NCT02568982

Cushing's Disease Complications

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cushing's Disease

Interventions

Type	Name	Description
OTHER	Exams 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)

Timeline

• Start date: 2015-09-21
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2015-10-06
• Last updated: 2026-03-30

Locations

1 site across 1 country: France