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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Diseases; Dehydration; Malnutrition Elderly

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Ove OA Andersen, Professor; Phone Number: 004538626719; Email: ove.andersen@regionh.dk
• Study Contact Backup: Name: Rikke Lundsgaard Nielsen, Phd; Email: ove.andersen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	From enrollment to follow-up after amputation (approximately 3 weeks after operation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	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)		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	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	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)	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),	2 weeks after inclusion
To investigate how differences between GFR estimates are affected by hydration	Estimated osmolarity (Plasma Natrium, potassium, glucose, urea), estimated GFR	At Inclusion and two weeks after
To determine whether the use of medications with potential dehydrating effects can predict dehydration."	Medication use, osmolarity estimation	Atr inclusion and two weeks after
To investigate the prevalence of dehydration	Estimated osmolarity	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."	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.	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	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	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	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	Enrollment
To investigate whether the estimation of body composition is affected by fasting	DXA/BIA scans, 24 hours fasting and a light testmeal	2 weeks after inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Routine biochemistry	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.	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.
Urine sample	Will be conducted in parallel with the mGFRDBS procedure, to measure the albumine kreatinine ratio.	To be carried out just before the commencement of the mGFRDBS procedure.
Patient demographics	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."	Conducted at enrollment

Collaborators and Investigators

• Sponsor: Ove Andersen
• Collaborators: Hvidovre University Hospital
• Investigators: Principal Investigator: Ove Andersen, Professor, Department of clinical research, Copenhagen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2035

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Water-Electrolyte Imbalance; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Dehydration; Kidney Diseases
• Other Study ID Numbers: 89194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No