- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06164925
Standardising and Simplifying the Global Leadership Initiative on Malnutrition (GLIM) for Its More General Application
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Grete Kurik, BSc
- Phone Number: +372 53436535
- Email: grete.kurik@ut.ee
Study Contact Backup
- Name: Alastair Forbes, MD
- Email: alastair.forbes@ut.ee
Study Locations
-
-
Tartumaa
-
Tartu, Tartumaa, Estonia, 50406
- Recruiting
- Tartu Ulikooli Kliinikum
-
Contact:
- Grete Kurik, BSc
- Phone Number: +372 53436535
- Email: grete.kurik@ut.ee
-
Contact:
- Alastair Forbes, MD
- Phone Number: +372 58830422
- Email: 2020aforbes@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Alastair Forbes, MD, University of Tartu, Tartu University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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