Clinical trial NCT01807364: Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia
Official title: Evaluation of Cardiovascular Risk Profile in Adult Patients With Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency Diagnosed During Childhood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Adrenal Hyperplasia
Keywords: Congenital adrenal hyperplasia (CAH)
Cardiovascular risk
Microvascular dysfunction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 18 yrs with classical or non classical CAH diagnosed during childhood and controls

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 description: 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 combined oral contraceptives during the previous month Inclusion criteria of controls
* Age under 18
* Absence of known cardiovascular disease
* Absence of combined oral contraceptives during the previous month

Duration of the inclusion period: 3 years

Eligibility criteria: Inclusion criteria : patients

* Patients \> 18 yrs with classical or non classical CAH diagnosed during childhood
* Absence of known cardiovascular disease
* Absence of combined oral contraceptives during the previous month

Inclusion criteria : controls

* Age \> 18 yrs
* Absence of known cardiovascular disease
* Absence of combined oral contraceptives during the previous month

Exclusion criteria :

* Blood donation during the previous 3 months
* Cardiovascular disease
* Treatment by combined oral contraceptives
* Pregnancy

Primary outcomes:
measure: Ultrasound evaluation of intima-media thickness
timeFrame: day 1
Secondary outcomes:
measure: Blood pressure
timeFrame: day 1
measure: Skin capillary density
timeFrame: day 1
measure: Insulin during an oral glucose tolerance test
timeFrame: day 1
measure: Circulating cardiovascular risk markers
timeFrame: day 1
measure: Lipid profile
timeFrame: day 1
measure: Lean mass measured by dual-energy X-ray absorptiometry
timeFrame: day 1
measure: Total cumulative dose of glucocorticoid will be calculated from pediatric and adult files
timeFrame: day 1
measure: Pulse-wave velocity
timeFrame: day 1
measure: Glucose during an oral glucose tolerance test
timeFrame: day 1
measure: Anthropometry measured by dual-energy X-ray absorptiometry
timeFrame: day 1
measure: Fat measured by dual-energy X-ray absorptiometry
timeFrame: day 1
measure: Blood pressure
timeFrame: day 1
measure: Circulating cardiovascular risk markers
timeFrame: day 1
measure: Circulating cardiovascular risk markers
timeFrame: day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpêtrière Hospital
Study officials:
affiliation: APHP
name: Anne Bachelot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: