RecruitingNot Applicable

Methods for Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients

Denmark500 participantsStarted 2026-03-01

Plain-language summary

The goal of this observational study, is to improve the diagnostic assessment method of malnutrition and kidney diseases, amongst hospitalized and low priority patients, by evaluating modern methodology and biomarkers, with regards to an estimate of the nutritional status and kidney diseases, against current gold standards, and also investigate how body composition, hydration, inflammation and age affect the assessments.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 65 years or older (group 1, 4 and 5) * 90 years or older (group 3) * Acute admission (group 1, 2) * Cognitively able to cooperate (group 1) * Able to read and speak Danish (group 1, 2, 3, 4, 5, 6) * BMI ≥ 35 kg/m2 (group 4) * Prednisolon treatment for COPD (≥ 37,5 mg daily) (group 5) * Amputation(s) of crus or femur (non-traumatic) (group 6) Exclusion Criteria: * Isolation (group 1, 2, 3, 4, 5, 6) * Terminal treatment (group 1, 2, 3, 4, 5, 6) * Suicidal (group 1, 2, 3, 4, 5, 6) * Active Immune suppressing treatment (group 2, 3, 4, 5, 6) * Oedemas (group 2, 3, 4, 5, 6) * In active treatment for cancer (group 2, 3, 4, 5, 6)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To investigate whether the method used to determine body composition affects the diagnosis of malnutrition when applying the GLIM criteria.

Timeframe: Time of inclusion and/or 14 days after preliminary inclusion.

To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS in acutely hospitalized patients with a cystatin C/kreatinin ratio <0,7 (patients from groups 1 and 2)

Timeframe: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)

To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS in patients aged ≥90 år (patients from groups 1 and 3)

Timeframe: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)

To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS in patients with BMI ≥35 kg/m2 (patients from groups 1 and 4)

Timeframe: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)

To determine changes in mGFRDBS during and after treatment with ≥37.5 mg daily prednisolone (patients from group 5)

Timeframe: From enrollment to approximately 10-35 days after prednisolone treatment

Trial details

NCT IDNCT07501195

SponsorOve Andersen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-03

Contact for this trial

Ove OA Andersen, Professor

004538626719 ove.andersen@regionh.dk

View on ClinicalTrials.gov More Malnutrition Elderly trials