Effect of Malnutrition on Liver and Spleen Stiffness in Children (SWE)

April 10, 2025 updated by: Mehmet Akif AĞIR

Impact of Malnutrition on Liver and Spleen Stiffness in Children Evaluated by Shear Wave Elastography

This prospective observational study aims to evaluate the effect of malnutrition on liver and spleen stiffness in children using shear wave elastography. Two groups of participants will be enrolled: children diagnosed with malnutrition and age-matched healthy controls. Organ stiffness measurements will be compared between the two groups to assess the impact of malnutrition on liver and spleen tissue properties.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study designed to investigate the effect of malnutrition on liver and spleen stiffness in children. The study will include two groups: children diagnosed with malnutrition according to WHO criteria, and age- and sex-matched healthy controls without any known chronic illness.

All participants will undergo shear wave elastography (SWE) to measure liver and spleen stiffness using standardized ultrasound protocols. Measurements will be performed by a pediatric radiologist blinded to the nutritional status of the participants.

The primary objective is to compare organ stiffness values between malnourished children and healthy controls. Secondary analyses will explore correlations between severity of malnutrition and stiffness values. The study aims to provide non-invasive insights into early organ-level changes associated with pediatric malnutrition.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Konya, Turkey, 42130
        • Recruiting
        • Selçuk University Faculty of Medicine
        • Contact:
        • Contact:
          • Mehmet Akif AGIR, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will include children aged 6 to 18 years, divided into two groups:

  1. Malnutrition group: Children diagnosed with malnutrition according to World Health Organization (WHO) criteria.
  2. Healthy control group: Age- and sex-matched healthy children with no known chronic illnesses.

Both groups will undergo shear wave elastography to measure liver and spleen stiffness.

Description

Inclusion Criteria:

  • Children aged 6 to 18 years.
  • Diagnosis of malnutrition based on World Health Organization (WHO) criteria (for malnutrition group).
  • Healthy children without any chronic illness (for control group).

Exclusion Criteria:

  • Children with chronic diseases (e.g., liver disease, diabetes, immunocompromised conditions).
  • Children who have previously undergone liver or spleen surgery.
  • Children with inability to cooperate during elastography measurement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Malnutrition Group
Children diagnosed with malnutrition based on World Health Organization (WHO) criteria. Participants in this group will undergo shear wave elastography to evaluate liver and spleen stiffness.
Diagnostic test: Shear Wave Elastography
Shear wave elastography will be used to measure liver and spleen stiffness in all participants. The procedure will be performed using standard ultrasound-based elastography protocols by a pediatric radiologist.
Other Names:
  • SWE
Healthy Control Group
Age- and sex-matched healthy children with no known chronic diseases. These participants will also undergo shear wave elastography to allow comparison of organ stiffness values with the malnutrition group.
Diagnostic test: Shear Wave Elastography
Shear wave elastography will be used to measure liver and spleen stiffness in all participants. The procedure will be performed using standard ultrasound-based elastography protocols by a pediatric radiologist.
Other Names:
  • SWE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver stiffness value (kPa)
Time Frame: At baseline (single time point assessment)
Liver stiffness will be measured in kilopascals (kPa) using shear wave elastography. The average of three valid measurements will be recorded for each participant.
At baseline (single time point assessment)
Spleen stiffness value (kPa)
Time Frame: At baseline
Spleen stiffness will be measured in kilopascals (kPa) using shear wave elastography. Similar to liver, the average of three valid measurements will be used.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mehmet Akif AĞIR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

May 20, 2025

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual participant data will be shared upon request with qualified researchers, subject to institutional review and approval. Data sharing will be conducted in accordance with the university's data protection policies.

IPD Sharing Time Frame

January 2026-January 2028

IPD Sharing Access Criteria

The individual participant data (IPD) will be accessible to qualified researchers upon request. Access will be granted following the approval of the Institutional Review Board (IRB) or relevant ethics committee. Researchers will be provided with access to de-identified data, including liver and spleen stiffness measurements, to ensure participant privacy. Access will be granted through a secure data-sharing platform or through direct data transfer from the research team. Data access will be subject to the terms and conditions of the institution's data-sharing policy.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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