drugset / Trial / NCT01847690
Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure
RandomizedCrossoverDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2013-06
- Primary completion
- 2014-01
- Completion
- 2014-03
Publications
- Background 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.
- Background 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. doi: 10.1210/jc.2003-032051.
- Background 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. No abstract available.
- Background 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.
- Background 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. doi: 10.1111/j.1365-2265.1995.tb01866.x.
- Background 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. doi: 10.1210/jc.2007-0493. Epub 2007 May 29.
- Background 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. doi: 10.1210/jc.2003-030634.
- Background 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. doi: 10.1056/NEJM200011093431903.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hydrocortisone | Other / unclassified | 10 mg | Oral |