Cushing's Syndrome Before and After Treatment (CORRECT)
ConditionCushing Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ACTH-dependent CS
ACTH-independent CS
Age >18 years
Written informed consent
Disqualifiers
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)
Trial population
Patients with newly diagnosed Cushing's Syndrome
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
no intervention, as this is an observational study
Other interventionno intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in CushingQoL-score
Questionnaire filled out by patients
Time frame
Baseline, 3 months after and 1 year after treatmentSecondary outcomes
1
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 year2
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 year3
Change in endothelial function.
Endothelial function will be assessed by the EndoPAT® device (Itamar Medical)
Time frame
Baseline, 3 months after and 1 year4
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 yearOther outcomes
1
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
Time frame
Baseline, 3 months after and 1 year2
Change in metabolic and cardiovascular markers in blood
Such as plasma levels of Adiponectin, Leptin, Free fatty acids, cholesterol
Time frame
Baseline, 3 months after and 1 year3
Change in cytokines levels in blood
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 year4
Participant records: Number of infections, prescriptions for antibiotics
Assessed via electronic patient records
Time frame
Baseline, 3 months after and 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov