Evaluation of Cardiovascular Risk Profile in Adult Patients With Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency Diagnosed During Childhood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Ultrasound evaluation of intima-media thickness
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Ultrasound evaluation of intima-media thickness
时间窗: day 1
Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function
次要结局
- 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)
- Skin capillary density(day 1)
- Circulating cardiovascular risk markers(day 1)
- Fat measured by dual-energy X-ray absorptiometry(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(day 1)
- Pulse-wave velocity(day 1)
- Anthropometry measured by dual-energy X-ray absorptiometry(day 1)
