Follow-up During the Peripubertal Period of Preterm Children (Under 35 Weeks of Amenorrhea) Included in the "EPIPOD" Protocol : Evaluation of Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Insulin resistance as measured by the Triglyceride-Glucose Index
研究概览
简要总结
Prematurity is associated with an increased risk of developing cardiovascular and metabolic disturbances in adulthood.
It has been demonstrated that the body composition of children born prematurely is different from that of children born under term with a deficit in fat free mass.
It can thus be wondered if this excessive adiposity does or does not predict the risk of insulin resistance in adulthood.
Children born prematurely, with a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol, and now aged between 8 and 14 years, will be included in the INFANTPOD protocol.
Analysis of body composition, insulin resistance, renal function, pulse wave velocity, eating behaviour and of physical activity will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children hospitalised at the Nantes University Hospital in the neonatal period
- •With a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol
- •Born prematurely (under 35 weeks of amenorrhea)
- •Included in the Lift cohort with follow-up up to 7 years
- •Aged between 8 and 14 years at inclusion
排除标准
- •Children with an isolated metabolic disease: insulin-dependent diabetes; endocrine disease (Cushing's, hypothyroidism)
- •Age of 15 years or more
- •with a chromosomal anomaly
- •with contraindicating measurement of the BOP-POD: ventilatory support, continuous parenteral feeding, elimination stoma
- •Refusal of either parent or child
研究组 & 干预措施
Children born prematurely included in the EPIPOD protocol and now in the peripubertal period
At inclusion in the INFANTPOD study :
- Blood and urinary samples collection for evaluation of insulin resistance and of renal function analysis.
- Assessment of body composition by a commercialized device called "BOP-POD" and by impedancemetry
- Assessment of pulse wave by a commercialized device called "popmetre"
- Questionnaires for analysis of eating behaviour
- Assessment of physical activity by a commercialized device called "accelerometer" and by questionnaire.
干预措施: clinical and biological measurements and questionnaires (Other)
结局指标
主要结局
Insulin resistance as measured by the Triglyceride-Glucose Index
时间窗: 1 day
次要结局
- Eating behaviour using standardized french questionnaire named "QCAJE Questionnaire Comportement Alimentaire du Jeune Enfant"(1 day)
- creatinine clearance(1 day)
- Eating behaviour using standardized questionnaire named Child Eating Behaviour questionnaire(1 day)
- Body composition (percentage of fat versus fat free mass) by BOP-POD and by impedancemetry (biodyXpert) for assessment of body composition variations between peripubertal period and neonatal period(1 day)
- Insulin resistance as measured by the Homeostasis Model Assessment - Insulin Resistance index(1 day)