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

March 24, 2025 updated by: Alastair Forbes, University of Tartu
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.

Study Overview

Status

Recruiting

Conditions

Detailed 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).

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 Contact Backup

Study Locations

    • Tartumaa
      • Tartu, Tartumaa, Estonia, 50406
        • Recruiting
        • Tartu Ulikooli Kliinikum
        • Contact:
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inpatients of day patients admitted to the Tartu University Hospital.

Description

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

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
Inpatients of the Tartu University Hospital

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Global Assessment (SGA) defined malnutrition
Time Frame: baseline, pre-intervention/procedure/surgery
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
One-year mortality
Time Frame: through study completion, an average of 1 year
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
Computed tomography (CT) defined muscle mass
Time Frame: baseline, pre-intervention/procedure/surgery
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
DEXA defined muscle mass
Time Frame: baseline, pre-intervention/procedure/surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioelectrical impedance (BIA) defined muscle mass
Time Frame: baseline, pre-intervention/procedure/surgery
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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Alastair Forbes, MD, University of Tartu, Tartu University Hospital

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)

December 13, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23092

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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