Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT01452893
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01452893
Study Brief:
Protocol Section:
NCT01452893