Evaluation of the Validity and Reliability of Muscle Ultrasound in the Detection of Undernutrition

NCT05831592 | Completed DMC

• 1 other identifier: 2022-A00581-42
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

In France, the prevalence of undernutrition in hospitalized patients varies from 30 to 50%. Undernutrition is strongly associated with a decrease in the patient's functional abilities and an increase in morbidity and mortality and healthcare expenses. In 2019, the Global Leadership Initiative on Malnutrition (GLIM) published an international consensus report on diagnostic criteria for undernutrition. The diagnostic criteria are numerous, and include etiological criteria such as reduced food intake; an inflammatory setting; symptoms such as anorexia, fatigue; phenotypic criteria such as weight loss, body mass index (BMI), fat to lean mass ratio, fluid retention, and muscle function. Muscle mass is described as a major diagnostic criterion, since it is on the one hand a direct indicator of protein catabolism related to undernutrition, but also a reflection of functional impairment in the patient, as it is directly associated with functional capacities, autonomy and prognosis. Ultrasound is a reproducible method of muscle assessment. It allows the evaluation of muscle thickness or cross-sectional area of a muscle, the reduction of which, a marker of atrophy, is strongly correlated to its loss of strength and to reference measurements. In addition, ultrasound can be used to assess muscle quality, particularly by evaluating the echogenicity of the muscle. The echogenicity increases when the muscle is altered, linked to the presence of fatty infiltrate and fibrous tissue. The use of ultrasound in the evaluation of the patient's nutritional status, as a tool for assessing muscle function, is developing in the ICU and is associated with an increase in the patient's comorbidities. Studies remain limited to a few patient populations, do not report clear cut-off values to define muscle pathological status, and require more precise definition of ultrasound measurement protocols. The investigators hypothesize that muscle ultrasound is reliable and valid in the evaluation of muscle function during the screening of undernutrition in a population of patients hospitalized in diabetology-obesity, pneumology, oncology and gastro-nutrition, under 70 years old.

Conditions

Undernutrition

Keywords

undernutrition; muscle ultrasound; diagnostic

Outcome Measures

Primary Outcomes (1)

• Reduction in muscle mass measured by ultrasound thickness of the rectus femoris.

  The primary endpoint is the reduction in muscle mass measured by ultrasound thickness of the rectus femoris. The reduction in muscle mass measured by ultrasound will be used to estimate the diagnostic accuracy of muscle ultrasound using bioelectrical impedancemetry as the reference examination.

  Through study completion, an average of 2 years

Secondary Outcomes (3)

• Correlation measurements of muscle ultrasound with:

  Through study completion, an average of 2 years

• Comparison of the diagnostic accuracy in undernutrition of muscle ultrasound with those of :

  Through study completion, an average of 2 years

• Measure of association of muscle ultrasound measurements with patient morbi- mortality:

  Through study completion, an average of 2 years

Study Arms (1)

Diagnostic accuracy of muscle ultrasound in undernutrition

OTHER

All included patients will undergo an muscle ultrasound assessment in undernutrition

Diagnostic Test: Muscle ultrasound

Interventions

Muscle ultrasound DIAGNOSTIC_TEST

Muscle ultrasound assessment (sensitivity, specificity) in undernutrition in patients

Diagnostic accuracy of muscle ultrasound in undernutrition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted in short stay and follow-up care and rehabilitation of diabetology-obesity, pneumology, oncology and gastro-nutrition;
• Affiliation with a social security system or beneficiary of such a system ;
• Oral, free, informed and express consent of the patient or his/her family member.

You may not qualify if:

• Impossible to perform the ultrasound;
• Impossibility of performing bioelectrical impedancemetry ;
• Incapacity to consent;
• Patient refusal to participate in the study;
• Pregnancy (a pregnancy test should be performed if in doubt);
• Breastfeeding woman;
• Person subject to a safeguard of justice measure ;
• Patient under guardianship or curatorship;
• Patient in care limitation;
• Sampling in the ineligible study group.

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (1)

Hôpital Forcilles

Férolles-Attilly, Île-de-France Region, 77150, France

Location

Related Publications (4)

• Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats AJS, Crivelli AN, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee, GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):207-217. doi: 10.1002/jcsm.12383.

  PMID: 30920778 BACKGROUND

• Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9. doi: 10.1016/s0261-5614(02)00215-7.

  PMID: 12765661 BACKGROUND

• Biolo G, Cederholm T, Muscaritoli M. Muscle contractile and metabolic dysfunction is a common feature of sarcopenia of aging and chronic diseases: from sarcopenic obesity to cachexia. Clin Nutr. 2014 Oct;33(5):737-48. doi: 10.1016/j.clnu.2014.03.007. Epub 2014 Mar 29.

  PMID: 24785098 BACKGROUND

• Nijholt W, Scafoglieri A, Jager-Wittenaar H, Hobbelen JSM, van der Schans CP. The reliability and validity of ultrasound to quantify muscles in older adults: a systematic review. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):702-712. doi: 10.1002/jcsm.12210. Epub 2017 Jul 12.

  PMID: 28703496 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Disease

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aymeric LE NEINDRE, PhD

  Hopital Forcilles

  PRINCIPAL INVESTIGATOR

• Virginie COLELLA, MSc

  Hopital Forcilles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective interventional study

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 26, 2023
• Study Start: February 23, 2023
• Primary Completion: January 25, 2025
• Study Completion: March 10, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: At publication for 10 years
• Access Criteria: The data that support the findings of this study will be available from the corresponding author upon reasonable request.

Locations

FR (1)