protocolSection identificationModule nctId: NCT06380387, orgStudyIdInfo id: H-21046543, briefTitle: Whole Body Metabolism in Children Before and After Treatment of CNS Tumor, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-23, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: CNS Tumor, Childhood, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Meal, outcomesModule primaryOutcomes measure: Protein breakdown, primaryOutcomes measure: Protein synthesis, primaryOutcomes measure: Phenylalanine concentration, primaryOutcomes measure: Phe oxidation to TYR, primaryOutcomes measure: Whole-body protein synthesis, primaryOutcomes measure: Whole-body protein degradation, primaryOutcomes measure: Netto protein balance, primaryOutcomes measure: Glucose Rate of appearance, primaryOutcomes measure: Total glucose Rate of appearance, primaryOutcomes measure: Total glucose Rate of disappearance, primaryOutcomes measure: Endogenous glucose, primaryOutcomes measure: Oral phenylalanine Rate of appearance, primaryOutcomes measure: Phenylalanine oxidation, primaryOutcomes measure: Rate of Appearance of Palmitate in Plasma, primaryOutcomes measure: Rate of Disappearance of Palmitate, primaryOutcomes measure: Concentration of ketones, secondaryOutcomes measure: Glucose, secondaryOutcomes measure: Quality of Skeletal Muscle, secondaryOutcomes measure: Protein synthesis rate, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Life quality score, secondaryOutcomes measure: Muscle biopsy, secondaryOutcomes measure: Incretins, secondaryOutcomes measure: Glucagon, secondaryOutcomes measure: Liver parameters ALT, AST, GGT, secondaryOutcomes measure: Bilirubin, secondaryOutcomes measure: International normalized ratio (INR), secondaryOutcomes measure: LDH, secondaryOutcomes measure: Insulin, secondaryOutcomes measure: catecholamines, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Waist- and hip circumference, secondaryOutcomes measure: Lipids, secondaryOutcomes measure: Concentration of Plasma Amino Acids, secondaryOutcomes measure: Concentration of Plasma Glucose, secondaryOutcomes measure: Concentration of Plasma Palmitate, secondaryOutcomes measure: Concentration of Plasma Free Fatty Acids, secondaryOutcomes measure: Level of HbA1c, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet, status: RECRUITING, city: Copenhagen, state: Copenhagen Ø, zip: 2100, country: Denmark, contacts name: Mette Cathrine Ørngreen, MD, DMSc, role: CONTACT, phone: 35455935, email: mette.cathrine.oerngreen.01@regionh.dk, contacts name: Mette Cathrine Ørngreen, MD, DMSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False