Cushing's Syndrome Before and After Treatment (CORRECT)

Cushing Syndrome Clinical Trial

— CORRECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521529
• Other study ID #: 1-10-72-41-22
• Status: Recruiting
• Start date: February 16, 2023
• Est. completion date: November 2032

Study information

• Verified date: September 2023
• Source: University of Aarhus
• Contact: Simon Bøggild Hansen, MD
• Phone: 41111574
• Email: simhan[@]clin.au.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2032
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cushing Syndrome
• Syndrome

Intervention

Other:
• no intervention, as this is an observational study
no intervention

Locations

Country	Name	City	State
Denmark	Department of Endocrinology and Internal Medicine	Aarhus	State

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in coagulation and inflammation markers in blood	Such as ADAM17 (Tumor necrosis factor-a-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
Other	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
Other	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
Other	Participant records: Number of infections, prescriptions for antibiotics	Assessed via electronic patient records	Baseline, 3 months after and 1 year
Primary	Change in CushingQoL-score	Questionnaire filled out by patients	Baseline, 3 months after and 1 year after treatment
Secondary	Change in blood pressure	Blood pressure, both standard office readings and as AOBP (Automated Office Blood Pressure)	Baseline, 3 months after and 1 year
Secondary	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	Baseline, 3 months after and 1 year
Secondary	Change in endothelial function.	Endothelial function will be assessed by the EndoPAT® device (Itamar Medical)	Baseline, 3 months after and 1 year
Secondary	Change in Insulin resistance	Assessed through fasting blood levels of insulin and glucose (Homeostasis Model Assessment, HOMA)	Baseline, 3 months after and 1 year
Secondary	Change in Hba1C	Assessed as glycated hemoglobin A1C levels measured at three time points	Baseline, 3 months after and 1 year
Secondary	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-ERBa -ß and -?, RORA-C will be determined. For comparison, housekeeping genes such as Glyceraldehyde-3-phosphate dehydrogenase (GAPDH), ß2 microglobulin (B2M) and ß-actin (ACTB) will be used.; All will be expressed as -fold change from baseline expression levels	Baseline, 3 months after and 1 year
Secondary	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
Secondary	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
Secondary	Change in Vertebral Fracture Assessment	Dual X-ray absorptiometry (DXA), is used to assess vertebral fractures (VFA).	Baseline, 3 months after and 1 year
Secondary	Change in weight	Change in weight in kilograms	Baseline, 3 months after and 1 year
Secondary	Change in BMI	Height and weight are combined to express body mass index (BMI, kg/m2)	Baseline, 3 months after and 1 year
Secondary	Change in waist circumference	waist circumference is recorded with measuring tape.	Baseline, 3 months after and 1 year
Secondary	Change in hip circumference	Hip circumference is recorded with measuring tape.	Baseline, 3 months after and 1 year
Secondary	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
Secondary	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
Secondary	Change in Handgrip strength	Handgrip strength is measured using a hand dynamometer with the participant seated	Baseline, 3 months after and 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in 24 hour urinary free cortisol	free cortisol	Baseline, 3 months after and 1 year
Secondary	Change in 24 hour urinary steroid metabolome	Steroid metabolome	Baseline, 3 months after and 1 year
Secondary	Change in 24 hour urinary adreneric metabolites	Adrenergic metabolites	Baseline, 3 months after and 1 year
Secondary	Change in Hospital Anxiety and Depression Scale (HADS) score	Questionnaire filled out by patients	Baseline, 3 months after and 1 year after treatment
Secondary	Change in Single item Sleep Quality Scale (SQS) score	Questionnaire filled out by patients	Baseline, 3 months after and 1 year