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Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.

Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03052192
Acronym
FAM-CPH
Enrollment
212
Registered
2017-02-14
Start date
2016-11-30
Completion date
2019-12-31
Last updated
2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Emergency Service, Hospital, Inflammation, Malnutrition, Polypharmacy

Brief summary

In this study, the investigators will investigate and characterize acute medical patients in order to optimize patient courses in the acute care departments, especially with regard to polypharmacy and undernourishment. In addition, the investigators will investigate underlying immunological mechanisms of chronic inflammation and biological aging in this population to improve the current knowledge and possibilities for preventing chronic diseases and acute hospitalization.

Detailed description

Malnutrition: Malnutrition among elderly is associated with frailty, including loss of weight, muscle mass, function and quality of life and also with an increased number of hospital admissions. In this study, the investigators aim to describe the development of and the risk factors for malnutrition from admission to 4 weeks after discharge, in addition the investigators wish to characterize the inflammatory state of the malnourished patients. Inappropriate polypharmacy: The broad variation among elderly in health, number of chronic diseases, organ function, biological age and function makes the prescription of drugs to this population a very complex task with a high risk of inappropriate medication. 5-30% of all non-elective admissions are caused by inappropriate medications, and many of these are preventable. Therefore, the investigators aim to investigate the feasibility of a pharmacist-geriatrician medication review in the acute care department and the effect on the Medication Appropriateness Index score (MAI-score) . Chronic inflammation and biological aging: Chronic inflammation and biological aging promote the development of age-related chronic diseases. There is a large variation in the rate of aging between individuals, in particular among the elderly. This means that the chronological age of a person often does not reflect its true state of aging, the biological age. This challenges the ability to provide appropriate care and to predict responses to treatment and interventions in elderly patients. The underlying causes and mechanisms of biological aging and chronic inflammation are not well understood. There are currently no validated methods for measuring biological age and no measures of chronic inflammation which can be used in an acute setting. Here, the investigators aim to test a novel model for chronic inflammation and investigate the role of the NLRP3 inflammasome, NFkB (nuclear factor kappa light chain enhancer of activated B cells) and miRNAs in biological aging and chronic inflammation. The study is prospective with 3 groups of study participants: one group is included in the Acute Medical Department and two healthy control groups (one young and one older). The follow-up comprises two predefined examinations and any readmissions at our hospital. Furthermore, participants are followed in the national registries.

Interventions

None listed

Sponsors

Clinical Research Centre
CollaboratorUNKNOWN
Lundbeck Foundation
CollaboratorOTHER
Region Hovedstadens Apotek
CollaboratorOTHER_GOV
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 110 Years
Healthy volunteers
Yes

Inclusion criteria

FAM group: Inclusion Criteria: * ≥65 years * Acute medical patient * Understands and speaks Danish

Exclusion criteria

* Unable to cooperate cognitively * Terminal patients * Patients in isolation Control group 1: Inclusion Criteria: * ≥65 years * No hospital admissions within the past 2 years

Design outcomes

Primary

MeasureTime frameDescription
Eating validation scheme scoreFrom inclusion to 4 weeks after dischargeDevelopment in nutritional status and risk factors of malnutrition within the FAM group.
NLRP3 activityFrom inclusion to 56 weeks after dischargeDifference in NLRP3 inflammasome activity between groups.
Chronic inflammationFrom inclusion to 4 weeks after inclusionStability and discriminative ability of new model for chronic inflammation (Control group 2)
NF-kB (Nuclear Factor Kappa light chain enhancer og activated B cells) activityFrom inclusion to 56 weeks after dischargeThe development in NF-kB activity between the groups will be investigated. The association of NF-kB activity with biological ageing-measured by chronic inflammation, and loss of function and cognition-will also be investigated.
MAI score (Medication Appropriateness Index)From inclusion to 4 weeks after dischargeDifference in summed MAI-score per patient. MAI score between inclusion and first follow-up visit (FAM group)

Secondary

MeasureTime frameDescription
Functional recovery scoreFrom inclusion to 56 weeks after dischargeAssessing activities of daily living to characterize development in physical performance
Medication under-prescribingFrom inclusion to 4 weeks after dischargeAssessment of underutilization Index (AOU)
Inflammation in malnourished patients4 weeks after dischargeCharacterize the level of inflammation in malnourished patients
Cystatin CFrom inclusion to 56 weeks after discharge
Cytokine concentrationsFrom inclusion to 56 weeks after dischargeThe concentration of cytokines at baseline and in response to stimulation will be measured
CytometryFrom inclusion to 56 weeks after dischargeCharacterization of immune cell subsets
miRNAFrom inclusion to 56 weeks after dischargeLevels of miRNA will be measured, and their association with NF-kB activity and biological ageing will be investigated.
NF-kB activationFrom inclusion to 56 weeks after dischargeThe activation of NF-kB in response to stimulation.
C-reactive protein (inflammation)From inclusion to 56 weeks after dischargeDifference in inflammation between groups
Soluble urokinase plasminogen activator receptor (suPAR) (ng/ml)From inclusion to 56 weeks after dischargeThe plasma level of suPAR is a measure of inflammation and can be used to assess the difference in inflammation between groups
Frequency of physicians' acceptance of suggested changes in medicationsAt inclusion and at 4 weeks after discharge in the FAM group
Bodyweight (kg)From inclusion to 4 and 56 weeks after dischargeDevelopment in bodyweight
Quality of lifeFrom inclusion to 56 weeks after dischargeEQ-5D-5L(EuroQol-5Dimentions-5Llevels), mini geriatric depression score

Other

MeasureTime frameDescription
Blood concentration of cholesterol and triglyceridesFrom inclusion to 56 weeks after discharge
Blood concentration of metabolic markersFrom inclusion to 56 weeks after dischargeMeasurement of insulin, blood glucose, and HbA1c
Plasma concentration of active drug substancesFrom inclusion to 56 weeks after discharge
CMV-IgG (Cytomegalovirus-immunoglobulin G)From inclusion to 56 weeks after dischargeCytomegalovirus IgG titer
Waist circumference (cm)From inclusion to 56 weeks after discharge
Cognitive functional abilityFrom inclusion to 56 weeks after dischargeOrientation memory concentration, mini mental state examination, Hopkins verbal learning test, trail making test, digit symbol substitution test
Plasma and serum concentrations of admission blood samplesFrom inclusion to 56 weeks after dischargeRoutinely analyzed physiological biomarkers measured in plasma and serum
Habitual 4 m gait speed (m/s)From inclusion to 56 weeks after dischargeDevelopment in physical performance
Sit-to-stand testFrom inclusion to 56 weeks after dischargeDevelopment in physical performance
Handgrip strength (kg) of dominant handFrom inclusion to 56 weeks after dischargeDevelopment in physical performance

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026