Cushing SyndromeCORRECTNCT05521529
Cushing's Syndrome Before and After Treatment (CORRECT)
An observational study of Cushing Syndrome, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Syndrome
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Feb 2023to Nov 2032
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed Cushing's Syndrome
Who may be able to join
- New (≤ 2 months) diagnosis of Cushing's syndrome (CS) of endogenous etiology:
- ACTH-dependent CS
- ACTH-independent CS
- Age >18 years
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jens Otto Lunde Jørgensen, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Internal Medicine
Aarhus, State, 8200
Simon B Hansen, MD, 41111574, simhan@clin.au.dk
Simon B Hansen, MD
About this study
Official title: Effects of CORtisol Excess and REmission in Cushing's Syndrome Over Time (CORRECT): A Prospective Non-interventional Cohort Study
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.
- Conditions
- Cushing Syndrome
- Being tested
- no intervention, as this is an observational study
- Keywords
- Circadian Rhythm, Quality of Life
- Medical subject headings
- Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, as this is an observational studyOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CushingQoL-score
Questionnaire filled out by patients
Measured: Baseline, 3 months after and 1 year after treatment
Secondary outcomes (26)
Change in blood pressure
Blood pressure, both standard office readings and as AOBP (Automated Office Blood Pressure)
Measured: 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
Measured: Baseline, 3 months after and 1 year
Change in endothelial function.
Endothelial function will be assessed by the EndoPAT® device (Itamar Medical)
Measured: Baseline, 3 months after and 1 year
Change in Insulin resistance
Assessed through fasting blood levels of insulin and glucose (Homeostasis Model Assessment, HOMA)
Measured: Baseline, 3 months after and 1 year
Change in Hba1C
Assessed as glycated hemoglobin A1C levels measured at three time points
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, 3 months after and 1 year
Change in Vertebral Fracture Assessment
Dual X-ray absorptiometry (DXA), is used to assess vertebral fractures (VFA).
Measured: Baseline, 3 months after and 1 year
Change in weight
Change in weight in kilograms
Measured: Baseline, 3 months after and 1 year
Change in BMI
Height and weight are combined to express body mass index (BMI, kg/m2)
Measured: Baseline, 3 months after and 1 year
Change in waist circumference
waist circumference is recorded with measuring tape.
Measured: Baseline, 3 months after and 1 year
Change in hip circumference
Hip circumference is recorded with measuring tape.
Measured: 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
Measured: 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
Measured: Baseline, 3 months after and 1 year
Change in Handgrip strength
Handgrip strength is measured using a hand dynamometer with the participant seated
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, 3 months after and 1 year
Change in 24 hour urinary free cortisol
free cortisol
Measured: Baseline, 3 months after and 1 year
Change in 24 hour urinary steroid metabolome
Steroid metabolome
Measured: Baseline, 3 months after and 1 year
Change in 24 hour urinary adreneric metabolites
Adrenergic metabolites
Measured: Baseline, 3 months after and 1 year
Change in Hospital Anxiety and Depression Scale (HADS) score
Questionnaire filled out by patients
Measured: Baseline, 3 months after and 1 year after treatment
Change in Single item Sleep Quality Scale (SQS) score
Questionnaire filled out by patients
Measured: Baseline, 3 months after and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start16 Feb 2023
- Primary completionOct 2028 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jens Otto Lunde Jørgensen, Professor, Study director, AARHUS UNIVERSITY HOSPITAL, Medical Research Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521529
- Sponsor's protocol ID
- 1-10-72-41-22
- Acronym
- CORRECT
- Status last verified
- Apr 2025
- First submitted
- 16 Aug 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CORtisol Excess and REmission in Cushing's Syndrome Over Time (CORRECT): A Prospective Non-interventional Cohort Study
- ClinicalTrials.gov ID
- NCT05521529
- Acronym / sponsor ID
- CORRECT / 1-10-72-41-22
- Conditions
- Cushing Syndrome
- Keywords
- Circadian Rhythm, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed Cushing's Syndrome
Key inclusion criteria (5 listed)
- New (≤ 2 months) diagnosis of Cushing's syndrome (CS) of endogenous etiology:
- Age >18 years
- Written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, as this is an observational studyno intervention | Other | – |
Primary outcome
Change in CushingQoL-score
Time frame: Baseline, 3 months after and 1 year after treatment
Questionnaire filled out by patients
26 secondary outcomes
Change in blood pressure
Time frame: Baseline, 3 months after and 1 year
Change in arterial stiffness and endothelial function.
Time frame: Baseline, 3 months after and 1 year
Change in endothelial function.
Time frame: Baseline, 3 months after and 1 year
Change in Insulin resistance
Time frame: Baseline, 3 months after and 1 year
Change in Hba1C
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.
Time frame: Baseline, 3 months after and 1 year
Change in body composition
Time frame: Baseline, 3 months after and 1 year
Change in Bone Mineral Density
Time frame: Baseline, 3 months after and 1 year
Change in Vertebral Fracture Assessment
Time frame: Baseline, 3 months after and 1 year
Change in weight
Time frame: Baseline, 3 months after and 1 year
Change in BMI
Time frame: Baseline, 3 months after and 1 year
Change in waist circumference
Time frame: Baseline, 3 months after and 1 year
Change in hip circumference
Time frame: Baseline, 3 months after and 1 year
Change in Timed up and go (TUG)-test
Time frame: Baseline, 3 months after and 1 year
Change in Short Physical Performance Battery (SPPB) and chair rising test - score
Time frame: Baseline, 3 months after and 1 year
Change in Handgrip strength
Time frame: Baseline, 3 months after and 1 year
Change in total physical activity
Time frame: Baseline, 3 months after and 1 year
Change in Sedentary time
Time frame: Baseline, 3 months after and 1 year
Change in total sleep time
Time frame: Baseline, 3 months after and 1 year
Change in IPAQ-S7S
Time frame: Baseline, 3 months after and 1 year
FACS of blood leukocytes
Time frame: Baseline, 3 months after and 1 year
Change in 24 hour urinary free cortisol
Time frame: Baseline, 3 months after and 1 year
Change in 24 hour urinary steroid metabolome
Time frame: Baseline, 3 months after and 1 year
Change in 24 hour urinary adreneric metabolites
Time frame: Baseline, 3 months after and 1 year
Change in Hospital Anxiety and Depression Scale (HADS) score
Time frame: Baseline, 3 months after and 1 year after treatment
Change in Single item Sleep Quality Scale (SQS) score
Time frame: Baseline, 3 months after and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens Otto Lunde Jørgensen, Professor contact
Jens Otto Lunde Jørgensen, Professor study director
AARHUS UNIVERSITY HOSPITAL, Medical Research Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing Syndrome, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Bøggild Hansen, MD (41111574 ext. +45, simhan@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CushingQoL-score (time frame: Baseline, 3 months after and 1 year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.