Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

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.

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Key information

Conditions

Addison's Disease Addison Disease Adrenal Gland Diseases Adrenal Insufficiency Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus Type I Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg

Würzburg, 97080, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spiroergometry

Procedure

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).

Primary outcomes

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)

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 outcomes

differences in counterregulatory hormonal response to physical stress

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wuerzburg

Other

Registry information

Official study title

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

Acronym: CANDI

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Oct 17, 2011
Registry last updated: Jan 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed