Cushing's Disease Complications

Study Overview
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Brief Summary
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This study aims at investigating the complications of Cushing's disease in de novo patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.

Detailed Description
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At inclusion the following will be investigated and recorded : demographic and personal medical history. Familial medical history related to osteoporosis, cardiovascular disorders and thromboembolism. Current medical treatment. Physical examination. Assessment of basal 24hrs urinary cortisol and salivary cortisol. - At baseline (i.e. before specific treatment of Cortisol excess): physical examination, routine biology, HbA1C, fasting glucose and oral glucose load, cholesterol, triglyceride, HDL & LDL, coagulation and fibrinolysis investigation, 24hrs urinary cortisol and salivary cortisol, urinary labstick test. EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US, ophthalmology examination, spine X-Ray, bone densitometry, QoL questionnaires (SF-36, QoLCushing, Beck BDI-II). Every year during a 3 years follow-up the following will be investigated : Current medical treatment. Physical examination. Assessment of basal routine biology, HbA1C, fasting glucose, cholesterol, triglyceride, HDL & LDL, coagulation and fibrinolysis investigation, 24hrs urinary cortisol and salivary cortisol, urinary labstick test. EKG, cardiac ultrasound, cardiac CT-scan (if abnormal initially), arterial and venous US, ophthalmology examination, bone densitometry, QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).

Official Title
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Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease

Conditions
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Cushing's Disease

Intervention / Treatment
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* Other: Exams and questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cushing's disease diagnosed by complementary explorations according to the National Program of Diagnosis and Care of the Cushing 's disease Exclusion Criteria: other cause of Cushing's syndrome known inherited syndrome having for consequence an hormonal hypersecretion (NEM-1, complexe of carney, McCuneAlbright syndrome) patient does not understand french life expectancy of less than 6 months pregnant women dependent patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient with Cushing's disease<br> | Other: Exams and questionnaires<br>* Blood sample 24hrs urinary cortisol and salivary cortisol, urinary labstick test, EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US ophthalmology examination spine X-Ray bone densitometry QoL questionnaires (SF-36, QoLCushing, Beck BDI-II)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of complications (hormonal and imaging results, quality of life) per patient (composite) | Evaluate the frequency of : metabolic complications (HbA1C, fasting glucose and oral glucose load, cholesterol, triglyceride, HDL & LDL, coagulation and fibrinolysis investigation, 24hrs urinary cortisol and salivary cortisol, urinary labstick test) cardiovascular thromboembolic complications (EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US) bone complications (spine X-Ray, bone densitometry) quality of life alteration measured by questionnaires (SF36, QoLCushing, Beck BDI-II) | from diagnosis until 3 years of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate of Cushing's disease |  | 1 year after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cushing's disease, Quality of life, Metabolic, patients with Cushing's disease, cardiovascular, thromboembolic, bone complications