Cushing's Syndrome Before and After Treatment (CORRECT)

Recruiting

• Conditions: Cushing Syndrome

• Registration Number: NCT05521529
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Study Start: 2023-02-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2028-10
• Study Completion: 2032-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in CushingQoL-score	Baseline, 3 months after and 1 year after treatment	Questionnaire filled out by patients

Secondary Outcome Measures

Name	Time	Method
Change in Hospital Anxiety and Depression Scale (HADS) score	Baseline, 3 months after and 1 year after treatment	Questionnaire filled out by patients
Change in Insulin resistance	Baseline, 3 months after and 1 year	Assessed through fasting blood levels of insulin and glucose (Homeostasis Model Assessment, HOMA)
Change in Vertebral Fracture Assessment	Baseline, 3 months after and 1 year	Dual X-ray absorptiometry (DXA), is used to assess vertebral fractures (VFA).
Change in total physical activity	Baseline, 3 months after and 1 year	Measured with an Actigraph tri-axial accelerometer on the non-dominant wrist. Expressed as Counts/day
Change in 24 hour urinary adreneric metabolites	Baseline, 3 months after and 1 year	Adrenergic metabolites
Change in Hba1C	Baseline, 3 months after and 1 year	Assessed as glycated hemoglobin A1C levels measured at three time points
Change in Messenger RNA expression of core clock genes in blood leukocytes and biopsies of skeletal muscle and adipose tissue.	Baseline, 3 months after and 1 year	Messenger RNA expression of core clock genes such as BMAL1, CLOCK, PER1-3, CRY1-2, REV-ERBα -β and -γ, RORA-C will be determined. For comparison, housekeeping genes such as Glyceraldehyde-3-phosphate dehydrogenase (GAPDH), β2 microglobulin (B2M) and β-actin (ACTB) will be used.; All will be expressed as -fold change from baseline expression levels
Change in total sleep time	Baseline, 3 months after and 1 year	Measured with an Actigraph tri-axial accelerometer on the non-dominant wrist. Expressed as hours/day
Change in blood pressure	Baseline, 3 months after and 1 year	Blood pressure, both standard office readings and as AOBP (Automated Office Blood Pressure)
Change in Bone Mineral Density	Baseline, 3 months after and 1 year	Dual X-ray absorptiometry (DXA), bone mineral density (BMD) of the lumbar spine and femoral neck.
Change in weight	Baseline, 3 months after and 1 year	Change in weight in kilograms
Change in Sedentary time	Baseline, 3 months after and 1 year	Measured with an Actigraph tri-axial accelerometer on the non-dominant wrist. Expressed as hours/day
Change in IPAQ-S7S	Baseline, 3 months after and 1 year	The questionnaire records types and intensity of physical activity and consists of seven open items
Change in 24 hour urinary free cortisol	Baseline, 3 months after and 1 year	free cortisol
Change in arterial stiffness and endothelial function.	Baseline, 3 months after and 1 year	Arterial stiffness is assessed as Carotid-femoral PWV (cfPWV), measured using the SphygmoCor device (version 9; AtCor Medical
Change in endothelial function.	Baseline, 3 months after and 1 year	Endothelial function will be assessed by the EndoPAT® device (Itamar Medical)
Change in body composition	Baseline, 3 months after and 1 year	Dual X-ray absorptiometry (DXA), is used to measure whole body lean body mass, and fat mass in gram
Change in BMI	Baseline, 3 months after and 1 year	Height and weight are combined to express body mass index (BMI, kg/m2)
Change in Timed up and go (TUG)-test	Baseline, 3 months after and 1 year	The TUG Test combines measures of physical performance and coordination. The TUG test measures the time to stand up, walk 3 m in a straight line, and immediately return to the chair.; The result is expressed as the fastest time in seconds
Change in waist circumference	Baseline, 3 months after and 1 year	waist circumference is recorded with measuring tape.
Change in hip circumference	Baseline, 3 months after and 1 year	Hip circumference is recorded with measuring tape.
Change in Single item Sleep Quality Scale (SQS) score	Baseline, 3 months after and 1 year	Questionnaire filled out by patients
Change in Short Physical Performance Battery (SPPB) and chair rising test - score	Baseline, 3 months after and 1 year	The short physical performance battery (SPPB) is a group of bed-side measures that combines the results of walking speed, chair stand and balance tests.; The result is expressed as a collective score from 0-12
Change in Handgrip strength	Baseline, 3 months after and 1 year	Handgrip strength is measured using a hand dynamometer with the participant seated
FACS of blood leukocytes	Baseline, 3 months after and 1 year	Flow assisted cell sorting (FACS) will be performed on blood leukocytes followed by real time quantitative polymerase chain reaction on distinct cells or in single cell suspension from relevant tissue.
Change in 24 hour urinary steroid metabolome	Baseline, 3 months after and 1 year	Steroid metabolome

Trial Locations

Locations (1)

Department of Endocrinology and Internal Medicine; 🇩🇰 Aarhus, State, Denmark