Impact of Undernutrition Definitions on Its Prevalence in Hospitalized Patients

NCT05309759 | Recruiting DMC

• 1 other identifier: 2021-A02410-41
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

In France, the prevalence of undernutrition among hospitalized patients varies from 30 to 50%. Undernutrition is strongly associated with a decrease in the patient's functional capacities and an increase in morbidity and mortality and in healthcare costs. In 2019, the Global Leadership Initiative on Malnutrition (GLIM) and the Haute Autorité de Santé (HAS) are each publishing updated diagnostic criteria for undernutrition in adults aged \<70 years. Aetiological and phenotypic criteria are retained: reduced food intake, inflammatory state, weight loss, BMI and reduced muscle mass. Reduced muscle mass has become a major diagnostic criterion and various measurement tools are suggested, such as bioelectrical impedancemetry, grip strength measurement or magnetic resonance imaging. Collaboration between dieticians, physiotherapists, nurses, care assistants and doctors makes it possible to respond to the need to screen for undernutrition according to these new definitions, which involve a multidisciplinary assessment. These two definitions are very similar but differ on the time period of weight loss, on the BMI cut-off values and on the thresholds for muscle mass loss. The GLIM definition may be less selective than the HAS definition. The investigators hypothesise that the prevalence of undernutrition in a population of adult patients hospitalised in diabetology-obesity, pneumology, oncology and gastro-nutrition, aged \< 70 years, is different according to the diagnostic criteria recommended by the HAS or by the GLIM, and may be associated with a different patient morbi-mortality. In addition, the choice of the method of assessment of muscle function could impact this prevalence. The main objective of this study is to compare the prevalence of global undernutrition based on the diagnostic criteria recommended by the HAS with that based on the diagnostic criteria recommended by the GLIM, in patients hospitalised in diabetes-obesity, pneumology, oncology and gastro-nutrition units. The secondary objectives will be, in patients hospitalized in diabetes-obesity, pneumology, oncology and gastro-nutrition units:

• To compare the prevalence of severe undernutrition between the HAS and GLIM groups;
• To compare the morbi-mortality of undernutrition between the HAS and GLIM groups on :
• Length of hospital stay ;
• Mortality rate;
• Autonomy at discharge.
• To evaluate the impact of the choice of the muscle function assessment tool on the prevalence of undernutrition in the HAS and GLIM groups. This is a prospective, monocenter, observationnal and cohort study. Patients hospitalised in acute and rehabilitation care for diabetes-obesity, pneumology, oncology and gastro-nutrition purpose. Univariate comparisons will use the usual statistical tests after verification of the distribution of the variables (Chi2 or Fisher's test, t-test, anova or their non-parametric equivalents Wilcoxon and Kruskal-Wallis tests). The variables will be compared between the two groups by the appropriate tests according to the type of variables (quantitative or qualitative) and their distribution. The results of this study will make it possible to verify whether the GLIM definition increases the prevalence of undernutrition compared to that of the HAS. The use of one or other of the definitions could thus have an impact on the medical and paramedical management of undernutrition. On the other hand, muscle function benefits from different assessment tools, which could lead to a different estimate of the reduction in muscle mass and therefore a different prevalence of undernutrition. The results of our study will help to evaluate this and guide professionals in the choice of tools for assessing muscle function.

Conditions

Undernutrition

Keywords

undernutrition; muscle assessment; diagnostic

Outcome Measures

Primary Outcomes (1)

• Prevalence of global undernutrition

  The main outcome is the prevalence of global undernutrition in patients hospitalised in diabetes-obesity, pneumology, oncology and gastro-nutrition departments, according to the diagnostic methods of the HAS and GLIM.

  Through study completion, an average of 20 months

Secondary Outcomes (7)

• Prevalences of severe undernutrition

  Through study completion, an average of 20 months

• Duration of hospital stay

  Through study completion, an average of 20 months

• Mortality

  Through study completion, an average of 20 months

• Autonomy at discharge

  Through study completion, an average of 20 months

• Bioelectrical impedance measurement

  Through study completion, an average of 20 months

Eligibility Criteria

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

Study Population

Patients will be recruited prospectively and consecutively from the departments of diabetes-obesity, pneumology, oncology and gastro-nutrition at the Forcilles Hospital. The dietician of the unit identifies the patients on admission to the department.

You may qualify if:

• Admitted to diabetes-obesity, pneumology, oncology and gastro-nutrition departments;
• Affiliation with a social security scheme or beneficiary of such a scheme ;
• Oral, free, informed and express consent of the patient.

You may not qualify if:

• Inability to perform bioelectrical impedance measurement ;
• Incapacity to consent ;
• Patient's refusal to participate in the study ;
• Known pregnancy ;
• Person subject to a legal protection measure ;
• Patient under guardianship or curatorship ;
• Patient with limited care ;
• Randomisation in the ineligible study group.

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (1)

Hôpital Forcilles

Férolles-Attilly, 77150, France

RECRUITING

Related Publications (3)

• Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, 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. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.

  PMID: 30181091 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

• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

  PMID: 20392703 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Virginie COLELLA, MSc

  Hopital Forcilles

  PRINCIPAL INVESTIGATOR

• Ilham BENHARRATS, MD

  Hopital Forcilles

  STUDY DIRECTOR

• Aymeric LE NEINDRE, PhD

  Hopital Forcilles

  STUDY CHAIR

Central Study Contacts

Aymeric Le Neindre, PhD

CONTACT

+33160646093; aleneindre@cognacq-jay.fr

Andreia GOMES LOPES, MSc

CONTACT

+33160646093; alopes@cognacq-jay.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: February 10, 2022
• Primary Completion: October 10, 2025
• Study Completion: December 10, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

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)