The Circadian Rhythm in CusHing SyndrOme in Active Phase and dUring RemiSsion (TheHOURS) (TheHOURS)
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|ClinicalTrials.gov Identifier: NCT03343470|
Recruitment Status : Unknown
Verified January 2018 by Andrea M. Isidori, University of Roma La Sapienza.
Recruitment status was: Recruiting
First Posted : November 17, 2017
Last Update Posted : January 29, 2018
|Condition or disease|
Cushing Syndrome is a severe condition caused by prolonged exposure to high levels of glucocorticoids.
This is a disease with high morbidity and mortality due to metabolic, cardiovascular, coagulative, psychiatric complications of hypercortisolism.
The loss of circadian secretion of cortisol is one of the most sensitive and specific diagnostic features of Cushing's Syndrome that normalizes during remission. The evaluation of the circadian rhythm of cortisol is one of the diagnostic tests recommended by the guidelines to evaluate the state of the disease's activity.
Studies in literature have shown several correlations between states of hypercortisolism and circadian secretion of melatonin, displaying reduced melatonin secretion throughout the day and the suppression of circadian rhythm of cortisol. However, the dynamics of the normalization of melatonin circadian rhythm during remission from Cushing syndrome are unclear.
Therefore, the aim of our study is to evaluate the changes in circadian secretion of melatonin in Cushing's syndrome during active disease and during remission (3 and 6 months), according to the rational scientific influence of endogenous hypercortisolism on the function of the pineal gland. In addition, the changes in circadian secretion of cortisol, of mononuclear cells of the blood (PBMC) and of anthropometric-metabolic parameters, will be analyzed.
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||The Observational Prospective Multicentric Study on Melatonin and Cortisol Circadian Rhythm in CusHing SyndrOme Patients in Active Phase and dUring RemiSsion.|
|Actual Study Start Date :||November 8, 2017|
|Estimated Primary Completion Date :||November 15, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Cushing Syndrome (active phase)
Patients displaying biochemical and clinical features of active Cushing's syndrome
Cushing Syndrome (during remission)
Patients at 3-6 months from remission with cortisol levels in the normal range
- change from baseline in measurement of melatonin secretion at 3 and 6 months [ Time Frame: 0, +3 months, +6 months ]single outcome measurement of melatonin secretion
- Evaluation of immunological profile at baseline, 3 and 6 months [ Time Frame: 0, +3 months, +6 months ]composite outcome measure consisting of simultaneous measurement of: PBMC profiling with flow cytometry, Full count blood cell
- Evaluation of cortisol circadian rhythm [ Time Frame: 0, +3 months, +6 months ]single outcome measure of circadian cortisol secretion
- Change from baseline in measurement of anthropometric-metabolic parameters at 3 and 6 months [ Time Frame: 0, +3 months, +6 months ]composite outcome measure consisting of simultaneous measurement of:body weight (kg), waist circumference (cm), blood pressure and pulse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343470
|Contact: Andrea M Isidori, MD, PhDemail@example.com|
|Department of Experimental Medicine||Recruiting|
|Rome, Italy, 00161|
|Contact: Andrea M Isidori, MD, PhD +390649970540 firstname.lastname@example.org|
|Principal Investigator:||Andrea M Isidori, MD, PhD||Dept. Experimental Medicine|