Malnutrition ElderlyMIKADONCT07501195
Methods for Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients
An observational study of Malnutrition Elderly and Kidney Diseases, run by Ove Andersen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition Elderly, Kidney Diseases, Dehydration
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2026to Sep 2035
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: There are 6 patient groups in this study: Group 1: Elderly, 65 years old or above, acutely admitted medical patients. Group 2: Acutely admitted medical patients, with a difference in eGFR, based on cystatin C and kreatinine of ≥ 30 %. Group 3: Hospitalized patients of 90 years or above. Group 4: Elderly (≥65 år), hospitalized patients, with a BMI ≥35 mg/m2. Group 5: Patients in active treatment with Prednisolon for COPD exacerbations. Group 6: Patiens who are undergoing a lower leg amputation.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rikke Lundsgaard Nielsen, Phd contact
About this study
Official title: Methods for Assessing Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients - An Observational Study (MIKADO)
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.
- Conditions
- Malnutrition Elderly, Kidney Diseases, Dehydration
- Medical subject headings
- Kidney Diseases, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Acutely admitted older medical patients (65 years old or above) | |
| Group 2: | Acutely admitted medical patients, with a difference in eGFR, based on cystatin C and kreatinine of ≥ 30 %. | |
| Group 3: | Hospitalized patients of 90 years or above. | |
| Group 4: | Older hospitalized patients (65 years old or above), with a BMI ≥35 mg/m2. | |
| Group 5: | Patients in active treatment with Prednisolon for COPD exacerbations. | |
| Group 6: | Patiens who are undergoing a lower leg amputation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate whether the method used to determine body composition affects the diagnosis of malnutrition when applying the GLIM criteria.
This will be conducted via BIA- and DXA-scans and with the use of GLIM criteria
Measured: 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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
Measured: 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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
Measured: 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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
Measured: 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)
mGFRDBS will be performed twice
Measured: From enrollment to approximately 10-35 days after prednisolone treatment
To determine changes in mGFRDBS before and after amputation (patients from group 6)
mGFRDBS will be performed twice
Measured: From enrollment to follow-up after amputation (approximately 3 weeks after operation)
Secondary outcomes (19)
To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS during and after treatment with ≥37.5 mg daily prednisolone (patients from group 5)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
Measured: From enrollment to approximately 10-35 days after prednisolone treatment
To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS before and after amputation (patients from group 6)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
Measured: From enrollment to follow-up after amputation (approximately 3 weeks after operation)
To investigate the impact of body composition on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
BIA/DEXA
Measured: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the impact of hydration status on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis. Plasma osmolality is used as estimate of hydration status.
Measured: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the impact of inflammatory and aging markers on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
Measured: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the impact of nutritional status on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis. For nutritional status, metrics like SNAQ, MNA, GLIM, and NRS-2002
Measured: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the impact of performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to dosing of renal risk medications (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis. Renal risk medications are identified and assessed for dosing agreement across eGFR in relation to mGFRDBS
Measured: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the prevalence of sarcopenia and sarcopenic obesity, and to characterize these groups.
Assessed with Nutritonal status (NRS-2022, GLIM, MNA, SNAQ), bodycomposition with BIA/DXA, inflammatory biomarkers (such as GDF15), muscle function (HGS), physical performance (4 m gaitspeed) hydration (Plasma Natrium, potassium, glucose, urea)
Measured: At inclusion and after 2 weeks
To investigate whether the estimation of body composition is affected by patient dehydration
DXA/BIA scans, osmolarity estimations (Plasma Natrium, potassium, glucose, urea),
Measured: 2 weeks after inclusion
To investigate how differences between GFR estimates are affected by hydration
Estimated osmolarity (Plasma Natrium, potassium, glucose, urea), estimated GFR
Measured: At Inclusion and two weeks after
To determine whether the use of medications with potential dehydrating effects can predict dehydration."
Medication use, osmolarity estimation
Measured: Atr inclusion and two weeks after
To investigate the prevalence of dehydration
Estimated osmolarity
Measured: At inclusion and two weeks after
To test and identify potential biomarkers, both individually and in a panel of multiple biomarkers (including inflammatory and aging biomarkers), that may be associated with or identify undernutrition and the risk of undernutrition.
Cytokines, growth factors, and other proteins measured by immunoassays (e.g., ELISA, PEA technology [Olink, Organ Damage (n=92) and Inflammation (n=92) panels]), including GDF15, FGF21, suPAR, IL-1β, IL-6, IL-10, TNF-α.
Biological aging assessed by DNA methylation."
Measured: At inclusion and two weeks after
To identify potential biomarkers (including inflammatory and aging biomarkers) that may be associated with dehydration
Cytokines, growth factors, and other proteins measured by immunoassays (e.g., ELISA, PEA technology [Olink, organ damage (n=92) and inflammation (n=92) panels]), including GDF15, FGF21, suPAR, IL-1β, IL-6, IL-10, and TNF-α. Biological aging assessed by DNA methylation.
Measured: At inclusion and two weeks after
To investigate differences in body composition during and after hospitalization for the patients included in sub-study 2A.
BIA/DXA
Measured: At inclusion and two weeks after
To characterize biomarker levels for inflammation, metabolism, aging and tissue damage in patients aged ≥90 år (patients from groups 1 and 3)
Biomarkers will be analyzed afterwards from the blood biobank
Measured: Enrollment
To investigate whether the estimation of body composition is affected by physical activity/rest."
