Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia
NCT ID: NCT01807364
Last Updated: 2016-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
170 participants
OBSERVATIONAL
2011-05-31
2016-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Congenital adrenal hyperplasia
Patients \> 18 yrs with classical or non classical CAH diagnosed during childhood
No interventions assigned to this group
controls
control patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Absence of known cardiovascular disease
* Absence of combined oral contraceptives during the previous month
* Age \> 18 yrs
* Absence of known cardiovascular disease
* Absence of combined oral contraceptives during the previous month
Exclusion Criteria
* Cardiovascular disease
* Treatment by combined oral contraceptives
* Pregnancy
18 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Anne Bachelot, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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Pitié Salpêtrière Hospital
Paris, , France
Countries
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Other Identifiers
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P091106
Identifier Type: OTHER
Identifier Source: secondary_id
AOR 10032
Identifier Type: -
Identifier Source: org_study_id
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