Cushing's Disease Complications

Assistance Publique - Hôpitaux de Paris80 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cushing's Disease

Interventions

Exams and questionnairesOTHER

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

AP-HP, Hôpital Cochin

Paris, France

Outcomes

Primary Outcomes

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)

Time frame: from diagnosis until 3 years of treatment

Secondary Outcomes

Remission rate of Cushing's disease

Time frame: 1 year after treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.