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Recruiting Not applicable

Whole Body Metabolism in Children Before and After Treatment of CNS Tumor

NCT06380387 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2023-03-23
Last updated
2024-04-23

Condition(s) studied

CNS Tumor, Childhood

Investigational drug(s) / intervention(s)

Meal

Meal: Liquid meal

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Protein breakdown — 10 hours
    Phenylalanine Rate of appearance micro mol/kgFFM/min
  • Protein synthesis — 10 hours
    Phenylalanine Rate of disappearance micro mol/kgFFM/min
  • Phenylalanine concentration — 10 hours
    micromol/l
  • Phe oxidation to TYR — 10 hours
    micromol/kg FFM/min
  • Whole-body protein synthesis — 10 hours
    micromol Phe/kg FFM/min
  • Whole-body protein degradation — 10 hours
    micromol Phe /kg FFM/min
  • Netto protein balance — 10 hours
    micromol Phe /kg FFM/min
  • Glucose Rate of appearance — 10 hours
    micromol/kg FFM/min
  • Total glucose Rate of appearance — 10 hours
    micromol/kg FFM/min
  • Total glucose Rate of disappearance — 10 hours
    micromol/kg FFM/min
  • Endogenous glucose — 10 hours
    micromol/kg FFM/min
  • Oral phenylalanine Rate of appearance — 10 hours
    micromol/kg FFM/min
  • Phenylalanine oxidation — 10 hours
    % of phenylalanine Rate of appearance
  • Rate of Appearance of Palmitate in Plasma — 10 hours
    µmol/kg/min
  • Rate of Disappearance of Palmitate — 10 hours
    µmol/kg/min
  • Concentration of ketones — 10 hours
    mmol/L

Trial sites (1)

FacilityCityRegionStatus
Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet Copenhagen Copenhagen Ø Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06380387 on ClinicalTrials.gov ↗ ← All trials in Denmark