Cushing Syndrome Clinical Trial
Official title:
Effects of Liquorice on Salivary Cortisol and Cortisone
Salivary cortisol is used as a diagnostic analysis in the investigation of suspected Cushings' syndrome. This study evaluates if liqourice intake increases salivary cortisol in healthy individuals. Late night salivary cortisol and cortisone is analysed before, during and after 7 days of liqourice intake in three different doses.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Men and women 18-65 years. Exclusion Criteria: - Known pituitary or adrenal disease - Medication with glucocorticoids (incl. inhalation, nasal, dermal) - Known hypertension or blood pressure >140/90 at screening - tobacco use - Subjective problems in oral mucosa or saliva - Abnormal diurnal rhythm (awake 03:00 - 05:30) - Difficulties taking liqourice for 3 weeks or refraining from liqourice during 4 weeks |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Department of Public Health and Clinical, Umeå University | Umeå |
| Lead Sponsor | Collaborator |
|---|---|
| Umeå University |
Sweden,
Nieman LK. Cushing's syndrome: update on signs, symptoms and biochemical screening. Eur J Endocrinol. 2015 Oct;173(4):M33-8. doi: 10.1530/EJE-15-0464. Epub 2015 Jul 8. Review. — View Citation
Perogamvros I, Owen LJ, Newell-Price J, Ray DW, Trainer PJ, Keevil BG. Simultaneous measurement of cortisol and cortisone in human saliva using liquid chromatography-tandem mass spectrometry: application in basal and stimulated conditions. J Chromatogr B — View Citation
Perogamvros I, Ray DW, Trainer PJ. Regulation of cortisol bioavailability--effects on hormone measurement and action. Nat Rev Endocrinol. 2012 Dec;8(12):717-27. doi: 10.1038/nrendo.2012.134. Epub 2012 Aug 14. Review. — View Citation
Whorwood CB, Sheppard MC, Stewart PM. Licorice inhibits 11 beta-hydroxysteroid dehydrogenase messenger ribonucleic acid levels and potentiates glucocorticoid hormone action. Endocrinology. 1993 Jun;132(6):2287-92. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Late night salivary cortisol | Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake). | day 1 to day 7 during liqourice intake | |
| Primary | Time to normalization of late night salivary cortisol | Time from liqourice intake is stopped until significant increase of late night salivary cortisol from baseline (i.e. assuming outcome 1 is significant increase) is no longer significant. | 1-28 days efter liqourice intake is stopped | |
| Secondary | Morning salivary cortisol | Significantly increased salivary cortisol 08:00 AM compared to baseline (i.e. before start of liqourice intake). | day 1-2 during liqourice intake | |
| Secondary | Late night salivary cortisol/cortisone ratio | Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake). | day 1 to day 7 during liqourice intake | |
| Secondary | Time to normalization of late night salivary cortisol/cortisone ratio | Time from liqourice intake is stopped until significant increase of late night salivary cortisol from baseline (i.e. assuming outcome 1 is significant increase) is no longer significant. | 1-28 days efter liqourice intake is stopped |
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