Cushing's Disease Complications

Cushing's Disease Clinical Trial

— COMPLICUSHING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568982
• Other study ID #: P120132
• Status: Completed
• Start date: September 21, 2015
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
France	AP-HP, Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	from diagnosis until 3 years of treatment
Secondary	Remission rate of Cushing's disease		1 year after treatment