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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06164925
Other study ID # 23092
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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