Cushing Syndrome
Conditions
Keywords
Cushing Syndrome, Adrenal Insufficiency, Peripheral blood mononuclear cells, Melatonin, Cortisol, Immunological profile, Cushing Disease
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Federico II University
University of Palermo
University of Florence
Ospedali Riuniti Ancona
University of Padova
University of Roma La Sapienza
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Cushing Syndrome during active phase
Exclusion criteria
* Malignancy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in measurement of melatonin secretion at 3 and 6 months | 0, +3 months, +6 months | single outcome measurement of melatonin secretion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of immunological profile at baseline, 3 and 6 months | 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 | 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 | 0, +3 months, +6 months | composite outcome measure consisting of simultaneous measurement of:body weight (kg), waist circumference (cm), blood pressure and pulse |
Countries
Italy
Contacts
Primary ContactAndrea M Isidori, MD, PhD
Outcome results
None listed