NCT06164925

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

December 13, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 28, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

November 1, 2023

Last Update Submit

March 24, 2025

Conditions

Keywords

GLIM criteriaGLIMnutrition assessmentnutrition screeningmuscle mass

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Bioelectrical impedance (BIA) defined muscle mass

    baseline, pre-intervention/procedure/surgery

Study Arms (1)

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.

Diagnostic Test: Nutrition screening and assessment

Interventions

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.

Inpatients of the Tartu University Hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients of day patients admitted to the Tartu University Hospital.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu Ülikooli Kliinikum

Tartu, Tartu, 50406, Estonia

RECRUITING

MeSH Terms

Conditions

Malnutrition

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Alastair Forbes, MD

    University of Tartu, Tartu University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grete Kurik, BSc

CONTACT

Alastair Forbes, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Professor

Study Record Dates

First Submitted

November 1, 2023

First Posted

December 11, 2023

Study Start

December 13, 2023

Primary Completion

March 31, 2025

Study Completion

June 30, 2025

Last Updated

March 28, 2025

Record last verified: 2025-02

Locations