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Completed

NCT Number: NCT02568982

Cushing's Disease Complications

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.

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Key information

Conditions

Cushing's Disease Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Nervous System Diseases Pituitary ACTH Hypersecretion Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Hôpital Cochin

Paris, 75014, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exams and questionnaires

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)

Primary outcomes

  1. number of complications (hormonal and imaging results, quality of life) per patient (composite)

    Time frame: from diagnosis until 3 years of treatment

    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)

Secondary outcomes

  1. Remission rate of Cushing's disease

    Time frame: 1 year after treatment

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: COMPLICUSHING

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2015
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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