Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

NCT01452893 | Completed

• 1 other identifier: CANDI-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• differences in counterregulatory hormonal response to physical stress

  at visit 2, blood sampling over 180 min starting 10 min before spiroergometry

Study Arms (4)

Type I diabetes

Adult patients with diabetes mellitus type I but normal adrenal function

Procedure: Spiroergometry

Addison's disease

Adult patients with Addison's disease

Procedure: Spiroergometry

Type I diabetes and Addison's disease

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

Procedure: Spiroergometry

healthy controls

healthy controls with normal adrenal function and normal glucose regulation

Procedure: Spiroergometry

Interventions

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).

Addison's disease; Type I diabetes; Type I diabetes and Addison's disease; healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wuerzburg: lead

Study Sites (1)

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

Würzburg, 97080, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for hormonal analysis

MeSH Terms

Conditions

Addison Disease; Adrenal Insufficiency; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bruno Allolio, MD

  University of Wuerzburg

  STUDY CHAIR

• Stefanie Hahner, MD

  University of Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine, head of the department of endocrinology and diabetology

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 17, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2013
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

DE (1)