Whole Body Metabolism in Children with Cerebral Palsy with Low Skeletal Muscle Mass
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Protein breakdown
研究概览
简要总结
At the center of pediatrics in Copenhagen the investigators experience that the children with CP with low skeletal muscle mass have more complications and admission after for example surgery is prolonged due to these complications. In order to prevent malnutrition and energy insufficiency as well as obesity and cardiometabolic disorders in adulthood, and with the aim of defining biomarkers for energy needs, the investigators wish to determine energy and protein needs in children with CP.
The investigators wish to investigate the whole-body metabolism in children with cerebral palsy (CP) and compare the results with results from healthy children. The investigators aim to include 10 children (aged 2-18 years) with CP with low skeletal muscle mass and 10 healthy controls (aged 2-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis.
详细描述
Trial design and time frame:
A prospective, non-randomized, cross-sectional study.
There will be two different groups included:
- Children with cerebral palsy with low skeletal muscle mass
- Healthy controls: Children admitted to the hospital at the Epilepsy monitor unit (EMU for conditions not affecting metabolic function)
The trial will be conducted over a total of five days and takes place at the Copenhagen Neuromuscular Centre, Department of Neurology or Department of Pediatrics and Adolescent Medicine, Rigshospitalet
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •-Children with cerebral palsy with low skeletal muscle mass
- •o Being wheelchair dependent GMFCS IV-V
- •Healthy controls: Children admitted to the EMU because of either
- •Classification of epilepsy or to rule out differential diagnoses of epilepsy
- •Nocturnal EEG changes
- •o 2-18 years
- •Signed informed consent to participation in the trial.
排除标准
- •Inability to understand the purpose of the trial or cooperate in the conduction of the experiments. For the children this will concern of course the parents or the guardians of the child.
- •Competing conditions at risk of compromising the results of the study.
- •In healthy children, concerns that participation in the trial may affect the diagnostic quality of the EMU investigation
- •Participation in other trials that may interfere with the results.
- •Intake of medications that may interfere with the results, evaluated by investigator.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Protein breakdown
时间窗: 10 hours
Phenylalanine Rate of appearance micro mol/kgFFM/min in a fasted and fed state
次要结局
- Muscle biopsy(10 hours)
- Life quality score(10 hpurs)
- Quality of Skeletal Muscle(10 hours)
- Metabolities(10 hours)
- Hormones(10 hours)
- Energy utilization(10 hours)
- muscle biopsy(10 hours)
研究者
Mette Cathrine Oerngreen
Principal Investigator
Rigshospitalet, Denmark