Cushing's Disease Complications (COMPLICUSHING)

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

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.

Study Overview

• Status: Completed
• Conditions: Cushing's Disease
• Intervention / Treatment: Other: Exams and questionnaires

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).

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Paris
    • Paris, Paris, France, 75014
      • AP-HP, Hôpital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cushing 's disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient with Cushing's disease	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Remission rate of Cushing's disease	1 year after treatment

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Jerome Bertherat, MD, PhD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2015
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimated): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Metabolic; cardiovascular; thromboembolic; Cushing's disease; patients with Cushing's disease; bone complications
• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Hyperpituitarism; Pituitary Diseases; Pituitary ACTH Hypersecretion; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: P120132