The Circadian Rhythm in CusHing SyndrOme in Active Phase and dUring RemiSsion (TheHOURS)
NCT ID: NCT03343470
Last Updated: 2022-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
15 participants
OBSERVATIONAL
2017-11-08
2023-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cushing Syndrome (active phase)
Patients displaying biochemical and clinical features of active Cushing's syndrome
No interventions assigned to this group
Cushing Syndrome (during remission)
Patients at 3-6 months from remission with cortisol levels in the normal range
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Alcoholism or drug addiction
* Psychiatric disorders
* Clinical or laboratory signs of significant cardiovascular, hepatobiliary disease
* Clinically significant renal dysfunction
* Pregnancy
* Any medication with agents which could interfere with glucocorticoid kinetics and melatonin secretion
18 Years
80 Years
ALL
No
Sponsors
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Federico II University
OTHER
University of Palermo
OTHER
University of Florence
OTHER
Ospedali Riuniti Ancona
OTHER
University of Padova
OTHER
University of Roma La Sapienza
OTHER
Responsible Party
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Andrea M. Isidori
Assistant Professor
Principal Investigators
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Andrea M Isidori, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. Experimental Medicine
Locations
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Department of Experimental Medicine
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Tomova A, Kumanov P, Robeva R, Manchev S, Konakchieva R. Melatonin secretion and non-specific immune responses are differentially expressed in corticotropin-dependent and corticotropin-independent Cushing's syndrome. Med Sci Monit. 2008 Jun;14(6):CR327-332.
Pivonello R, De Leo M, Cozzolino A, Colao A. The Treatment of Cushing's Disease. Endocr Rev. 2015 Aug;36(4):385-486. doi: 10.1210/er.2013-1048. Epub 2015 Jun 11.
Piovesan A, Terzolo M, Borretta G, Torta M, Buniva T, Osella G, Paccotti P, Angeli A. Circadian profile of serum melatonin in Cushing's disease and acromegaly. Chronobiol Int. 1990;7(3):259-61. doi: 10.3109/07420529009056984.
Fevre-Montange M, Tourniaire J, Estour B, Bajard L. 24 hour melatonin secretory pattern in Cushing's syndrome. Clin Endocrinol (Oxf). 1983 Aug;19(2):175-81. doi: 10.1111/j.1365-2265.1983.tb02979.x.
Angeli A, Gatti G, Sartori ML, Masera RG. Chronobiological aspects of the neuroendocrine-immune network. Regulation of human natural killer (NK) cell activity as a model. Chronobiologia. 1992 Jul-Dec;19(3-4):93-110. No abstract available.
Other Identifiers
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Adrenal_2
Identifier Type: -
Identifier Source: org_study_id
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