An observational study in Malnutrition Elderly, Kidney Diseases and Dehydration, sponsored by Ove Andersen. Recruiting at 1 site in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Ove Andersen · Observational
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.
969 studies on the registry are indexed under Kidney Diseases; 183 are open to participants now.
This study's planned enrollment of 500 is above the median of 245 across 277 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Ove Andersen is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Acutely admitted older medical patients (65 years old or above)
Acutely admitted medical patients, with a difference in eGFR, based on cystatin C and kreatinine of ≥ 30 %.
Hospitalized patients of 90 years or above.
Older hospitalized patients (65 years old or above), with a BMI ≥35 mg/m2.
Patients in active treatment with Prednisolon for COPD exacerbations.
Patiens who are undergoing a lower leg amputation.
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 frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to follow-up after amputation (approximately 3 weeks after operation)
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
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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
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)
BIA/DEXA
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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis. Plasma osmolality is used as estimate of hydration status.
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)
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
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)
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
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.
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)
Time frame: 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),
Time frame: 2 weeks after inclusion
To investigate how differences between GFR estimates are affected by hydration
Estimated osmolarity (Plasma Natrium, potassium, glucose, urea), estimated GFR
Time frame: At Inclusion and two weeks after
To determine whether the use of medications with potential dehydrating effects can predict dehydration."
Medication use, osmolarity estimation
Time frame: Atr inclusion and two weeks after
To investigate the prevalence of dehydration
Estimated osmolarity
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.
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."
Time frame: 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.
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.
BIA/DXA
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)
Biomarkers will be analyzed afterwards from the blood biobank
Time frame: 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
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)
Biomarkers will be analyzed afterwards from the blood biobank
Time frame: Enrollment
To investigate whether the estimation of body composition is affected by fasting
DXA/BIA scans, 24 hours fasting and a light testmeal
Time frame: 2 weeks after inclusion
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 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.
Urine sample
Will be conducted in parallel with the mGFRDBS procedure, to measure the albumine kreatinine ratio.
Time frame: 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."
Time frame: Conducted at enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2028, 24 months after the start.
Of 99 non-industry observational studies under Kidney Diseases, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 33. This study's planned 24 months is below that.
Counting every sponsor, half of 116 studies reached it within 59 months; a quarter within 28 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
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Ove Andersen