Addison Disease Clinical Trial
Official title:
Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal
Verified date | November 2013 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The conventional glucocorticoid replacement therapy in primary adrenal insufficiency- Addison's disease,renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Many patients take stress-doses that are extra doses of hydrocortisone or cortisone acetate before or during stressful physical or psychological events. However, the effect of such dosing has not been tested in scientific studies. In this double blind cross-over designed pilot trial we aim to test the effect of an extra dose of cortisol on physical activity and hormone levels.
Status | Unknown status |
Enrollment | 20 |
Est. completion date | March 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - patients with Addison`s disease Exclusion Criteria: - Type 1 diabetes - malignant disease - pregnant women - cardiac disease - lung disease - neuromuscular diseases - pharmacological treatment with glucocorticoids or drugs that interfere with cortisol metabolism (anti-epileptics, rifampicin, St Johns wart, oral estrogens, antidepressives). |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland Universitetessykehus, Department of Medicine | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway,
Bornstein SR, Breidert M, Ehrhart-Bornstein M, Kloos B, Scherbaum WA. Plasma catecholamines in patients with Addison's disease. Clin Endocrinol (Oxf). 1995 Feb;42(2):215-8. — View Citation
Ehrhart-Bornstein M, Bornstein SR. Cross-talk between adrenal medulla and adrenal cortex in stress. Ann N Y Acad Sci. 2008 Dec;1148:112-7. doi: 10.1196/annals.1410.053. Review. — View Citation
Green-Golan L, Yates C, Drinkard B, VanRyzin C, Eisenhofer G, Weise M, Merke DP. Patients with classic congenital adrenal hyperplasia have decreased epinephrine reserve and defective glycemic control during prolonged moderate-intensity exercise. J Clin Endocrinol Metab. 2007 Aug;92(8):3019-24. Epub 2007 May 29. — View Citation
Merke DP, Chrousos GP, Eisenhofer G, Weise M, Keil MF, Rogol AD, Van Wyk JJ, Bornstein SR. Adrenomedullary dysplasia and hypofunction in patients with classic 21-hydroxylase deficiency. N Engl J Med. 2000 Nov 9;343(19):1362-8. — View Citation
Neary N, Nieman L. Adrenal insufficiency: etiology, diagnosis and treatment. Curr Opin Endocrinol Diabetes Obes. 2010 Jun;17(3):217-23. doi: 10.1097/MED.0b013e328338f608. Review. — View Citation
Weise M, Drinkard B, Mehlinger SL, Holzer SM, Eisenhofer G, Charmandari E, Chrousos GP, Merke DP. Stress dose of hydrocortisone is not beneficial in patients with classic congenital adrenal hyperplasia undergoing short-term, high-intensity exercise. J Clin Endocrinol Metab. 2004 Aug;89(8):3679-84. — View Citation
Weise M, Mehlinger SL, Drinkard B, Rawson E, Charmandari E, Hiroi M, Eisenhofer G, Yanovski JA, Chrousos GP, Merke DP. Patients with classic congenital adrenal hyperplasia have decreased epinephrine reserve and defective glucose elevation in response to high-intensity exercise. J Clin Endocrinol Metab. 2004 Feb;89(2):591-7. — View Citation
Wurtman RJ, Axelrod J. Control of enzymatic synthesis of adrenaline in the adrenal medulla by adrenal cortical steroids. J Biol Chem. 1966 May 25;241(10):2301-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | O2 uptake | O2 uptake as V O2 90%. | 2 days | |
Secondary | post- exercise hypoglycemic events | blood glucose below = 3.1 mmol / L | 4 days | |
Secondary | glycemic variability | glycemic variability monitored by continuous glucose monitoring system | 6 days | |
Secondary | hormone response to exercise | Plasma norepinephrine, epinephrine, salivary alfa amylase Glucose, insulin, C-peptide, and lactate, glucagon Growth hormone and insulin like growth factor Free fatty acids |
2 days | |
Secondary | Blood pressure | vascular action | 2 days | |
Secondary | Subjective health status | Self administration by questionnaires | 2 days |
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