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| Name | Class |
|---|---|
| Federico II University | OTHER |
| University of Palermo | OTHER |
| University of Florence | OTHER |
| Ospedali Riuniti Ancona |
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This is an observational, open, prospective multi-centre study designed to evaluate melatonin and cortisol circadian rhythm, immunological profile and anthropometric parameters in Cushing Syndrome patients during active Remission state.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in measurement of melatonin secretion at 3 and 6 months | single outcome measurement of melatonin secretion | 0, +3 months, +6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of immunological profile at baseline, 3 and 6 months | composite outcome measure consisting of simultaneous measurement of: PBMC profiling with flow cytometry, Full count blood cell | 0, +3 months, +6 months |
| Evaluation of cortisol circadian rhythm |
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Inclusion Criteria:
Exclusion Criteria:
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Cushing Syndrome patients in active phase and during remission at 3 and 6 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea M Isidori, MD, PhD | Contact | +390649970540 | andrea.isidori@uniroma1.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrea M Isidori, MD, PhD | Dept. Experimental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Experimental Medicine | Recruiting | Rome | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18509277 | Result | 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. | |
| 26067718 | Result | 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. |
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| ID | Term |
|---|---|
| D003480 | Cushing Syndrome |
| D000309 | Adrenal Insufficiency |
| D047748 | Pituitary ACTH Hypersecretion |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D006964 | Hyperpituitarism |
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| OTHER |
| University of Padova | OTHER |
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single outcome measure of circadian cortisol secretion |
| 0, +3 months, +6 months |
| Change from baseline in measurement of anthropometric-metabolic parameters at 3 and 6 months | composite outcome measure consisting of simultaneous measurement of:body weight (kg), waist circumference (cm), blood pressure and pulse | 0, +3 months, +6 months |
| 2268888 | Result | 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. |
| 6684004 | Result | 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. |
| 1478121 | Result | 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. |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |