NCT03343470

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

6.1 years

First QC Date

November 10, 2017

Last Update Submit

November 22, 2022

Conditions

Cushing Syndrome

Keywords

Cushing SyndromeAdrenal InsufficiencyPeripheral blood mononuclear cellsMelatoninCortisolImmunological profileCushing Disease

Outcome Measures

Primary Outcomes (1)

  • change from baseline in measurement of melatonin secretion at 3 and 6 months

    single outcome measurement of melatonin secretion

    0, +3 months, +6 months

Secondary Outcomes (3)

  • Evaluation of immunological profile at baseline, 3 and 6 months

    0, +3 months, +6 months

  • Evaluation of cortisol circadian rhythm

    0, +3 months, +6 months

  • Change from baseline in measurement of anthropometric-metabolic parameters at 3 and 6 months

    0, +3 months, +6 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cushing Syndrome patients in active phase and during remission at 3 and 6 months.

You may qualify if:

  • Cushing Syndrome during active phase

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Experimental Medicine

Rome, 00161, Italy

RECRUITING

Related Publications (5)

  • Tomova A, Kumanov P, Robeva R, Manchev S, Konakchieva R. Melatonin secretion and non-specific immune responses are differentially expressed in corticotropin-dependent and corticotropin-independent Cushing's syndrome. Med Sci Monit. 2008 Jun;14(6):CR327-332.

    PMID: 18509277RESULT

  • Pivonello R, De Leo M, Cozzolino A, Colao A. The Treatment of Cushing's Disease. Endocr Rev. 2015 Aug;36(4):385-486. doi: 10.1210/er.2013-1048. Epub 2015 Jun 11.

    PMID: 26067718RESULT

  • Piovesan A, Terzolo M, Borretta G, Torta M, Buniva T, Osella G, Paccotti P, Angeli A. Circadian profile of serum melatonin in Cushing's disease and acromegaly. Chronobiol Int. 1990;7(3):259-61. doi: 10.3109/07420529009056984.

    PMID: 2268888RESULT

  • Fevre-Montange M, Tourniaire J, Estour B, Bajard L. 24 hour melatonin secretory pattern in Cushing's syndrome. Clin Endocrinol (Oxf). 1983 Aug;19(2):175-81. doi: 10.1111/j.1365-2265.1983.tb02979.x.

    PMID: 6684004RESULT

  • Angeli A, Gatti G, Sartori ML, Masera RG. Chronobiological aspects of the neuroendocrine-immune network. Regulation of human natural killer (NK) cell activity as a model. Chronobiologia. 1992 Jul-Dec;19(3-4):93-110. No abstract available.

    PMID: 1478121RESULT

MeSH Terms

Conditions

Cushing SyndromeAdrenal InsufficiencyPituitary ACTH Hypersecretion

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Andrea M Isidori, MD, PhD

    Dept. Experimental Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea M Isidori, MD, PhD

CONTACT

+390649970540andrea.isidori@uniroma1.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

November 8, 2017

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

November 23, 2022

Record last verified: 2022-11

Locations

IT(1)