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Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I (CANDI)

U

University of Wuerzburg

Status

Completed

Conditions

Adrenal Insufficiency
Addison's Disease
Diabetes Mellitus Type I

Treatments

Procedure: Spiroergometry

Study type

Observational

Funder types

Other

Identifiers

NCT01452893
CANDI-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

40 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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