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.
Study Type
OBSERVATIONAL
Enrollment
20
no intervention
Department of Endocrinology and Internal Medicine
Aarhus, State, Denmark
RECRUITINGChange in CushingQoL-score
Questionnaire filled out by patients
Time frame: Baseline, 3 months after and 1 year after treatment
Change in blood pressure
Blood pressure, both standard office readings and as AOBP (Automated Office Blood Pressure)
Time frame: Baseline, 3 months after and 1 year
Change in arterial stiffness and endothelial function.
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
Change in endothelial function.
Endothelial function will be assessed by the EndoPAT® device (Itamar Medical)
Time frame: Baseline, 3 months after and 1 year
Change in Insulin resistance
Assessed through fasting blood levels of insulin and glucose (Homeostasis Model Assessment, HOMA)
Time frame: Baseline, 3 months after and 1 year
Change in Hba1C
Assessed as glycated hemoglobin A1C levels measured at three time points
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.
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
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Time frame: Baseline, 3 months after and 1 year
Change in body composition
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
Change in Bone Mineral Density
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
Change in Vertebral Fracture Assessment
Dual X-ray absorptiometry (DXA), is used to assess vertebral fractures (VFA).
Time frame: Baseline, 3 months after and 1 year
Change in weight
Change in weight in kilograms
Time frame: Baseline, 3 months after and 1 year
Change in BMI
Height and weight are combined to express body mass index (BMI, kg/m2)
Time frame: Baseline, 3 months after and 1 year
Change in waist circumference
waist circumference is recorded with measuring tape.
Time frame: Baseline, 3 months after and 1 year
Change in hip circumference
Hip circumference is recorded with measuring tape.
Time frame: Baseline, 3 months after and 1 year
Change in Timed up and go (TUG)-test
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
Change in Short Physical Performance Battery (SPPB) and chair rising test - score
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
Change in Handgrip strength
Handgrip strength is measured using a hand dynamometer with the participant seated
Time frame: Baseline, 3 months after and 1 year
Change in total physical activity
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
Change in Sedentary time
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
Change in total sleep time
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
Change in IPAQ-S7S
The questionnaire records types and intensity of physical activity and consists of seven open items
Time frame: Baseline, 3 months after and 1 year
FACS of blood leukocytes
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
Change in 24 hour urinary free cortisol
free cortisol
Time frame: Baseline, 3 months after and 1 year
Change in 24 hour urinary steroid metabolome
Steroid metabolome
Time frame: Baseline, 3 months after and 1 year
Change in 24 hour urinary adreneric metabolites
Adrenergic metabolites
Time frame: Baseline, 3 months after and 1 year
Change in Hospital Anxiety and Depression Scale (HADS) score
Questionnaire filled out by patients
Time frame: Baseline, 3 months after and 1 year after treatment
Change in Single item Sleep Quality Scale (SQS) score
Questionnaire filled out by patients
Time frame: Baseline, 3 months after and 1 year