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

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

Study Overview

• Status: Completed
• Conditions: Adrenal Insufficiency; Addison's Disease; Diabetes Mellitus Type I
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Germany
  • Wuerzburg, Germany, 97080
    • Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in cognitive function before and after physical stress	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.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
differences in counterregulatory hormonal response to physical stress	blood samples for determination of blood glucose, catecholamines and other counterregulatory hormones (cortisol, growth hormone) are collected before, during and after physical activity.	at visit 2, blood sampling over 180 min starting 10 min before spiroergometry

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: October 12, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Estimate): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 3, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Adrenal Gland Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Adrenal Insufficiency; Addison Disease
• Other Study ID Numbers: CANDI-1