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

This study is currently recruiting participants.
Verified October 2011 by University of Wuerzburg
Sponsor:
Information provided by (Responsible Party):
Bruno Allolio, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT01452893
First received: September 29, 2011
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Addison's Disease
Adrenal Insufficiency
Diabetes Mellitus Type I
 Procedure: Spiroergometry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 strenous activity at a bicycle ergometer.


Secondary Outcome Measures:
  • differences in counterregulatory hormonal response to physical stress [ Time Frame: at visit 2, blood sampling over 180 min starting 10 min before spiroergometry ] [ Designated as safety issue: No ]
    blood samples for determination of blood glucose, catecholamines and other counterregulatory hormones (cortisol, growth hormone) are collected before, during and after physical activity.


Biospecimen Retention:   Samples Without DNA

blood samples for hormonal analysis


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type I diabetes
Adult patients with diabetes mellitus type I but normal adrenal function
 Procedure: Spiroergometry

At visit 1 determination of the individual VO2max 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).

Other Name: not available
Addison's disease
Adult patients with Addison's disease
 Procedure: Spiroergometry

At visit 1 determination of the individual VO2max 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).

Other Name: not available
Type I diabetes and Addison's disease
Patients suffering from both, diabetes mellitus type I and Addison's disease
 Procedure: Spiroergometry

At visit 1 determination of the individual VO2max 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).

Other Name: not available
healthy controls
healthy controls with normal adrenal function and normal glucose regulation
 Procedure: Spiroergometry

At visit 1 determination of the individual VO2max 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).

Other Name: not available

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Four groups:

Patients with Addison's disease alone patients with diabetes mellitus type I alone patients with both, Addison's disease and Diabetes mellitus type I healthy controls

Criteria

Inclusion Criteria:

  • Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control with normal adrenal function and normal glucosse 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:

    • akute myokardial 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452893

Contacts
Contact: Stefanie Hahner, MD +49 931 201 1 hahner_s@medizin.uni-wuerzburg.de
Contact: Bruno Allolio, MD +49 931 201 1 allolio_b@medizin.uni-wuerzburg.de

Locations
Germany
Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Stefanie Hahner, MD     +49 931 201 1     hahner_s@medizin.uni-wuerzburg.de    
Sponsors and Collaborators
University of Wuerzburg
Investigators
Study Chair: Bruno Allolio, MD University of Wuerzburg
Principal Investigator: Stefanie Hahner, MD University of Wuerzburg
  More Information

No publications provided

Responsible Party: Bruno Allolio, professor of medicine, head of the department of endocrinology and diabetology, University of Wuerzburg
ClinicalTrials.gov Identifier: NCT01452893     History of Changes
Other Study ID Numbers: CANDI-1
Study First Received: September 29, 2011
Last Updated: October 12, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Diabetes Mellitus
Diabetes Mellitus, Type 1
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013