Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Congenital Adrenal Hyperplasia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Congenital adrenal hyperplasia<br>Patients > 18 yrs with classical or non classical CAH diagnosed during childhood | |
| controls<br>control patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound evaluation of intima-media thickness | Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function | day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital adrenal hyperplasia (CAH), Cardiovascular risk, Microvascular dysfunction