Cushing's Disease Complications (COMPLICUSHING)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Cushing's Disease

Treatments: Other: Exams and questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT02568982

P120132

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

patient with Cushing's disease

Treatment:

Other: Exams and questionnaires