MalnutritionNCT06164925
Standardising and Simplifying the Global Leadership Initiative on Malnutrition (GLIM) for Its More General Application
An observational study of Malnutrition, run by University of Tartu at 1 site in Estonia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutrition screening and assessment
- How many people
- 300 participants
- Where
- 1 siteEstonia
- Study dates
- 13 Dec 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients of day patients admitted to the Tartu University Hospital.
Who may be able to join
- Age of 18+ years
- Able and willing to sign the consent form
- Inpatients of the Tartu University Hospital
- Admitted within 72 hours before enrolment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alastair Forbes, MD contact
Estonia1 site, 1 recruiting
- Recruiting
Tartu Ülikooli Kliinikum
Tartu, Tartu, 50406
Alastair Forbes, MD, +372 58830422, 2020aforbes@gmail.com
Grete Kurik, BSc, +372 53436535, grete.kurik@ut.ee
About this study
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.
Read the 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).
- Conditions
- Malnutrition
- Being tested
- Nutrition screening and assessment
- Keywords
- GLIM criteria, GLIM, nutrition assessment, nutrition screening, muscle mass
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition screening and assessmentDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Nutrition screening and assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, pre-intervention/procedure/surgery
Secondary outcomes (1)
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.
Measured: baseline, pre-intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start13 Dec 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Tartu University Hospital
- Responsible party
- Principal investigator, Alastair Forbes, University of Tartu
- Investigators
- Alastair Forbes, MD, Principal investigator, University of Tartu, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164925
- Sponsor's protocol ID
- 23092
- Status last verified
- Feb 2025
- First submitted
- 1 Nov 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardising and Simplifying the Global Leadership Initiative on Malnutrition (GLIM) for Its More General Application
- ClinicalTrials.gov ID
- NCT06164925
- Acronym / sponsor ID
- 23092
- Conditions
- Malnutrition
- Keywords
- GLIM criteria, GLIM, nutrition assessment, nutrition screening, muscle mass
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Tartu University Hospital
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients of the Tartu University Hospital | – | Diagnostic Test: Nutrition screening and assessmentInclusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients of day patients admitted to the Tartu University Hospital.
Key inclusion criteria (4 listed)
- Age of 18+ years
- Able and willing to sign the consent form
- Inpatients of the Tartu University Hospital
- Admitted within 72 hours before enrolment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition screening and assessmentThe 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. | Diagnostic test | Inpatients of the Tartu University Hospital |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Bioelectrical impedance (BIA) defined muscle mass
Time frame: baseline, pre-intervention/procedure/surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alastair Forbes, MD contact
Alastair Forbes, MD principal investigator
University of Tartu, Tartu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grete Kurik, BSc (+372 53436535, grete.kurik@ut.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Global Assessment (SGA) defined malnutrition (time frame: baseline, pre-intervention/procedure/surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.