Cushing's Syndrome Before and After Treatment (CORRECT)

NCT05521529 | Recruiting

• 1 other identifier: 1-10-72-41-22
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to prospectively study patients with Cushing's syndrome before and after treatment, with a special emphasis on physical function, quality of life, and circadian rhythms. The hypotheses are:

• Cushing's syndrome negatively impacts health-related quality of life (HRQoL) and physical functioning
• Cushing's syndrome is associated with altered circadian rhythms at the whole body level and in peripheral target tissues.
• These complications partially reverse following disease control.

Conditions

Cushing Syndrome

Keywords

Circadian Rhythm; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in CushingQoL-score

  Questionnaire filled out by patients

  Baseline, 3 months after and 1 year after treatment

Secondary Outcomes (26)

• Change in blood pressure

  Baseline, 3 months after and 1 year

• Change in arterial stiffness and endothelial function.

  Baseline, 3 months after and 1 year

• Change in endothelial function.

  Baseline, 3 months after and 1 year

• Change in Insulin resistance

  Baseline, 3 months after and 1 year

• Change in Hba1C

  Baseline, 3 months after and 1 year

Other Outcomes (4)

• Change in coagulation and inflammation markers in blood

  Baseline, 3 months after and 1 year

• Change in metabolic and cardiovascular markers in blood

  Baseline, 3 months after and 1 year

• Change in cytokines levels in blood

  Baseline, 3 months after and 1 year

Interventions

no intervention, as this is an observational study OTHER

no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed Cushing's Syndrome

You may qualify if:

• New (≤ 2 months) diagnosis of Cushing's syndrome (CS) of endogenous etiology:
• ACTH-dependent CS
• ACTH-independent CS
• Age \>18 years
• Written informed consent

You may not qualify if:

• Active cancer
• Iatrogenic or malignant cause of CS such as adrenocortical carcinoma
• Chronic heart failure (New York Heart Association class IV)
• Chronic kidney disease Chronic Kidney Disease stage ≥3 (eGFR \>30 ml/min)
• Liver disease in the form of cirrhosis
• Deemed unable to complete the study safely by investigator

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Endocrinology and Internal Medicine

Aarhus, State, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood drawn into K-EDTA tubes and stored at -80 degrees celsius

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Jens Otto Lunde Jørgensen, Professor

  AARHUS UNIVERSITY HOSPITAL, Medical Research Laboratory

  STUDY DIRECTOR

Central Study Contacts

Simon Bøggild Hansen, MD

CONTACT

41111574; simhan@clin.au.dk

Jens Otto Lunde Jørgensen, Professor

CONTACT

joj@clin.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 30, 2022
• Study Start: February 16, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): November 1, 2032
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)