Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia

Completed

• Conditions: Congenital Adrenal Hyperplasia

• Registration Number: NCT01807364
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-08
• Primary Completion: 2015-09
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound evaluation of intima-media thickness	day 1	Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pitié Salpêtrière Hospital; 🇫🇷 Paris, France