Investigating metabolism in children with cerebral palsy and low muscle mass
Official title: Whole Body Metabolism in Children With Cerebral Palsy With Low Skeletal Muscle Mass
Run by Copenhagen University Hospital, Rigshospitalet · NCT06486597 · Data updated 2026-11-12
This study is testing how metabolism works in children with cerebral palsy and low muscle mass compared to healthy kids to better understand their energy and protein needs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen, Copenhagen Ø) |
| Status | Recruiting |
| Started | August 1, 2023 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | February 26, 2025 |
| Trial ID | NCT06486597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children aged 2-18 years with cerebral palsy who are wheelchair dependent and have low skeletal muscle mass.
✕Probably not a fit
Patients with competing conditions that may compromise study results or those unable to cooperate with the study procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess whole-body metabolism in children with cerebral palsy (CP) who have low skeletal muscle mass, comparing their metabolic profiles to those of healthy controls. The research will involve a prospective, non-randomized, cross-sectional design, including 10 children with CP and 10 healthy children aged 2-18 years. Participants will undergo various assessments, including DXA scans and stable isotope infusions, to evaluate fat, glucose, and protein metabolism. The goal is to identify energy and protein needs to prevent complications associated with malnutrition and obesity in adulthood.
Why it matters
Potential benefit: If successful, this study could help define nutritional needs and improve health outcomes for children with cerebral palsy.
How similar studies have gone: While similar studies have explored metabolic profiles in children, this specific approach focusing on low muscle mass in CP is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.