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CANDI: Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

Sponsor
University of Wuerzburg (Other)
Overall Status
Completed
CT.gov ID
NCT01452893
Collaborator
(none)
40
Enrollment
1
Location
33.1
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Spiroergometry

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 Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Type I diabetes

Adult patients with diabetes mellitus type I but normal adrenal function

Procedure: 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).
Addison's disease

Adult patients with Addison's disease

Procedure: 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).
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 (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

Procedure: 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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

  1. pheochromocytoma, paraganglioma, antidepressants, levodopa)
  • Glucocorticoid-pharmacotherapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg Wuerzburg Germany 97080

Sponsors and Collaborators

  • University of Wuerzburg

Investigators

  • Study Chair: Bruno Allolio, MD, University of Wuerzburg
  • Principal Investigator: Stefanie Hahner, MD, University of Wuerzburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bruno Allolio, professor of medicine, head of the department of endocrinology and diabetology, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT01452893
Other Study ID Numbers:
  • CANDI-1
First Posted:
Oct 17, 2011
Last Update Posted:
Jan 6, 2014
Last Verified:
Jan 1, 2014
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Adrenal Insufficiency
Addison Disease

Study Results

No Results Posted as of Jan 6, 2014