Low Grade Inflammation in Childhood Obesity : an Independent Risk Factor for Endothelial Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Endothelial cell function
研究概览
简要总结
Eligible candidates will be recruited within the children with overweight and obesity having a metabolic risk evaluation before treatment in the period 2006 and 2010 at the pediatric clinic of the UZ Brussel In total 60 participants will be investigated. Firstly, 30 participating patients with initially elevated hsCRP will be selected at random ( following the date of their initial investigation) and afterwards matched for age, BMI z-score, and blood pressure with the same number of patients without initially elevated hCRP values
Data will be collected as follows:
- questionnaires
- clinical examination/ anthropometry
- blood sample (hsCRP)
- peripheral arterial tonometry (endoPAT)
详细描述
Obesity and overweight have become an important health burden in children and adolescents, with 19% of all children between 5 and 18 years being either obese or overweight in Belgium. Obesity and especially visceral adiposity early in life may contribute to the development of cardiovascular disease at older age, as it shows tracking into adulthood and is be associated with cardiovascular risk factors such as dyslipidemia, insulin resistance, arterial hypertension and low grade inflammation, in a variable percentage.
Low grade inflammation, as assessed by hSCRP, was found to be present in 20.6 % and 19.8 % of overweight children and adolescents. In adults, hSCRP levels between 1 and 3 mg/L and above 3 mg/L are considered coronary disease risk factors.
Endothelial dysfunction, know to precede the formation of atherosclerotic plaque, can be assessed in a non-invasive manner in children by peripheral artery tonometry. Only few studies have been performed in obese children with this bed-side technique, showing either normal of a disturbed function, reflected by a lower reactive hyperemia index. The association with low grade inflammation however was assessed in only one study. The investigators hypothesize that in adolescents and young adults with a history of childhood obesity a more disturbed endothelial function will be present in those with and /or current elevated hSCRP value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-21 years at the moment of evaluation
- •BMI > 1.3 Standard Deviation Score at the initial evaluation
- •Hs-CRP available at initial evaluation
排除标准
- •Acute of chronic Infection at the time of the study visit
- •Be or have been a smoker of tabacco
研究组 & 干预措施
Baseline high hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Anthropometry (Diagnostic Test)
Baseline high hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Blood pressure (Diagnostic Test)
Baseline high hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Blood sample (Diagnostic Test)
Baseline high hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Peripheral arterial tonometry (Diagnostic Test)
Baseline high hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Questionnaire (Other)
Baseline low hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Anthropometry (Diagnostic Test)
Baseline low hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Blood pressure (Diagnostic Test)
Baseline low hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Peripheral arterial tonometry (Diagnostic Test)
Baseline low hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Questionnaire (Other)
Baseline low hs-CRP
Anthropometry:
- Actual Height and weight
- Calculated BMI from measured weight and height.
- Pubertal development (Tanner stage)
- Waist circumference
- Skin fold measurement (Triceps and Subscapular)
- Waist-to-height ratio.
Blood pressure (mean of 3 measurements)
Peripheral arterial tonometry
Questionnaire
Blood sample (hsCRP)
干预措施: Blood sample (Diagnostic Test)
结局指标
主要结局
Endothelial cell function
时间窗: through study completion, an average of 1 year (measured once)
Reactive hyperemia index (RHI) measured by the EndoPAT device.
次要结局
- hs CRP level(through study completion, an average of 1 year (measured once))
- BMI z-score(through study completion, an average of 1 year (measured once))
- Fat percentage by skin fold measurements(through study completion, an average of 1 year (measured once))
研究者
Inge Gies
Professor
Universitair Ziekenhuis Brussel