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临床试验/NCT01605123
NCT01605123已完成不适用

Leipzig Artherobesity Childhood Cohort

University of Leipzig2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
cardiovascular dysfunction

研究概览

简要总结

The investigators hypothesize that cardiovascular and metabolic alterations due to obesity already manifest at childhood age.

To identify these alterations and risk factors, the investigators have established a cohort of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity and inflammation. Follow-up analyses are planned after 2 years (completed) and additionally after 5, 7 and 9 years.

In addition, the investigators will assess the effects of increased physical activity and exercise on cardiovascular function.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • height -2 to +2 SDS
  • pubertal stage adequate for age
  • no medications
  • written consent of guardians and children≥12y
  • weight ≥ -2 SDS

排除标准

  • secondary/syndromal obesity
  • known existing hypertension
  • chronic disease (eg. errors of metabolism)
  • acute illness (eg. respiratory tract infection)
  • previous hypertensive or antidiabetic treatment- weight loss attempts 6 weeks prior to assessment

结局指标

主要结局

cardiovascular dysfunction

时间窗: 7 years

Assessment of endothelial function, carotid intima media thickness, blood pressure, echocardiography, exercise capacity, insulin sensitivity by oGTT, serum lipids

次要结局

未报告次要终点

研究者

发起方
University of Leipzig
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antje Koerner, Prof. Dr. med.

Prof. Dr. med.

University of Leipzig

研究点 (2)

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