Aging Clinical Trial
— FAM-CPHOfficial title:
Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.
Verified date | October 2019 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 212 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 110 Years |
Eligibility |
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 Exclusion Criteria: - Acute admissions within the past 2 years - Auto-immune diseases - Treatment with immunosuppressive or biological therapies Control group 2: Inclusion Criteria: - 20-35 years - Caucasian - No admissions due to chronic or critical illness within the past 5 years (except admissions related to child birth, abortion, appendicitis, poisoning, traumas, concussion etc.) Exclusion Criteria: - Auto-immune or chronic diseases |
Country | Name | City | State |
---|---|---|---|
Denmark | Amager & Hvidovre Hospital | Hvidovre | Region Hovedstaden |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | Clinical Research Centre, Lundbeck Foundation, Region Hovedstaden |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sit-to-stand test | Development in physical performance | From inclusion to 56 weeks after discharge | |
Other | Cognitive functional ability | Orientation memory concentration, mini mental state examination, Hopkins verbal learning test, trail making test, digit symbol substitution test | From inclusion to 56 weeks after discharge | |
Other | Waist circumference (cm) | From inclusion to 56 weeks after discharge | ||
Other | Handgrip strength (kg) of dominant hand | Development in physical performance | From inclusion to 56 weeks after discharge | |
Other | Habitual 4 m gait speed (m/s) | Development in physical performance | From inclusion to 56 weeks after discharge | |
Other | Plasma and serum concentrations of admission blood samples | Routinely analyzed physiological biomarkers measured in plasma and serum | From inclusion to 56 weeks after discharge | |
Other | Blood concentration of cholesterol and triglycerides | From inclusion to 56 weeks after discharge | ||
Other | Blood concentration of metabolic markers | Measurement of insulin, blood glucose, and HbA1c | From inclusion to 56 weeks after discharge | |
Other | Plasma concentration of active drug substances | From inclusion to 56 weeks after discharge | ||
Other | CMV-IgG (Cytomegalovirus-immunoglobulin G) | Cytomegalovirus IgG titer | From inclusion to 56 weeks after discharge | |
Primary | Eating validation scheme score | Development in nutritional status and risk factors of malnutrition within the FAM group. | From inclusion to 4 weeks after discharge | |
Primary | MAI score (Medication Appropriateness Index) | Difference in summed MAI-score per patient. MAI score between inclusion and first follow-up visit (FAM group) | From inclusion to 4 weeks after discharge | |
Primary | NF-kB (Nuclear Factor Kappa light chain enhancer og activated B cells) activity | The 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. | From inclusion to 56 weeks after discharge | |
Primary | Chronic inflammation | Stability and discriminative ability of new model for chronic inflammation (Control group 2) | From inclusion to 4 weeks after inclusion | |
Primary | NLRP3 activity | Difference in NLRP3 inflammasome activity between groups. | From inclusion to 56 weeks after discharge | |
Secondary | Bodyweight (kg) | Development in bodyweight | From inclusion to 4 and 56 weeks after discharge | |
Secondary | Quality of life | EQ-5D-5L(EuroQol-5Dimentions-5Llevels), mini geriatric depression score | From inclusion to 56 weeks after discharge | |
Secondary | Medication under-prescribing | Assessment of underutilization Index (AOU) | From inclusion to 4 weeks after discharge | |
Secondary | Inflammation in malnourished patients | Characterize the level of inflammation in malnourished patients | 4 weeks after discharge | |
Secondary | Functional recovery score | Assessing activities of daily living to characterize development in physical performance | From inclusion to 56 weeks after discharge | |
Secondary | Cystatin C | From inclusion to 56 weeks after discharge | ||
Secondary | Cytokine concentrations | The concentration of cytokines at baseline and in response to stimulation will be measured | From inclusion to 56 weeks after discharge | |
Secondary | Cytometry | Characterization of immune cell subsets | From inclusion to 56 weeks after discharge | |
Secondary | miRNA | Levels of miRNA will be measured, and their association with NF-kB activity and biological ageing will be investigated. | From inclusion to 56 weeks after discharge | |
Secondary | NF-kB activation | The activation of NF-kB in response to stimulation. | From inclusion to 56 weeks after discharge | |
Secondary | C-reactive protein (inflammation) | Difference in inflammation between groups | From inclusion to 56 weeks after discharge | |
Secondary | Soluble urokinase plasminogen activator receptor (suPAR) (ng/ml) | The plasma level of suPAR is a measure of inflammation and can be used to assess the difference in inflammation between groups | From inclusion to 56 weeks after discharge | |
Secondary | Frequency of physicians' acceptance of suggested changes in medications | At inclusion and at 4 weeks after discharge in the FAM group |
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