucocorticoid-pharmacotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type I diabetes<br>Adult patients with diabetes mellitus type I but normal adrenal function | Procedure: Spiroergometry<br>* 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).<br>|
| Addison's disease<br>Adult patients with Addison's disease | Procedure: Spiroergometry<br>* 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).<br>|
| Type I diabetes and Addison's disease<br>Patients suffering from both, diabetes mellitus type I and Addison's disease | Procedure: Spiroergometry<br>* 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).<br>|
| healthy controls<br>healthy controls with normal adrenal function and normal glucose regulation | Procedure: Spiroergometry<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |