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

Aging Clinical Trial

— FAM-CPH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03052192
• Other study ID #: FAM-CPH-cohort
• Secondary ID: H-16038786AHH-20
• Status: Active, not recruiting
• Start date: November 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2019
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Denmark	Amager & Hvidovre Hospital	Hvidovre	Region Hovedstaden

Sponsors (4)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Clinical Research Centre, Lundbeck Foundation, Region Hovedstaden

Country where clinical trial is conducted

Denmark, 

Outcome

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