Clinical trial NCT05521529: Cushing's Syndrome Before and After Treatment (CORRECT)
Official title: Effects of CORtisol Excess and REmission in Cushing's Syndrome Over Time (CORRECT): A Prospective Non-interventional Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cushing Syndrome
Keywords: Circadian Rhythm
Quality of Life
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2022-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed Cushing's Syndrome

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.


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

Primary outcomes:
measure: Change in CushingQoL-score
timeFrame: Baseline, 3 months after and 1 year after treatment
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline, 3 months after and 1 year
measure: Change in arterial stiffness and endothelial function.
timeFrame: Baseline, 3 months after and 1 year
measure: Change in endothelial function.
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Insulin resistance
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Hba1C
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Messenger RNA expression of core clock genes in blood leukocytes and biopsies of skeletal muscle and adipose tissue.
timeFrame: Baseline, 3 months after and 1 year
measure: Change in body composition
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Bone Mineral Density
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Vertebral Fracture Assessment
timeFrame: Baseline, 3 months after and 1 year
measure: Change in weight
timeFrame: Baseline, 3 months after and 1 year
measure: Change in BMI
timeFrame: Baseline, 3 months after and 1 year
measure: Change in waist circumference
timeFrame: Baseline, 3 months after and 1 year
measure: Change in hip circumference
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Timed up and go (TUG)-test
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Short Physical Performance Battery (SPPB) and chair rising test - score
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Handgrip strength
timeFrame: Baseline, 3 months after and 1 year
measure: Change in total physical activity
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Sedentary time
timeFrame: Baseline, 3 months after and 1 year
measure: Change in total sleep time
timeFrame: Baseline, 3 months after and 1 year
measure: Change in IPAQ-S7S
timeFrame: Baseline, 3 months after and 1 year
measure: FACS of blood leukocytes
timeFrame: Baseline, 3 months after and 1 year
measure: Change in 24 hour urinary free cortisol
timeFrame: Baseline, 3 months after and 1 year
measure: Change in 24 hour urinary steroid metabolome
timeFrame: Baseline, 3 months after and 1 year
measure: Change in 24 hour urinary adreneric metabolites
timeFrame: Baseline, 3 months after and 1 year
measure: Change in Hospital Anxiety and Depression Scale (HADS) score
timeFrame: Baseline, 3 months after and 1 year after treatment
measure: Change in Single item Sleep Quality Scale (SQS) score
timeFrame: Baseline, 3 months after and 1 year
Other outcomes:
measure: Change in coagulation and inflammation markers in blood
timeFrame: Baseline, 3 months after and 1 year
measure: Change in metabolic and cardiovascular markers in blood
timeFrame: Baseline, 3 months after and 1 year
measure: Change in cytokines levels in blood
timeFrame: Baseline, 3 months after and 1 year
measure: Participant records: Number of infections, prescriptions for antibiotics
timeFrame: Baseline, 3 months after and 1 year
Locations:
city: Aarhus
country: Denmark
facility: Department of Endocrinology and Internal Medicine
state: State
Study officials:
affiliation: AARHUS UNIVERSITY HOSPITAL, Medical Research Laboratory
name: Jens Otto Lunde Jørgensen, Professor
role: STUDY_DIRECTOR
References: