Cushing's Disease Complications

NCT ID: NCT02568982

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-21
• Study Completion Date: 2019-12-20

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).

Conditions

Cushing's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patient with Cushing's disease

Exams and questionnaires

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerome Bertherat, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

AP-HP, Hôpital Cochin

Paris, , France

Countries

France

Other Identifiers

P120132

Identifier Type: -

Identifier Source: org_study_id