Child DevelopmentNCT06121791
Abdominal Skeletal Muscle Compartments in Turkish Children
An observational study of Child Development and Sarcopenia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Child Development, Sarcopenia
- What is being tested?
- Normal values of abdominal level muscle areas of Turkish children
- How many people
- 2,168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: Healthy Turkish children
Who may be able to join
- No chronic disease
- Being under 18 years of age
- Being Turkish
- Determining that an abdominal CT was performed in the hospital records
Who cannot join
- Patients with malignancy or known chronic disease
- Patients with mental health problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Istanbul, 34173
About this study
Official title: Establishment Reference Values for Abdominal Skeletal Muscle Compartments in Turkish Children
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
Read the detailed description
The aim in this study is to determine reference values for Turkish children by evaluating the abdominal region skeletal muscle area (psoas muscle, paraspinal muscles and total skeletal muscle in the section) obtained from cross-sectional CT images.
Material Method of the Research The study was planned as a retrospective study. Patients under 18 years of age who are admitted to Istanbul Province Bağcılar Training and Research Hospital with acute abdominal pain or acute trauma between May 5, 2017 and May 5, 2023 and who underwent abdominal computed tomography (CT) imaging on this date of application will be scanned through the hospital information management system. Past diagnoses of these patients will be questioned and those with chronic diseases will be excluded from the study.
CT images of the patients will be retrieved from the PACS database. From the sections taken at the L3-L4, L4-L5 levels, the cross-sectional area of the psoas muscle, paraspinal muscles and the total skeletal muscles in that section will be measured using the hospital's SYNAPS system. The results will be recorded in cm2.
- Conditions
- Child Development, Sarcopenia
- Being tested
- Normal values of abdominal level muscle areas of Turkish children
- Keywords
- children, Abdominal Skeletal Muscle, Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
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.
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.
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.
Measured: 1 interview day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start25 Dec 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuğba Aydın, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- TUGBA AYDIN, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research HospitalEDA CINGOZ, Principal investigator, ISTANBUL BAĞCILAR TRAINING AND RESEARCH HOSPITAL RADIOLOGY UNIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121791
- Sponsor's protocol ID
- IstPMR-ct-mscl-chld
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36934494Harbaugh 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.
PubMed 28189451Metzger 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.
PubMed 33003166Lurz 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.
PubMed 31920002
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment Reference Values for Abdominal Skeletal Muscle Compartments in Turkish Children
- ClinicalTrials.gov ID
- NCT06121791
- Acronym / sponsor ID
- IstPMR-ct-mscl-chld
- Conditions
- Child Development, Sarcopenia
- Keywords
- children, Abdominal Skeletal Muscle, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,168 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The aim in this study is to determine reference values for Turkish children by evaluating the abdominal region skeletal muscle area (psoas muscle, paraspinal muscles and total skeletal muscle in the section) obtained from cross-sectional CT images.
Material Method of the Research The study was planned as a retrospective study. Patients under 18 years of age who are admitted to Istanbul Province Bağcılar Training and Research Hospital with acute abdominal pain or acute trauma between May 5, 2017 and May 5, 2023 and who underwent abdominal computed tomography (CT) imaging on this date of application will be scanned through the hospital information management system. Past diagnoses of these patients will be questioned and those with chronic diseases will be excluded from the study.
CT images of the patients will be retrieved from the PACS database. From the sections taken at the L3-L4, L4-L5 levels, the cross-sectional area of the psoas muscle, paraspinal muscles and the total skeletal muscles in that section will be measured using the hospital's SYNAPS system. The results will be recorded in cm2.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Healthy Turkish children
Key inclusion criteria (4 listed)
- No chronic disease
- Being under 18 years of age
- Being Turkish
- Determining that an abdominal CT was performed in the hospital records
Key exclusion criteria (2 listed)
- Patients with malignancy or known chronic disease
- Patients with mental health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal values of abdominal level muscle areas of Turkish childrenage, 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 | Other | – |
Primary outcome
L3-L4 LEVEL: Psoas muscle area
Time frame: 1 interview day
The Psoas muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.
L3-L4 LEVEL:Paraspinal muscle area
Time frame: 1 interview day
The Paraspinal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.
L3-L4 LEVEL: Abdominal muscle area,
Time frame: 1 interview day
The Abdominal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.
L4-L5 LEVEL: Psoas muscle area
Time frame: 1 interview day
The Psoas muscle area at the L4-L5 vertebra level in the patients' abdominal computed tomography will be measured.
L4-L5 LEVEL: Paraspinal muscle area
Time frame: 1 interview day
The Paraspinal muscle area at the L4-L5 vertebra level in the patients' abdominal computed tomography will be measured.
L4-L5 LEVEL: Abdominal muscle area,
Time frame: 1 interview day
The Abdominal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 36934494Kudo 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.
- Background: PubMed 28189451Harbaugh 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.
- Background: PubMed 33003166Metzger 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.
- Background: PubMed 31920002Lurz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUGBA AYDIN study chair
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
EDA CINGOZ principal investigator
ISTANBUL BAĞCILAR TRAINING AND RESEARCH HOSPITAL RADIOLOGY UNIT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development and Sarcopenia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L3-L4 LEVEL: Psoas muscle area (time frame: 1 interview day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06121791, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.