Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

NCT ID: NCT01452893

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-12-31

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.

Conditions

Addison's Disease; Adrenal Insufficiency; Diabetes Mellitus Type I

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Type I diabetes

Adult patients with diabetes mellitus type I but normal adrenal function

Spiroergometry

Intervention Type: 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).

Addison's disease

Adult patients with Addison's disease

Spiroergometry

Intervention Type: 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).

Type I diabetes and Addison's disease

Patients suffering from both, diabetes mellitus type I and Addison's disease

Spiroergometry

Intervention Type: 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).

healthy controls

healthy controls with normal adrenal function and normal glucose regulation

Spiroergometry

Intervention Type: 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).

Interventions

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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wuerzburg

OTHER

Sponsor Role: lead

Responsible Party

Bruno Allolio

professor of medicine, head of the department of endocrinology and diabetology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno Allolio, MD

Role: STUDY_CHAIR

University of Wuerzburg

Stefanie Hahner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wuerzburg

Locations

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

Würzburg, , Germany

Countries

Germany

Other Identifiers

CANDI-1

Identifier Type: -

Identifier Source: org_study_id