Cushing's Disease Complications — COMPLICUSHING  

Cushing's Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Cushing's Disease
• Pituitary ACTH Hypersecretion

• NCT number: NCT02568982
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Start date: September 21, 2015
• Completion date: December 20, 2019