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Recruiting Not applicable

Whole Body Metabolism in Children With Cerebral Palsy With Low Skeletal Muscle Mass

NCT06486597 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2023-08-01
Last updated
2025-02-26

Condition(s) studied

Cerebral Palsy (CP)

Investigational drug(s) / intervention(s)

Meal

Meal: Liquid meal

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria: * -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 Age: o 2-18 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. * 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.

Primary outcome measure(s)

  • Protein breakdown — 10 hours
    Phenylalanine Rate of appearance micro mol/kgFFM/min in a fasted and fed state

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 NCT06486597 on ClinicalTrials.gov ↗ ← All trials in Denmark