MalnutritionNCT06580093
Nutritional Status in Patients With Chronic Kidney Disease
An observational study of Malnutrition, run by Umeå University at 1 site in Sweden.
Trial summary
The goal of this observational study is to investigate how the GLIM criteria* for the diagnosis of malnutrition should be operationalized in patients with chronic kidney disease (CKD) treated with hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 69 participants
- Where
- 1 siteSweden
- Study dates
- 21 Aug 2024to Dec 2026
- 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: Patients with Chronic Kidney Disease (CKD) treated with hemodialysis at one university hospital in Sweden.
Who may be able to join
- age ≥18 years
- dialysis duration more than 3 months prior to recruitment
Who cannot join
- patients who only have a dialysis frequency of once a week
- patients treated with a combination of peritoneal dialysis and hemodialysis or treated at home
- patients were written consent cannot be obtained due to medical or mental illness or weakened state of health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Status and Nutritional Problems in Patients With Chronic Kidney Disease Treated With Hemodialysis
The goal of this observational study is to investigate how the GLIM criteria* for the diagnosis of malnutrition should be operationalized in patients with chronic kidney disease (CKD) treated with hemodialysis. The main questions it aims to answer are:
- How can malnutrition be defined when applying different combinations and operationalization strategies of the GLIM criteria?
- How can information from other nutrition assessment tools be used in the operationalization of GLIM?
- Which combinations and operationalization strategies of the GLIM criteria can best predict deterioration in quality of life, muscle strength, and increased mortality? This is an observational study on patients with CKD in hemodialysis. Variables are extracted from the Swedish renal registry, SNR and medical records at two hemodialysis units at one university hospital in Sweden. Data collection started in the fall of 2024, and are collected during two timepoints (baseline and follow-up) when wanted variables for this study are routinely measured at the units. Data on 2-year overall survival are also collected.
- The Global Leadership Initiative on Malnutrition (GLIM) criteria to diagnose malnutrition in adults
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Muscle mass, GLIM, chronic kidney disease
- Medical subject headings
- Malnutrition, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition diagnosis
Malnutition diagnosis according to GLIM
Measured: From Aug/Sept 2024 to May 2025
Secondary outcomes (4)
Muscle mass
Muscle mass according to Bioimpedance Spectroscopy and Calf circumference
Measured: From Aug/Sept 2024 to May 2025
Overall survival
Overall survival
Measured: From Aug/Sept 2024 to Dec 28
Muscle strength
Hand grip muscle strength
Measured: From Aug/Sept 2024 to May 2025
Health related quality of life
Health related quality of life according to RAND36
Measured: Aug/Sept 2024 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start21 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Sandra Einarsson, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580093
- Sponsor's protocol ID
- 2024-03363-01
- Other IDs
- 2022-06295
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status and Nutritional Problems in Patients With Chronic Kidney Disease Treated With Hemodialysis
- ClinicalTrials.gov ID
- NCT06580093
- Acronym / sponsor ID
- 2024-03363-01
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Muscle mass, GLIM, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Aug 2024 (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.
The goal of this observational study is to investigate how the GLIM criteria* for the diagnosis of malnutrition should be operationalized in patients with chronic kidney disease (CKD) treated with hemodialysis. The main questions it aims to answer are:
- How can malnutrition be defined when applying different combinations and operationalization strategies of the GLIM criteria?
- How can information from other nutrition assessment tools be used in the operationalization of GLIM?
- Which combinations and operationalization strategies of the GLIM criteria can best predict deterioration in quality of life, muscle strength, and increased mortality? This is an observational study on patients with CKD in hemodialysis. Variables are extracted from the Swedish renal registry, SNR and medical records at two hemodialysis units at one university hospital in Sweden. Data collection started in the fall of 2024, and are collected during two timepoints (baseline and follow-up) when wanted variables for this study are routinely measured at the units. Data on 2-year overall survival are also collected.
- The Global Leadership Initiative on Malnutrition (GLIM) criteria to diagnose malnutrition in adults
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Kidney Disease (CKD) treated with hemodialysis at one university hospital in Sweden.
Key inclusion criteria (2 listed)
- age ≥18 years
- dialysis duration more than 3 months prior to recruitment
Key exclusion criteria (3 listed)
- patients who only have a dialysis frequency of once a week
- patients treated with a combination of peritoneal dialysis and hemodialysis or treated at home
- patients were written consent cannot be obtained due to medical or mental illness or weakened state of health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Malnutrition diagnosis
Time frame: From Aug/Sept 2024 to May 2025
Malnutition diagnosis according to GLIM
4 secondary outcomes
Muscle mass
Time frame: From Aug/Sept 2024 to May 2025
Overall survival
Time frame: From Aug/Sept 2024 to Dec 28
Muscle strength
Time frame: From Aug/Sept 2024 to May 2025
Health related quality of life
Time frame: Aug/Sept 2024 (baseline)
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 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Sandra Einarsson, PhD principal investigator
Umeå University
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 Umeå University at 1 site in Sweden.
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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. 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 Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malnutrition diagnosis (time frame: From Aug/Sept 2024 to May 2025). 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 17 Jun 2026.