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NCT Number: NCT07501195

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

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.

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Key information

Conditions

Malnutrition Elderly Dehydration Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital

Copenhagen, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

    mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis

  2. 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)

    mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis

  3. 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)

    BIA/DEXA

  4. 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)

    mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis. Plasma osmolality is used as estimate of hydration status.

  5. 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)

  6. 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)

    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

  7. 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)

    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

  8. To investigate the prevalence of sarcopenia and sarcopenic obesity, and to characterize these groups.

    Time frame: At inclusion and after 2 weeks

    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)

  9. To investigate whether the estimation of body composition is affected by patient dehydration

    Time frame: 2 weeks after inclusion

    DXA/BIA scans, osmolarity estimations (Plasma Natrium, potassium, glucose, urea),

  10. To investigate how differences between GFR estimates are affected by hydration

    Time frame: At Inclusion and two weeks after

    Estimated osmolarity (Plasma Natrium, potassium, glucose, urea), estimated GFR

  11. To determine whether the use of medications with potential dehydrating effects can predict dehydration."

    Time frame: Atr inclusion and two weeks after

    Medication use, osmolarity estimation

  12. To investigate the prevalence of dehydration

    Time frame: At inclusion and two weeks after

    Estimated osmolarity

  13. 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

    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."

  14. To identify potential biomarkers (including inflammatory and aging biomarkers) that may be associated with dehydration

    Time frame: At inclusion and two weeks after

    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.

  15. 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

    BIA/DXA

  16. 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

    Biomarkers will be analyzed afterwards from the blood biobank

  17. To investigate whether the estimation of body composition is affected by physical activity/rest."

    Time frame: 2 weeks after inclusion

    DXA/BIA scans, 400 m walking distance and 15 mins rest

  18. 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

    Biomarkers will be analyzed afterwards from the blood biobank

  19. To investigate whether the estimation of body composition is affected by fasting

    Time frame: 2 weeks after inclusion

    DXA/BIA scans, 24 hours fasting and a light testmeal

Other outcomes

  1. Routine biochemistry

    Time frame: Time of inclusion, time of the mGFRDBS procedure, time of the BIA/DXA-scans or two weeks after the patient has been released from the hospital.

    Standard bloodwork carried out by hospital staff during the patient's hospitalization.: ALAT, albumin, alkaline phosphatase, bilirubin, CO2, CRP, haemoglobin, INR, K+, blood urea nitrogen, coagulation factors, leucocytes, neutrophils, MCH, MCV, Na+, thrombocytes, lactate-dehydrogenases, NGAL, β-trace protein and β-trace microglobulins.

  2. Urine sample

    Time frame: To be carried out just before the commencement of the mGFRDBS procedure.

    Will be conducted in parallel with the mGFRDBS procedure, to measure the albumine kreatinine ratio.

  3. Patient demographics

    Time frame: Conducted at enrollment

    Marital status (single/cohabiting), education level (highest completed education/schooling), lifestyle (PAL or EQ-5D-5L), functional status (CAS), smoking, alcohol consumption, residential status, municipal assistance/care."

Study contacts

Contact information is provided by the study sponsor or research team.

Ove OA Andersen, Professor

CONTACT

[email protected]

004538626719

Rikke Lundsgaard Nielsen, Phd

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Ove Andersen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

Methods for Assessing Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients - An Observational Study (MIKADO)

Acronym: MIKADO

Important dates

Study start
2026
Primary completion
2028
Study completion
2035
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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