Cushing's Disease
Conditions
Keywords
Cushing's disease, Quality of life, Metabolic, patients with Cushing's disease, cardiovascular, thromboembolic, bone complications
Brief summary
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
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).
Interventions
OTHERExams and questionnaires
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)
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of complications (hormonal and imaging results, quality of life) per patient (composite) | from diagnosis until 3 years of treatment | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate of Cushing's disease | 1 year after treatment |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJerome Bertherat, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed