NCT06486597 Whole Body Metabolism in Children With Cerebral Palsy With Low Skeletal Muscle Mass
| NCT ID | NCT06486597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Cerebral Palsy (CP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-08-01 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT06486597 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06486597 currently recruiting?
Yes, NCT06486597 is actively recruiting participants. Visit ClinicalTrials.gov or contact Rigshospitalet, Denmark to inquire about joining.
Where is the NCT06486597 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06486597 clinical trial?
NCT06486597 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 20 participants.
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