NCT06121791

Brief Summary

The aim of this study was to establish reference values for three compartments of the abdominal skeletal muscle area (psoas muscle area, paraspinal muscle area, and total skeletal muscle area) obtained from cross-sectional Computed tomography images in Turkish Children

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,168

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 25, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

November 2, 2023

Last Update Submit

November 18, 2024

Conditions

Child DevelopmentSarcopenia

Keywords

childrenAbdominal Skeletal MuscleSarcopenia

Outcome Measures

Primary Outcomes (6)

  • L3-L4 LEVEL: Psoas muscle area

    The Psoas muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.

    1 interview day

  • L3-L4 LEVEL:Paraspinal muscle area

    The Paraspinal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.

    1 interview day

  • L3-L4 LEVEL: Abdominal muscle area,

    The Abdominal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.

    1 interview day

  • L4-L5 LEVEL: Psoas muscle area

    The Psoas muscle area at the L4-L5 vertebra level in the patients' abdominal computed tomography will be measured.

    1 interview day

  • L4-L5 LEVEL: Paraspinal muscle area

    The Paraspinal muscle area at the L4-L5 vertebra level in the patients' abdominal computed tomography will be measured.

    1 interview day

  • L4-L5 LEVEL: Abdominal muscle area,

    The Abdominal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.

    1 interview day

Interventions

Normal values of abdominal level muscle areas of Turkish childrenOTHER

age, sex, L3-L4 LEVEL: Psoas muscle area, Paraspinal muscle area, Abdominal muscle area, L4-L5 LEVEL: Psoas muscle area, Paraspinal muscle area, Abdominal muscle area

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Turkish children

You may qualify if:

  • No chronic disease
  • Being under 18 years of age
  • Being Turkish
  • Determining that an abdominal CT was performed in the hospital records

You may not qualify if:

  • Patients with malignancy or known chronic disease
  • Patients with mental health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, 34173, Turkey (Türkiye)

Location

Related Publications (4)

  • Kudo W, Terui K, Hattori S, Takenouchi A, Komatsu S, Oita S, Sato Y, Hishiki T. Establishment and validation of reference values for abdominal skeletal muscle compartments in children. Clin Nutr. 2023 May;42(5):653-660. doi: 10.1016/j.clnu.2023.02.022. Epub 2023 Mar 2.

    PMID: 36934494BACKGROUND

  • Harbaugh CM, Zhang P, Henderson B, Derstine BA, Holcombe SA, Wang SC, Kohoyda-Inglis C, Ehrlich PF. Personalized medicine: Enhancing our understanding of pediatric growth with analytic morphomics. J Pediatr Surg. 2017 May;52(5):837-842. doi: 10.1016/j.jpedsurg.2017.01.030. Epub 2017 Jan 29.

    PMID: 28189451BACKGROUND

  • Metzger GA, Sebastiao YV, Carsel AC, Nishimura L, Fisher JG, Deans KJ, Minneci PC. Establishing Reference Values for Lean Muscle Mass in the Pediatric Patient. J Pediatr Gastroenterol Nutr. 2021 Feb 1;72(2):316-323. doi: 10.1097/MPG.0000000000002958.

    PMID: 33003166BACKGROUND

  • Lurz E, Patel H, Lebovic G, Quammie C, Woolfson JP, Perez M, Ricciuto A, Wales PW, Kamath BM, Chavhan GB, Juni P, Ng VL. Paediatric reference values for total psoas muscle area. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):405-414. doi: 10.1002/jcsm.12514. Epub 2020 Jan 9.

    PMID: 31920002BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • TUGBA AYDIN

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    STUDY CHAIR

  • EDA CINGOZ

    ISTANBUL BAĞCILAR TRAINING AND RESEARCH HOSPITAL RADIOLOGY UNIT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, Assoc Prof

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 8, 2023

Study Start

December 25, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)