Investigating metabolism in children with cerebral palsy and low muscle mass
Whole Body Metabolism in Children With Cerebral Palsy With Low Skeletal Muscle Mass
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen, Copenhagen Ø) |
| Trial ID | NCT06486597 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children aged 2-18 years with cerebral palsy who are wheelchair dependent and have low skeletal muscle mass.
Not a fit: Patients with competing conditions that may compromise study results or those unable to cooperate with the study procedures may not benefit.
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 performed: While similar studies have explored metabolic profiles in children, this specific approach focusing on low muscle mass in CP is relatively novel.
Eligibility criteria
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 this trial is running
Copenhagen, Copenhagen Ø
- Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet — Copenhagen, Copenhagen Ø, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.