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

NCT07501195 | Recruiting

• 1 other identifier: 89194
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malnutrition Elderly; Kidney Diseases; Dehydration

Outcome Measures

Primary Outcomes (6)

• 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 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)

  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)

  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)

  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)

  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)

Other Outcomes (3)

• Routine biochemistry

  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

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

• Patient demographics

  Conducted at enrollment

Study Arms (6)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• years or older (group 1, 4 and 5)
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ove Andersen: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

Hvidovre Hospital

Copenhagen, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, plasma, serum, buffy coat.

MeSH Terms

Conditions

Kidney Diseases; Dehydration

Condition Hierarchy (Ancestors)

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

Study Officials

• Ove Andersen, Professor

  Department of clinical research, Copenhagen University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ove OA Andersen, Professor

CONTACT

004538626719; ove.andersen@regionh.dk

Rikke Lundsgaard Nielsen, Phd

CONTACT

ove.andersen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, PhD, DMSci in internal medicine, infectious diseases and Clinical Professer at Copenhagen University. Head of the Department of Clinical Research at Amager and Hvidovre Hospital, Research Director at the Hospital.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 30, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2035
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

DK (1)