Standardising and Simplifying the Global Leadership Initiative on Malnutrition (GLIM) for Its More General Application

Malnutrition Clinical Trial

Official title:

Standardising and Simplifying the Global Leadership Initiative on Malnutrition (GLIM) for Its More General Application

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164925
• Other study ID #: 23092
• Status: Recruiting
• Start date: December 13, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: December 2023
• Source: University of Tartu
• Contact: Grete Kurik, BSc
• Phone: +372 53436535
• Email: grete.kurik[@]ut.ee
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study of aims to test whether and how the results of GLIM change when using different approaches and methods to carry out its components.

Description:

The main questions the study aims to answer are: - What is the most effective pre-GLIM screening approach? - Which of the simple, globally accessible muscle mass measurement methods works the best in the context of GLIM? - How does using simpler approaches to screening and muscle mass measurement affect the performance of GLIM in detecting Subjective Global Assessment (SGA) defined malnutrition and 1-year mortality? Participants will be/have: - asked questions about their recent food intake and possible non-volitional weight loss - assessed for malnutrition with SGA - weighed, and their height will be measured (if not already recorded) - their muscle mass measured with a measuring tape (mid-upper arm circumference and calf circumference) and bioelectrical impedance - their muscle function measured using hand grip strength - have their patient records looked at to extract their weight and height data (if present), diagnoses, routine blood test results, abdominal computed tomography (CT) scan (if present), dual-energy x-ray absorptiometry (DEXA) scan (if present), 1-year mortality and personal identification code for documentation (the latter will be deleted when the study period is over).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of 18+ years
• Able and willing to sign the consent form
• Inpatients of the Tartu University Hospital
• Admitted within 72 hours before enrolment

Exclusion Criteria:

• Age of <18 years
• Inability or refusal to sign the consent form
• Pregnant or lactating women
• More than 72 hours passed since admission
• Patients isolating with an infection

Related Conditions & MeSH terms

• Malnutrition

Intervention

Diagnostic Test:
• Nutrition screening and assessment
The patient is interviewed for changes in body weight in the last six months and food intake in the last two weeks. The investigator evaluates the patient's diet, symptoms related to their nutritional status, and functional capacity according to the Subjective Global Assessment (SGA). The SGA tool itself is completed by the researcher. Height and weight of the patient are measured, if not yet recorded, and BMI is calculated. The patient's muscle mass is measured using mid-upper arm circumference (MUAC), calf circumference (CC) and bioelectrical impedance (BIA), and their muscle function assessed using hand grip strength.

Locations

Country	Name	City	State
Estonia	Tartu Ülikooli Kliinikum	Tartu	Tartumaa

Sponsors (2)

Lead Sponsor	Collaborator
University of Tartu	Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Global Assessment (SGA) defined malnutrition	Subjective Global Assessment (SGA) can be considered a method that is close to a "gold standard" for malnutrition assessment. Therefore, the study will analyse how different approaches to screening and muscle mass measurement affect the performance of GLIM in detecting Subjective Global Assessment (SGA) defined malnutrition.	baseline, pre-intervention/procedure/surgery
Primary	One-year mortality	One year after the data collection, we will look at the patient records to collect the 1-year mortality data. This will give information about whether and how different approaches to components of GLIM affect its ability to predict one-year mortality.	through study completion, an average of 1 year
Primary	Computed tomography (CT) defined muscle mass	One of the GLIM criteria is "reduced muscle mass", and this study will investigate how muscle mass measured with simpler methods compares against muscle mass measured with CT.	baseline, pre-intervention/procedure/surgery
Primary	DEXA defined muscle mass	One of the GLIM criteria is "reduced muscle mass", and this study will investigate how muscle mass measured with simpler methods compares against muscle mass measured with DEXA.	baseline, pre-intervention/procedure/surgery
Secondary	Bioelectrical impedance (BIA) defined muscle mass	One of the GLIM criteria is "reduced muscle mass", and this study will investigate how muscle mass measured with simpler methods compares against muscle mass measured with BIA.	baseline, pre-intervention/procedure/surgery