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CompletedNCT02568982COMPLICUSHINGUpdated Mar 30, 2026

Cushing's Disease Complications

An observational study in Cushing's Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Cushing's Disease

Keywords

  • Cushing's disease
  • Quality of life
  • Metabolic
  • patients with Cushing's disease
  • cardiovascular
  • thromboembolic
  • bone complications
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cushing 's disease

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • patient with Cushing's disease

    Other: Exams and questionnaires

Interventions

  • OtherExams 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)

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: from diagnosis until 3 years of treatment

Secondary outcomes

  1. Remission rate of Cushing's disease

    Time frame: 1 year after treatment

06

Study locations

1 site
  • AP-HP, Hôpital Cochin
    Paris, Paris 75014, France
07

Registry details

Key details

Study ID
NCT02568982
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Oct 6, 2015
Start date
Sep 21, 2015
Primary completion
Dec 20, 2019
Completion
Dec 20, 2019
Last update
Mar 30, 2026

Study contacts

Jerome Bertherat, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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