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Recruiting NCT05521529

Cushing's Syndrome Before and After Treatment (CORRECT)

— Observational Cushing Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no intervention, as this is an observational study.
Who it may be relevant to
Registry conditions: Cushing Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of CORtisol Excess and REmission in Cushing's Syndrome Over Time (CORRECT): A Prospective Non-interventional Cohort Study

Overview

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.

Interventions

  • Other no intervention, as this is an observational study
    no intervention

Primary outcome measures

  • Change in CushingQoL-score [Time frame: Baseline, 3 months after and 1 year after treatment]
Secondary outcome measures (12)
  • Change in blood pressure [Time frame: Baseline, 3 months after and 1 year]
  • Change in arterial stiffness and endothelial function. [Time frame: Baseline, 3 months after and 1 year]
  • Change in endothelial function. [Time frame: Baseline, 3 months after and 1 year]
  • Change in Insulin resistance [Time frame: Baseline, 3 months after and 1 year]
  • Change in Hba1C [Time frame: Baseline, 3 months after and 1 year]
  • Change in Messenger RNA expression of core clock genes in blood leukocytes and biopsies of skeletal muscle and adipose tissue. [Time frame: Baseline, 3 months after and 1 year]
  • Change in body composition [Time frame: Baseline, 3 months after and 1 year]
  • Change in Bone Mineral Density [Time frame: Baseline, 3 months after and 1 year]
  • Change in Vertebral Fracture Assessment [Time frame: Baseline, 3 months after and 1 year]
  • Change in weight [Time frame: Baseline, 3 months after and 1 year]
  • Change in BMI [Time frame: Baseline, 3 months after and 1 year]
  • Change in waist circumference [Time frame: Baseline, 3 months after and 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Department of Endocrinology and Internal Medicine — Aarhus

Identifiers

NCT: NCT05521529 · 1-10-72-41-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