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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention, as this is an observational study | Other | no intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CushingQoL-score | Questionnaire filled out by patients | Baseline, 3 months after and 1 year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Blood pressure, both standard office readings and as AOBP (Automated Office Blood Pressure) | Baseline, 3 months after and 1 year |
| Change in arterial stiffness and endothelial function. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in coagulation and inflammation markers in blood | 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 | Baseline, 3 months after and 1 year |
Inclusion Criteria:
New (≤ 2 months) diagnosis of Cushing's syndrome (CS) of endogenous etiology:
Age >18 years
Written informed consent
Exclusion Criteria:
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Patients with newly diagnosed Cushing's Syndrome
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon Bøggild Hansen, MD | Contact | 41111574 | +45 | simhan@clin.au.dk |
| Jens Otto Lunde Jørgensen, Professor | Contact | joj@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jens Otto Lunde Jørgensen, Professor | AARHUS UNIVERSITY HOSPITAL, Medical Research Laboratory | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Internal Medicine | Recruiting | Aarhus | State | 8200 | Denmark |
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| ID | Term |
|---|---|
| D003480 | Cushing Syndrome |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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Whole blood drawn into K-EDTA tubes and stored at -80 degrees celsius
Arterial stiffness is assessed as Carotid-femoral PWV (cfPWV), measured using the SphygmoCor device (version 9; AtCor Medical
| Baseline, 3 months after and 1 year |
| Change in endothelial function. | Endothelial function will be assessed by the EndoPAT® device (Itamar Medical) | Baseline, 3 months after and 1 year |
| Change in Insulin resistance | Assessed through fasting blood levels of insulin and glucose (Homeostasis Model Assessment, HOMA) | Baseline, 3 months after and 1 year |
| Change in Hba1C | Assessed as glycated hemoglobin A1C levels measured at three time points | 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 | 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 | 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. | Baseline, 3 months after and 1 year |
| Change in Vertebral Fracture Assessment | Dual X-ray absorptiometry (DXA), is used to assess vertebral fractures (VFA). | Baseline, 3 months after and 1 year |
| Change in weight | Change in weight in kilograms | Baseline, 3 months after and 1 year |
| Change in BMI | Height and weight are combined to express body mass index (BMI, kg/m2) | Baseline, 3 months after and 1 year |
| Change in waist circumference | waist circumference is recorded with measuring tape. | Baseline, 3 months after and 1 year |
| Change in hip circumference | Hip circumference is recorded with measuring tape. | 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 | 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 | Baseline, 3 months after and 1 year |
| Change in Handgrip strength | Handgrip strength is measured using a hand dynamometer with the participant seated | 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 | 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 | 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 | 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 | 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. | Baseline, 3 months after and 1 year |
| Change in 24 hour urinary free cortisol | free cortisol | Baseline, 3 months after and 1 year |
| Change in 24 hour urinary steroid metabolome | Steroid metabolome | Baseline, 3 months after and 1 year |
| Change in 24 hour urinary adreneric metabolites | Adrenergic metabolites | Baseline, 3 months after and 1 year |
| Change in Hospital Anxiety and Depression Scale (HADS) score | Questionnaire filled out by patients | Baseline, 3 months after and 1 year after treatment |
| Change in Single item Sleep Quality Scale (SQS) score | Questionnaire filled out by patients | Baseline, 3 months after and 1 year |
| Change in metabolic and cardiovascular markers in blood |
Such as plasma levels of Adiponectin, Leptin, Free fatty acids, cholesterol |
| Baseline, 3 months after and 1 year |
| Change in cytokines levels in blood | Such as Interleukin 6 Interleukin 10 Tumor necrosis factor alfa Transforming growth factor alfa Measured with cytokine luminex | Baseline, 3 months after and 1 year |
| Participant records: Number of infections, prescriptions for antibiotics | Assessed via electronic patient records | Baseline, 3 months after and 1 year |