Actively Recruiting

Phase Not Applicable
Age: 2Years - 18Years
All Genders
Healthy Volunteers
NCT06486597

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

Led by Rigshospitalet, Denmark · Updated on 2025-02-26

20

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with cerebral palsy with low skeletal muscle mass who are wheelchair dependent (GMFCS IV-V)
  • Healthy controls are children admitted to the Epilepsy Monitor Unit (EMU) for epilepsy classification, ruling out epilepsy, or nocturnal EEG changes
  • Age between 2 and 18 years
  • Signed informed consent to participate in the trial
Not Eligible

You will not qualify if you...

  • Inability of the child or parents/guardians to understand the trial purpose or cooperate with study procedures
  • Presence of other medical conditions that could affect study results
  • For healthy controls, concerns that participation may affect the diagnostic quality of EMU investigations
  • Participation in other clinical trials that could interfere with this study's results
  • Use of medications that may affect study outcomes, as determined by the investigator
  • Pregnancy or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, Copenhagen Ø, Denmark, 2100

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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