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

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ClinicalTrials.gov Identifier: NCT03343470
Recruitment Status : Unknown
Verified January 2018 by Andrea M. Isidori, University of Roma La Sapienza.
Recruitment status was:  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

Tracking Information
First Submitted Date November 10, 2017
First Posted Date November 17, 2017
Last Update Posted Date January 29, 2018
Actual Study Start Date November 8, 2017
Estimated Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 10, 2017)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03343470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 10, 2017)
  • 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
  • Evaluation of cortisol circadian rhythm [ Time Frame: 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 [ 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Circadian Rhythm in CusHing SyndrOme in Active Phase and dUring RemiSsion (TheHOURS)
Official Title The Observational Prospective Multicentric Study on Melatonin and Cortisol Circadian Rhythm in CusHing SyndrOme Patients in Active Phase and dUring RemiSsion.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cushing Syndrome patients in active phase and during remission at 3 and 6 months.
Condition Cushing Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 10, 2017)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2018
Estimated Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03343470
Other Study ID Numbers Adrenal_2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Andrea M. Isidori, University of Roma La Sapienza
Study Sponsor University of Roma La Sapienza
Collaborators
  • Federico II University
  • University of Palermo
  • University of Florence
  • Ospedali Riuniti Ancona
  • University of Padova
Investigators
Principal Investigator: Andrea M Isidori, MD, PhD Dept. Experimental Medicine
PRS Account University of Roma La Sapienza
Verification Date January 2018