Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

Completed

• Conditions: Adrenal Insufficiency; Addison's Disease; Diabetes Mellitus Type I
• Interventions: Procedure: Spiroergometry

• Registration Number: NCT01452893
• Lead Sponsor: University of Wuerzburg

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-17
• Primary Completion: 2012-05
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy controls	Spiroergometry	healthy controls with normal adrenal function and normal glucose regulation
Type I diabetes	Spiroergometry	Adult patients with diabetes mellitus type I but normal adrenal function
Addison's disease	Spiroergometry	Adult patients with Addison's disease
Type I diabetes and Addison's disease	Spiroergometry	Patients suffering from both, diabetes mellitus type I and Addison's disease

Primary Outcome Measures

Name	Time	Method
difference in cognitive function before and after physical stress	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)	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.

Secondary Outcome Measures

Name	Time	Method
differences in counterregulatory hormonal response to physical stress	at visit 2, blood sampling over 180 min starting 10 min before spiroergometry	blood samples for determination of blood glucose, catecholamines and other counterregulatory hormones (cortisol, growth hormone) are collected before, during and after physical activity.

Trial Locations

Locations (1)

Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Germany