Clinical trial: Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I (NCT01452893)

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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months.  She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs.  Physical examination shows a generalized increase in pigmentation of the skin.  Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease)

Patient description (patient's own words): I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy.

Does the patient match the trial criteria? Entailment