Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I (CANDI)

University of Wuerzburg

Status

Completed

Conditions

Adrenal Insufficiency

Addison's Disease

Diabetes Mellitus Type I

Treatments

Procedure: Spiroergometry

Study type

Observational

Funder types

Other

Identifiers

NCT01452893

CANDI-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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