DXA/BIA scans, 400 m walking distance and 15 mins rest
Measured: 2 weeks after inclusion
To characterize biomarker levels for inflammation, metabolism, aging and tissue damage in patients with BMI ≥35 kg/m2 (patients from groups 1 and 4)
Biomarkers will be analyzed afterwards from the blood biobank
Measured: Enrollment
To investigate whether the estimation of body composition is affected by fasting
DXA/BIA scans, 24 hours fasting and a light testmeal
Measured: 2 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition ElderlyStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ove Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Sponsor-investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Ove Andersen, Professor, Principal investigator, Department of clinical research, Copenhagen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501195
- Sponsor's protocol ID
- 89194
- Acronym
- MIKADO
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Mar 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods for Assessing Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients - An Observational Study (MIKADO)
- ClinicalTrials.gov ID
- NCT07501195
- Acronym / sponsor ID
- MIKADO / 89194
- Conditions
- Malnutrition Elderly, Kidney Diseases, Dehydration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ove AndersenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 30 Mar 2026 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Acutely admitted older medical patients (65 years old or above) |
| Group 2: | – | –Acutely admitted medical patients, with a difference in eGFR, based on cystatin C and kreatinine of ≥ 30 %. |
| Group 3: | – | –Hospitalized patients of 90 years or above. |
| Group 4: | – | –Older hospitalized patients (65 years old or above), with a BMI ≥35 mg/m2. |
| Group 5: | – | –Patients in active treatment with Prednisolon for COPD exacerbations. |
| Group 6: | – | –Patiens who are undergoing a lower leg amputation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- There are 6 patient groups in this study: Group 1: Elderly, 65 years old or above, acutely admitted medical patients. Group 2: Acutely admitted medical patients, with a difference in eGFR, based on cystatin C and kreatinine of ≥ 30 %. Group 3: Hospitalized patients of 90 years or above. Group 4: Elderly (≥65 år), hospitalized patients, with a BMI ≥35 mg/m2. Group 5: Patients in active treatment with Prednisolon for COPD exacerbations. Group 6: Patiens who are undergoing a lower leg amputation.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
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
To investigate whether the method used to determine body composition affects the diagnosis of malnutrition when applying the GLIM criteria.
Time frame: Time of inclusion and/or 14 days after preliminary inclusion.
This will be conducted via BIA- and DXA-scans and with the use of GLIM criteria
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)
Time frame: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
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)
Time frame: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
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)
Time frame: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
To determine changes in mGFRDBS during and after treatment with ≥37.5 mg daily prednisolone (patients from group 5)
Time frame: From enrollment to approximately 10-35 days after prednisolone treatment
mGFRDBS will be performed twice
To determine changes in mGFRDBS before and after amputation (patients from group 6)
Time frame: From enrollment to follow-up after amputation (approximately 3 weeks after operation)
mGFRDBS will be performed twice
19 secondary outcomes
To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS during and after treatment with ≥37.5 mg daily prednisolone (patients from group 5)
Time frame: From enrollment to approximately 10-35 days after prednisolone treatment
To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS before and after amputation (patients from group 6)
Time frame: From enrollment to follow-up after amputation (approximately 3 weeks after operation)
To investigate the impact of body composition on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the impact of hydration status on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the impact of inflammatory and aging markers on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the impact of nutritional status on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the impact of performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to dosing of renal risk medications (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation)
Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)
To investigate the prevalence of sarcopenia and sarcopenic obesity, and to characterize these groups.
Time frame: At inclusion and after 2 weeks
To investigate whether the estimation of body composition is affected by patient dehydration
Time frame: 2 weeks after inclusion
To investigate how differences between GFR estimates are affected by hydration
Time frame: At Inclusion and two weeks after
To determine whether the use of medications with potential dehydrating effects can predict dehydration."
Time frame: Atr inclusion and two weeks after
To investigate the prevalence of dehydration
Time frame: At inclusion and two weeks after
To test and identify potential biomarkers, both individually and in a panel of multiple biomarkers (including inflammatory and aging biomarkers), that may be associated with or identify undernutrition and the risk of undernutrition.
Time frame: At inclusion and two weeks after
To identify potential biomarkers (including inflammatory and aging biomarkers) that may be associated with dehydration
Time frame: At inclusion and two weeks after
To investigate differences in body composition during and after hospitalization for the patients included in sub-study 2A.
Time frame: At inclusion and two weeks after
To characterize biomarker levels for inflammation, metabolism, aging and tissue damage in patients aged ≥90 år (patients from groups 1 and 3)
Time frame: Enrollment
To investigate whether the estimation of body composition is affected by physical activity/rest."
Time frame: 2 weeks after inclusion
To characterize biomarker levels for inflammation, metabolism, aging and tissue damage in patients with BMI ≥35 kg/m2 (patients from groups 1 and 4)
Time frame: Enrollment
To investigate whether the estimation of body composition is affected by fasting
Time frame: 2 weeks after inclusion
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 30 Mar 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.
Rikke Lundsgaard Nielsen, Phd contact
Ove Andersen, Professor principal investigator
Department of clinical research, Copenhagen 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 Elderly and Kidney Diseases, run by Ove Andersen at 1 site in Denmark.
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 8 inclusion and 6 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 30 Mar 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 Denmark. 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 Ove OA Andersen, Professor (004538626719, ove.andersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate whether the method used to determine body composition affects the diagnosis of malnutrition when applying the GLIM criteria. (time frame: Time of inclusion and/or 14 days after preliminary inclusion.). The study lists 6 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 30 Mar 2026.