An observational study in Cushing Syndrome, sponsored by University of Roma La Sapienza. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-23.
Sponsored by University of Roma La Sapienza · Observational
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.
123 studies on the registry are indexed under Cushing Syndrome; 42 are open to participants now.
This study's planned enrollment of 15 is below the median of 121 across 63 observational studies indexed under Cushing Syndrome.
Browse Cushing Syndrome studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cushing Syndrome patients in active phase and during remission at 3 and 6 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients displaying biochemical and clinical features of active Cushing's syndrome
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
single outcome measurement of melatonin secretion
Time frame: 0, +3 months, +6 months
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
Time frame: 0, +3 months, +6 months
Evaluation of cortisol circadian rhythm
single outcome measure of circadian cortisol secretion
Time frame: 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
Time frame: 0, +3 months, +6 months
Started Nov 2017 (actual). Primary completion is estimated for Dec 2023, 73 months after the start.
Of 31 observational studies under Cushing Syndrome, half reached primary completion within 95 months of starting (the median), counting those still running; a quarter within 85. This study's planned 73 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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