Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343470
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : January 29, 2018
Sponsor:
Collaborators:
Federico II University
University of Palermo
University of Florence
Ospedali Riuniti Ancona
University of Padova
Information provided by (Responsible Party):
Andrea M. Isidori, 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.

Condition or disease
Cushing Syndrome

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Observational Prospective Multicentric Study on Melatonin and Cortisol Circadian Rhythm in CusHing SyndrOme Patients in Active Phase and dUring RemiSsion.
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : November 15, 2018
Estimated Study Completion Date : December 30, 2018


Group/Cohort
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



Primary Outcome Measures :
  1. change from baseline in measurement of melatonin secretion at 3 and 6 months [ Time Frame: 0, +3 months, +6 months ]
    single outcome measurement of melatonin secretion


Secondary Outcome Measures :
  1. Evaluation of immunological profile at baseline, 3 and 6 months [ Time Frame: 0, +3 months, +6 months ]
    composite outcome measure consisting of simultaneous measurement of: PBMC profiling with flow cytometry, Full count blood cell

  2. Evaluation of cortisol circadian rhythm [ Time Frame: 0, +3 months, +6 months ]
    single outcome measure of circadian cortisol secretion

  3. Change from baseline in measurement of anthropometric-metabolic parameters at 3 and 6 months [ Time Frame: 0, +3 months, +6 months ]
    composite outcome measure consisting of simultaneous measurement of:body weight (kg), waist circumference (cm), blood pressure and pulse



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cushing Syndrome patients in active phase and during remission at 3 and 6 months.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343470


Contacts
Layout table for location contacts
Contact: Andrea M Isidori, MD, PhD +390649970540 andrea.isidori@uniroma1.it

Locations
Layout table for location information
Italy
Department of Experimental Medicine Recruiting
Rome, Italy, 00161
Contact: Andrea M Isidori, MD, PhD    +390649970540    andrea.isidori@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Federico II University
University of Palermo
University of Florence
Ospedali Riuniti Ancona
University of Padova
Investigators
Layout table for investigator information
Principal Investigator: Andrea M Isidori, MD, PhD Dept. Experimental Medicine

Publications of Results:
Layout table for additonal information
Responsible Party: Andrea M. Isidori, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03343470     History of Changes
Other Study ID Numbers: Adrenal_2
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea M. Isidori, University of Roma La Sapienza:
Cushing Syndrome
Adrenal Insufficiency
Peripheral blood mononuclear cells
Melatonin
Cortisol
Immunological profile
Cushing Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Inflammatory Agents