Clinical trial NCT02568982: Cushing's Disease Complications
Official title: Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cushing's Disease
Keywords: Cushing's disease
Quality of life
Metabolic
patients with Cushing's disease
cardiovascular
thromboembolic
bone complications
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cushing 's disease

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).

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

Primary outcomes:
measure: number of complications (hormonal and imaging results, quality of life) per patient (composite)
timeFrame: from diagnosis until 3 years of treatment
Secondary outcomes:
measure: Remission rate of Cushing's disease
timeFrame: 1 year after treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jerome Bertherat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: