跳至主要内容
临床试验/NCT01807364
NCT01807364已完成不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2011年5月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验