Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01452893
• Date of registration: 29/09/2011
• Prospective Registration: No
• Primary sponsor: University of Wuerzburg
• Public title: Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I CANDI
• Scientific title: Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I
• Date of first enrolment: March 2011
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01452893
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Stefanie Hahner, MD
• Affiliation: University of Wuerzburg

• Name: Bruno Allolio, MD
• Affiliation: University of Wuerzburg

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Addison's Disease

Diabetes Mellitus Type I

Adrenal Insufficiency

Intervention(s)

Procedure: Spiroergometry

Primary Outcome(s)

difference in cognitive function before and after physical stress [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 Outcome(s)

differences in counterregulatory hormonal response to physical stress [Time Frame: at visit 2, blood sampling over 180 min starting 10 min before spiroergometry]

Secondary ID(s)

CANDI-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors