Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

University of Wuerzburg40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Addison's Disease Adrenal Insufficiency Diabetes Mellitus Type I

Interventions

SpiroergometryPROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg

Würzburg, Germany

Outcomes

Primary Outcomes

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.

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)

Secondary Outcomes

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.

Time frame: at visit 2, blood sampling over 180 min starting 10 min before spiroergometry

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.