The Circadian Rhythm in CusHing SyndrOme in Active Phase and dUring RemiSsion (TheHOURS)

Recruiting

• Conditions: Cushing Syndrome

• Registration Number: NCT03343470
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2017-11-08
• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-17
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-23
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Department of Experimental Medicine; 🇮🇹 Rome, Italy