Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

Adrenal Insufficiency Clinical Trial

— CANDI  

Official title:

Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452893
• Other study ID #: CANDI-1
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: January 3, 2014
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University of Wuerzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Addison Disease
• Addison's Disease
• Adrenal Insufficiency
• Diabetes Mellitus
• Diabetes Mellitus Type I
• Diabetes Mellitus, Type 1

Intervention

Procedure:
• Spiroergometry
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).

Locations

Country	Name	City	State
Germany	Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)	No
Secondary	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.	at visit 2, blood sampling over 180 min starting 10 min before spiroergometry	No