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
Simon B Hansen, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05521529
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Aarhus, State, 8200, Denmark
Location status: Recruiting
Jelena Stankovic, MD
SUB_INVESTIGATOR
Simon B Hansen, MD
CONTACT
Simon B Hansen, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
no intervention
Time frame: Baseline, 3 months after and 1 year after treatment
Questionnaire filled out by patients
Time frame: Baseline, 3 months after and 1 year
Blood pressure, both standard office readings and as AOBP (Automated Office Blood Pressure)
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
Time frame: Baseline, 3 months after and 1 year
Endothelial function will be assessed by the EndoPAT® device (Itamar Medical)
Time frame: Baseline, 3 months after and 1 year
Assessed through fasting blood levels of insulin and glucose (Homeostasis Model Assessment, HOMA)
Time frame: Baseline, 3 months after and 1 year
Assessed as glycated hemoglobin A1C levels measured at three time points
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
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
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.
Time frame: Baseline, 3 months after and 1 year
Dual X-ray absorptiometry (DXA), is used to assess vertebral fractures (VFA).
Time frame: Baseline, 3 months after and 1 year
Change in weight in kilograms
Time frame: Baseline, 3 months after and 1 year
Height and weight are combined to express body mass index (BMI, kg/m2)
Time frame: Baseline, 3 months after and 1 year
waist circumference is recorded with measuring tape.
Time frame: Baseline, 3 months after and 1 year
Hip circumference is recorded with measuring tape.
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
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
Time frame: Baseline, 3 months after and 1 year
Handgrip strength is measured using a hand dynamometer with the participant seated
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
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
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
Time frame: Baseline, 3 months after and 1 year
The questionnaire records types and intensity of physical activity and consists of seven open items
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.
Time frame: Baseline, 3 months after and 1 year
free cortisol
Time frame: Baseline, 3 months after and 1 year
Steroid metabolome
Time frame: Baseline, 3 months after and 1 year
Adrenergic metabolites
Time frame: Baseline, 3 months after and 1 year after treatment
Questionnaire filled out by patients
Time frame: Baseline, 3 months after and 1 year
Questionnaire filled out by patients
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
Time frame: Baseline, 3 months after and 1 year
Such as plasma levels of Adiponectin, Leptin, Free fatty acids, cholesterol
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
Time frame: Baseline, 3 months after and 1 year
Assessed via electronic patient records
Contact information is provided by the study sponsor or research team.
University of Aarhus
Other
Effects of CORtisol Excess and REmission in Cushing's Syndrome Over Time (CORRECT): A Prospective Non-interventional Cohort Study
Acronym: CORRECT
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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