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

NCT06380387 | Recruiting

• 1 other identifier: H-21046543
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CNS Tumor, Childhood

Outcome Measures

Primary Outcomes (16)

• Protein breakdown

  Phenylalanine Rate of appearance micro mol/kgFFM/min

  10 hours

• Protein synthesis

  Phenylalanine Rate of disappearance micro mol/kgFFM/min

  10 hours

• Phenylalanine concentration

  micromol/l

  10 hours

• Phe oxidation to TYR

  micromol/kg FFM/min

  10 hours

• Whole-body protein synthesis

  micromol Phe/kg FFM/min

  10 hours

• Whole-body protein degradation

  micromol Phe /kg FFM/min

  10 hours

• Netto protein balance

  micromol Phe /kg FFM/min

  10 hours

• Glucose Rate of appearance

  micromol/kg FFM/min

  10 hours

• Total glucose Rate of appearance

  micromol/kg FFM/min

  10 hours

• Total glucose Rate of disappearance

  micromol/kg FFM/min

  10 hours

• Endogenous glucose

  micromol/kg FFM/min

  10 hours

• Oral phenylalanine Rate of appearance

  micromol/kg FFM/min

  10 hours

• Phenylalanine oxidation

  % of phenylalanine Rate of appearance

  10 hours

• Rate of Appearance of Palmitate in Plasma

  µmol/kg/min

  10 hours

• Rate of Disappearance of Palmitate

  µmol/kg/min

  10 hours

• Concentration of ketones

  mmol/L

  10 hours

Secondary Outcomes (22)

• Glucose

  10 hours

• Quality of Skeletal Muscle

  10 hours

• Protein synthesis rate

  10 hours

• Pain score

  10 hours

• Life quality score

  10 hours

Study Arms (1)

Meal intervention with stable isotopes

EXPERIMENTAL

A liquid mixed meal are gived adjusted by weight. The meal consists of: Intrinsically labelled D5-Phenylalanine and D3-Leucine labelled casein protein, 13C16palmitate, 13C6-Glucose in a mix of glucose, casein protein and rape seed oil dissolved in water in an energy density of 50% CHO, 35% fat and 15% protein. Blood samples are drawn frequently to measure fat, glucose and protein metabolism.

Dietary Supplement: Meal

Interventions

Meal DIETARY_SUPPLEMENT

Liquid meal

Meal intervention with stable isotopes

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• years
• Signed informed consent to participation in the trial.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, Copenhagen Ø, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Meals

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: April 23, 2024
• Study Start: March 23, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)