Clinical trial NCT01452893: Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I
Official title: Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Addison's Disease
Adrenal Insufficiency
Diabetes Mellitus Type I
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Four groups:

Patients with Addison's disease alone patients with diabetes mellitus type I alone patients with both, Addison's disease and Diabetes mellitus type I healthy controls

Brief summary: 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: 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.

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

Primary outcomes:
measure: difference in cognitive function before and after physical stress
timeFrame: 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:
measure: differences in counterregulatory hormonal response to physical stress
timeFrame: at visit 2, blood sampling over 180 min starting 10 min before spiroergometry
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg
Study officials:
affiliation: University of Wuerzburg
name: Bruno Allolio, MD
role: STUDY_CHAIR
affiliation: University of Wuerzburg
name: Stefanie Hahner, MD
role: PRINCIPAL_INVESTIGATOR
References: