Clinical Trial: Cushing's Disease Complications

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in 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 Summary:

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, tr
    Sponsor: Assistance Publique - Hôpitaux de Paris

    Current Primary Outcome: 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)


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Remission rate of Cushing's disease [ Time Frame: 1 year after treatment ]

    Original Secondary Outcome: Same as current

    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: July 20, 2015
    Date Started: September 2015
    Date Completion: September 2020
    Last Updated: July 5, 2016
    Last Verified: July 2016