Clinical trial NCT06164925: Standardising and Simplifying the Global Leadership Initiative on Malnutrition (GLIM) for Its More General Application
Official title: Standardising and Simplifying the Global Leadership Initiative on Malnutrition (GLIM) for Its More General Application
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition
Keywords: GLIM criteria
GLIM
nutrition assessment
nutrition screening
muscle mass
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: Tartu University Hospital
First posted: 2023-12-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients of day patients admitted to the Tartu University Hospital.

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Subjective Global Assessment (SGA) defined malnutrition
timeFrame: baseline, pre-intervention/procedure/surgery
measure: One-year mortality
timeFrame: through study completion, an average of 1 year
measure: Computed tomography (CT) defined muscle mass
timeFrame: baseline, pre-intervention/procedure/surgery
measure: DEXA defined muscle mass
timeFrame: baseline, pre-intervention/procedure/surgery
Secondary outcomes:
measure: Bioelectrical impedance (BIA) defined muscle mass
timeFrame: baseline, pre-intervention/procedure/surgery
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu Ülikooli Kliinikum
state: Tartumaa
Study officials:
affiliation: University of Tartu, Tartu University Hospital
name: Alastair Forbes, MD
role: PRINCIPAL_INVESTIGATOR
References: