Clinical Trial: Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Evaluation of Cardiovascular Risk Profile in Adult Patients With Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency Diagnosed Dur

Brief Summary: Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on the cardiovascular risk profile in adult CAH patients. The objective of this study was to evaluate the cardiovascular risk profile of adult CAH patients.

Detailed Summary:

Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on the cardiovascular risk profile in adult CAH patients. The objective of this study was to evaluate the cardiovascular risk profile of adult CAH patients.

DESIGN: Case control study Primary objective : detection of cardiovascular damage in patients with classical or non classical CAH diagnosed in childhood. The patients will be compared with age- and gender- and tobacco status- matched control.

Secondary objective Study of microvascular function Evaluation of cardiovascular risk factors Total cumulative (TCG) and total average (TAG) glucocorticoid doses will be calculated from pediatric and adult files and correlated to arterial macro- and microcirculatory dysfunction.

Primary outcome Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function Secondary outcome Peripheral and central blood pressure Skin capillary density and pulse-wave velocity Glucose and insulin during an oral glucose tolerance test Circulating cardiovascular risk markers (hsCRP, adiponectin, Interleukin-6) Lipid profile Anthropometry, fat and lean mass measured by dual-energy X-ray absorptiometry Total cumulative dose of glucocorticoid Number of subjects : 90 patients/90 controls Inclusion criteria of CAH patients

  • Patients > 18 yrs with classical or non classical CAH diagnosed during childhood
  • Absence of known cardiovascular disease
  • Absence of
    Sponsor: Assistance Publique - Hôpitaux de Paris

    Current Primary Outcome: Ultrasound evaluation of intima-media thickness [ Time Frame: day 1 ]

    Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Blood pressure [ Time Frame: day 1 ]
      Peripheral
    • Skin capillary density [ Time Frame: day 1 ]
    • Insulin during an oral glucose tolerance test [ Time Frame: day 1 ]
    • Circulating cardiovascular risk markers [ Time Frame: day 1 ]
      Interleukin-6
    • Lipid profile [ Time Frame: day 1 ]
    • Lean mass measured by dual-energy X-ray absorptiometry [ Time Frame: day 1 ]
    • Total cumulative dose of glucocorticoid will be calculated from pediatric and adult files [ Time Frame: day 1 ]
      Calculated from pediatric and adult files
    • Pulse-wave velocity [ Time Frame: day 1 ]
    • Glucose during an oral glucose tolerance test [ Time Frame: day 1 ]
    • Anthropometry measured by dual-energy X-ray absorptiometry [ Time Frame: day 1 ]
    • Fat measured by dual-energy X-ray absorptiometry [ Time Frame: day 1 ]
    • Blood pressure [ Time Frame: day 1 ]
      Central
    • Circulating cardiovascular risk markers [ Time Frame: day 1 ]
      hsCRP
    • Circulating cardiovascular risk markers [ Time Frame: day 1 ]
      adiponectin


    Original Secondary Outcome: Same as current

    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: November 16, 2012
    Date Started: May 2011
    Date Completion:
    Last Updated: June 16, 2016
    Last Verified: May 2016