Comparing Body Composition Assessment Methods

NCT04610918 | Completed

• 1 other identifier: 1000069821
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Improvement in clinical care has resulted in longer life expectancy of children with intestinal failure (IF). However, recent data indicate that their body composition (BC) is abnormal with a relatively high fat mass (FM) and low fat free mass (FFM). Abnormal BC is linked to poor prognosis and increased length of hospital stay; yet BC is not assessed in pediatric clinical practice. Instead, growth charts which lack sensitivity to detect changes in BC are used. Physical activity (PA) is the most important predictor of FFM and increased PA contributes to decreased FM. Decreased PA in childhood is associated with increased FM and decreased FFM which are linked to diabetes and cardiovascular disease in adulthood. Dual-energy X-ray Absorptiometry (DXA) is considered the reference method for measuring BC in the clinical setting but it is expensive and not suitable for routine use. Bioelectrical Impedance Analysis (BIA) on the other hand is relatively inexpensive and non-invasive but needs to be validated for use in patients with IF. Objectives: 1) validate BIA against DXA as a clinical tool for monitoring changes in BC in children with IF, 2) quantify PA levels using activity counts from accelerometers and 3) assess strength. Design: 1-18 years, with IF followed by the intestinal rehabilitation program at SickKids. All subjects receiving a DXA for routine clinical monitoring are eligible. BIA and muscle strength will be measured in clinic. Demographic data and IF related factors including height, weight, PN prescription, age, diagnosis, bowel length and length of time off PN for those who have achieved enteral autonomy will be obtained. DXA measurement will be done by Diagnostic Imaging at SickKids. Patients will be fitted with an accelerometer to be worn for 7 days. Statistics: Differences between sexes will be assessed by t test. Relationship between PA and BC, and BC and muscular strength will be assessed by linear regression analysis. Agreement between DXA and BIA will be assessed using a Bland-Altman test. Significance will be set at p\<0.05. Significance: This study has the potential to establish BIA as a convenient clinical tool to assess BC and provide a more accurate basis for nutritional and PA prescriptions to optimize long-term outcomes and quality of life in IF patients.

Conditions

Body Composition; Gastrointestinal Failure; Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• Body composition of children with intestinal failure compared with healthy controls.

  measurement of fat and fat-free mass by BIA and DXA

  11/1 2020 - 10/1/2023

Secondary Outcomes (1)

• To measure physical activity and strength of children with intestinal failure compared with healthy controls.

  11/1 2020 - 10/1/2023

Study Arms (2)

Cases - Pediatric Intestinal Failure Patients

DXA BIA Skin fold measurements Strength tests Physical activity monitoring

Controls

BIA Skin fold measurements Strength tests Physical activity monitoring

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Intestinal failure (IF) which is the inability of the gastrointestinal tract to absorb adequate fluid and nutrients for growth and maintenance due to disease associated loss of absorption.

You may qualify if:

• Participants with Intestinal Failure will be recruited from patients followed by our multidisciplinary intestinal rehabilitation program at SickKids. A total of about 133 patients are seen annually.
• Healthy controls will be age, race and sex matched. Age will be matched within ±2 months for subjects between 1-3 years and within ±6 month for those 4 years and above.
• Aged 1-18 years

You may not qualify if:

• patients who are wheelchair bound or non-weight bearing, those unwilling to participate.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Rare Disease Foundation: collaborator

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Yanchis D, So S, Patterson C, Belza C, Garofalo E, Wong-Sterling S, Silva C, Avitzur Y, Wales PW, Hulst JM, Kong D, Xu L, Li Y, Courtney-Martin G. Reduced strength is associated with abnormal body composition in children with a history of intestinal failure. J Pediatr Gastroenterol Nutr. 2025 Dec 9. doi: 10.1002/jpn3.70307. Online ahead of print.

  PMID: 41363022 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Glenda Courtney-Martin, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: November 2, 2020
• Study Start: October 20, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

CA (1)