Whole Body Metabolism in Children With Cerebral Palsy With Low Skeletal Muscle Mass
NCT Number: NCT06486597
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy (CP)
Interventions: DIETARY_SUPPLEMENT: Meal
Sponsor: Rigshospitalet, Denmark
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-08-01
Completion Date: 2028-07-31
Locations: Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen, Copenhagen Ø, 2100, Denmark

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.

Primary Outcome Measures: Protein breakdown, Phenylalanine Rate of appearance micro mol/kgFFM/min in a fasted and fed state, 10 hours
Secondary Outcome Measures: Muscle biopsy, Muscle morphology, 10 hours|Life quality score, Life quality score by using Pediatric Quality of Life Inventory (PedsQL) (0-100), high score indicates worse qualiity of life., 10 hpurs|Quality of Skeletal Muscle, Dual-energy X-ray absorptiometry (DEXA) scan, 10 hours|Metabolities, Concentration of plasma amino acids (mmol/L), concentration of glucose (mmol/L), concentration of palmitate (micromol/L), concentration of free fatty acids (mmol/L) and levels of HbA1c (mmol/mol), 10 hours|Hormones, Concentration of Insulin (pmol/L), concentration of catecholamines (nmol/l) , glucagon (pmol/L), gut hormones and incretins (GLP-1 (pmol/L) and GIP, (pmol/L)), 10 hours|Energy utilization, Energy expenditure assessed by doubly labeled water method and 13C breath test to test that these methods are valuable and can be used in the future as less expensive and invasive methods to measure energy utilization., 10 hours|Muscle biopsy, muscle fiber type, 10 hours|muscle biopsy, size, 10 hours|Muscle biopsy, Protein markers (MuRF1, MAFbx, FoxO), 10 hours|Muscle biopsy, muscle generating markers (Myo D, Myogenin, IGF1), 10 hours|Muscle biopsy, Muscle growth regulating protein (myostatin), 10 hours