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NCT Number: NCT05521529

Cushing's Syndrome Before and After Treatment (CORRECT)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Endocrinology and Internal Medicine

Aarhus, State, 8200, Denmark

Location status: Recruiting

Location contact

Jelena Stankovic, MD

SUB_INVESTIGATOR

Simon B Hansen, MD

CONTACT

[email protected]

41111574

Simon B Hansen, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention, as this is an observational study

Other

no intervention

Primary outcomes

  1. Change in CushingQoL-score

    Time frame: Baseline, 3 months after and 1 year after treatment

    Questionnaire filled out by patients

Secondary outcomes

  1. Change in blood pressure

    Time frame: Baseline, 3 months after and 1 year

    Blood pressure, both standard office readings and as AOBP (Automated Office Blood Pressure)

  2. Change in arterial stiffness and endothelial function.

    Time frame: 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

  3. Change in endothelial function.

    Time frame: Baseline, 3 months after and 1 year

    Endothelial function will be assessed by the EndoPAT® device (Itamar Medical)

  4. Change in Insulin resistance

    Time frame: Baseline, 3 months after and 1 year

    Assessed through fasting blood levels of insulin and glucose (Homeostasis Model Assessment, HOMA)

  5. Change in Hba1C

    Time frame: Baseline, 3 months after and 1 year

    Assessed as glycated hemoglobin A1C levels measured at three time points

  6. 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

    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

  7. Change in body composition

    Time frame: 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

  8. Change in Bone Mineral Density

    Time frame: Baseline, 3 months after and 1 year

    Dual X-ray absorptiometry (DXA), bone mineral density (BMD) of the lumbar spine and femoral neck.

  9. Change in Vertebral Fracture Assessment

    Time frame: Baseline, 3 months after and 1 year

    Dual X-ray absorptiometry (DXA), is used to assess vertebral fractures (VFA).

  10. Change in weight

    Time frame: Baseline, 3 months after and 1 year

    Change in weight in kilograms

  11. Change in BMI

    Time frame: Baseline, 3 months after and 1 year

    Height and weight are combined to express body mass index (BMI, kg/m2)

  12. Change in waist circumference

    Time frame: Baseline, 3 months after and 1 year

    waist circumference is recorded with measuring tape.

  13. Change in hip circumference

    Time frame: Baseline, 3 months after and 1 year

    Hip circumference is recorded with measuring tape.

  14. Change in Timed up and go (TUG)-test

    Time frame: 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

  15. Change in Short Physical Performance Battery (SPPB) and chair rising test - score

    Time frame: 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

  16. Change in Handgrip strength

    Time frame: Baseline, 3 months after and 1 year

    Handgrip strength is measured using a hand dynamometer with the participant seated

  17. Change in total physical activity

    Time frame: Baseline, 3 months after and 1 year

    Measured with an Actigraph tri-axial accelerometer on the non-dominant wrist. Expressed as Counts/day

  18. Change in Sedentary time

    Time frame: Baseline, 3 months after and 1 year

    Measured with an Actigraph tri-axial accelerometer on the non-dominant wrist. Expressed as hours/day

  19. Change in total sleep time

    Time frame: Baseline, 3 months after and 1 year

    Measured with an Actigraph tri-axial accelerometer on the non-dominant wrist. Expressed as hours/day

  20. Change in IPAQ-S7S

    Time frame: Baseline, 3 months after and 1 year

    The questionnaire records types and intensity of physical activity and consists of seven open items

  21. FACS of blood leukocytes

    Time frame: 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.

  22. Change in 24 hour urinary free cortisol

    Time frame: Baseline, 3 months after and 1 year

    free cortisol

  23. Change in 24 hour urinary steroid metabolome

    Time frame: Baseline, 3 months after and 1 year

    Steroid metabolome

  24. Change in 24 hour urinary adreneric metabolites

    Time frame: Baseline, 3 months after and 1 year

    Adrenergic metabolites

  25. Change in Hospital Anxiety and Depression Scale (HADS) score

    Time frame: Baseline, 3 months after and 1 year after treatment

    Questionnaire filled out by patients

  26. Change in Single item Sleep Quality Scale (SQS) score

    Time frame: Baseline, 3 months after and 1 year

    Questionnaire filled out by patients

Other outcomes

  1. Change in coagulation and inflammation markers in blood

    Time frame: Baseline, 3 months after and 1 year

    Such as ADAM17 (Tumor necrosis factor-α-converting enzyme - TACE) Soluble CD16 (Human Low affinity immunoglobulin gamma Fc region receptor III-A) Fibrinogen vWF D-dimer Plasminogen, plasminogen activator inhibitor 1 Plasmin inhibitor

  2. Change in metabolic and cardiovascular markers in blood

    Time frame: Baseline, 3 months after and 1 year

    Such as plasma levels of Adiponectin, Leptin, Free fatty acids, cholesterol

  3. Change in cytokines levels in blood

    Time frame: Baseline, 3 months after and 1 year

    Such as Interleukin 6 Interleukin 10 Tumor necrosis factor alfa Transforming growth factor alfa

    Measured with cytokine luminex

  4. Participant records: Number of infections, prescriptions for antibiotics

    Time frame: Baseline, 3 months after and 1 year

    Assessed via electronic patient records

Study contacts

Contact information is provided by the study sponsor or research team.

Jens Otto Lunde Jørgensen, Professor

CONTACT

[email protected]

Simon Bøggild Hansen, MD

CONTACT

[email protected]

41111574 ext. +45

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: CORRECT

Important dates

Study start
2023
Primary completion
2028
Study completion
2032
First posted
Aug 30, 2022
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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