Whole Body Metabolism in Children Before and After Treatment of CNS Tumor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Netto protein balance
研究概览
简要总结
At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome.
By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls.
The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 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
By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, the investigators wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls.
Trial design and time frame:
A prospective, non-randomized, cross-sectional study.
There will be three different patient groups included:
- Patient group A: Children with newly diagnosed CNS tumor
- Patient group B: Children finished treated for CNS tumor
- Healthy controls: Children admitted to the hospital at the Epilepsy monitor unit (EMU)
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient group A: Children with newly diagnosed CNS tumor, included just before the start of treatment or right after possible surgery.
- •Patient group B: Children who have completed treatment for a CNS tumor within the last month.
- •Healthy controls: Children admitted to the EMU because of either
- •Suspected convulsions
- •Nocturnal EEG changes
- •6-18 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.
- •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
Netto protein balance
时间窗: 10 hours
micromol Phe /kg FFM/min
Whole-body protein synthesis
时间窗: 10 hours
micromol Phe/kg FFM/min
Whole-body protein degradation
时间窗: 10 hours
micromol Phe /kg FFM/min
Total glucose Rate of disappearance
时间窗: 10 hours
micromol/kg FFM/min
Rate of Appearance of Palmitate in Plasma
时间窗: 10 hours
µmol/kg/min
Protein breakdown
时间窗: 10 hours
Phenylalanine Rate of appearance micro mol/kgFFM/min
Protein synthesis
时间窗: 10 hours
Phenylalanine Rate of disappearance micro mol/kgFFM/min
Phenylalanine concentration
时间窗: 10 hours
micromol/l
Phe oxidation to TYR
时间窗: 10 hours
micromol/kg FFM/min
Rate of Disappearance of Palmitate
时间窗: 10 hours
µmol/kg/min
Total glucose Rate of appearance
时间窗: 10 hours
micromol/kg FFM/min
Oral phenylalanine Rate of appearance
时间窗: 10 hours
micromol/kg FFM/min
Glucose Rate of appearance
时间窗: 10 hours
micromol/kg FFM/min
Endogenous glucose
时间窗: 10 hours
micromol/kg FFM/min
Phenylalanine oxidation
时间窗: 10 hours
% of phenylalanine Rate of appearance
Concentration of ketones
时间窗: 10 hours
mmol/L
次要结局
- Incretins(10 hours)
- Protein synthesis rate(10 hours)
- Life quality score(10 hours)
- Glucose(10 hours)
- Pain score(10 hours)
- Level of HbA1c(10 hours)
- Quality of Skeletal Muscle(10 hours)
- Glucagon(10 hours)
- Liver parameters ALT, AST, GGT(10 hours)
- Bilirubin(10 hours)
- LDH(10 hours)
- Muscle biopsy(10 hours)
- International normalized ratio (INR)(10 hours)
- catecholamines(10 hours)
- Blood pressure(10 hours)
- Concentration of Plasma Amino Acids(10 hours)
- Concentration of Plasma Free Fatty Acids(10 hours)
- Waist- and hip circumference(10 hours)
- Concentration of Plasma Glucose(10 hours)
- Insulin(10 hours)
- Lipids(10 hours)
- Concentration of Plasma Palmitate(10 hours)
研究者
Mette Cathrine Oerngreen
Principal Investigator
Rigshospitalet, Denmark