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

NCT06486597 | Recruiting

• 1 other identifier: 22-B01-1066
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (1)

• Protein breakdown

  Phenylalanine Rate of appearance micro mol/kgFFM/min in a fasted and fed state

  10 hours

Secondary Outcomes (11)

• Muscle biopsy

  10 hours

• Life quality score

  10 hpurs

• Quality of Skeletal Muscle

  10 hours

• Metabolities

  10 hours

• Hormones

  10 hours

Study Arms (1)

Meal intervention with stable isotopes

EXPERIMENTAL

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.

Dietary Supplement: Meal

Interventions

Meal DIETARY_SUPPLEMENT

Liquid meal

Meal intervention with stable isotopes

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

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

Copenhagen, Copenhagen Ø, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Meals

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

DK (1)