Whole Body Metabolism in Children With Cerebral Palsy With Low Skeletal Muscle Mass
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Protein breakdown
Study Overview
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.
Detailed Description
Trial design and time frame:
A prospective, non-randomized, cross-sectional study.
There will be two different groups included:
- Children with cerebral palsy with low skeletal muscle mass
- Healthy controls: Children admitted to the hospital at the Epilepsy monitor unit (EMU for conditions not affecting metabolic function)
The trial will be conducted over a total of five days and takes place at the Copenhagen Neuromuscular Centre, Department of Neurology or Department of Pediatrics and Adolescent Medicine, Rigshospitalet
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Meal intervention with stable isotopes
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.
Intervention: Meal (Dietary Supplement)
Outcomes
Primary Outcomes
Protein breakdown
Time Frame: 10 hours
Phenylalanine Rate of appearance micro mol/kgFFM/min in a fasted and fed state
Secondary Outcomes
- Muscle biopsy(10 hours)
- Life quality score(10 hpurs)
- Quality of Skeletal Muscle(10 hours)
- Metabolities(10 hours)
- Hormones(10 hours)
- Energy utilization(10 hours)
- muscle biopsy(10 hours)
Investigators
Mette Cathrine Oerngreen
Principal Investigator
Rigshospitalet, Denmark