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

Key facts

Who runs it
Copenhagen University Hospital, Rigshospitalet
Where
Denmark1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
20 people, planned
Started
1 Aug 2023
Expected to end
31 Jul 2028
Type of study
Interventional
Treatments tested
  • Meal
Record updated
26 February 2025

Who can take part

Age
2 years to 18 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • -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

Who cannot take part

  • Intake of medications that may interfere with the results, evaluated by investigator
  • Competing conditions at risk of compromising the results of the study
  • 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
  • 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
  • Pregnancy or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 18 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Meal intervention with stable isotopesTreatment being tested

    A liquid mixed meal are gived adjusted by weight. The meal consists of: Intrinsically labelled D5-Phenylalanine and D3-Leucine labelled casein protein, 13C16palmitate, 13C6-Glucose in a mix of glucose, casein protein and rape seed oil dissolved in water in an energy density of 50% CHO, 35% fat and 15% protein. Blood samples are drawn frequently to measure fat, glucose and protein metabolism.

    Treatment: Meal

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT06486597, who can take part
Record updated
26 February 2025