Actively Recruiting
Effects of CORtisol Excess and REmission in Cushing's Syndrome Over Time (CORRECT): A Prospective Non-interventional Cohort Study
Led by University of Aarhus · Updated on 2025-04-04
20
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with Cushing's syndrome to understand how the condition affects physical function, quality of life, and circadian rhythms both before and after treatment. The study aims to evaluate the negative impacts of Cushing's syndrome on health-related quality of life and physical abilities, as well as how the condition alters circadian rhythms in the body and peripheral tissues. The research also explores how some of these complications may improve after the disease is controlled. This observational study does not involve any interventions or treatments assigned by the researchers. Instead, it follows patients diagnosed with endogenous Cushing's syndrome, including both ACTH-dependent and ACTH-independent types, over time to monitor changes related to their condition and treatment. Assessments occur at baseline, then again at 3 months and 1 year after treatment to observe changes in various health measures. Participants will undergo evaluations including quality of life questionnaires, blood pressure checks, tests of arterial stiffness and endothelial function, insulin resistance, body composition, bone density, physical performance tests, and sleep and activity monitoring. Researchers will also analyze gene expression in blood and tissue samples and measure hormone and metabolite levels in urine. Safety and mental health are assessed with standardized scales. The total follow-up period for each participant is approximately one year after treatment initiation.
CONDITIONS
Brief Title
Cushing's Syndrome Before and After Treatment (CORRECT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New diagnosis of Cushing's syndrome (endogenous) within 2 months, including ACTH-dependent or ACTH-independent types
- Age over 18 years
- Provided written informed consent
You will not qualify if you...
- Active cancer
- Iatrogenic or malignant Cushing's syndrome such as adrenocortical carcinoma
- Chronic heart failure classified as New York Heart Association class IV
- Chronic kidney disease stage 3 or higher (eGFR ≤30 ml/min)
- Liver cirrhosis
- Considered unable to safely complete the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline period
Participants undergo baseline assessments including physical measurements, blood and urine tests, and questionnaires to evaluate health status before treatment.
1 visit (in-person)
Duration - 1 year
Participants are followed over time with repeated assessments at 3 months and 1 year after treatment to monitor changes in health outcomes.
2 visits (in-person) at 3 months and 1 year after treatment
Trial Site Locations
Total: 1 location
1
Department of Endocrinology and Internal Medicine
Aarhus, State, Denmark, 8200
Actively Recruiting
Research Team
S
Simon Bøggild Hansen, MD
J
Jens Otto Lunde Jørgensen, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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