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

U

University of Roma La Sapienza

Status

Enrolling

Conditions

Cushing Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT03343470
Adrenal_2

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

15 participants in 2 patient groups

Cushing Syndrome (active phase)
Description:
Patients displaying biochemical and clinical features of active Cushing's syndrome
Cushing Syndrome (during remission)
Description:
Patients at 3-6 months from remission with cortisol levels in the normal range

Trial contacts and locations

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Central trial contact

Andrea M Isidori, MD, PhD

Data sourced from clinicaltrials.gov

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