Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-27 @ 5:28 AM
Study NCT ID:
NCT03052192
Status:
UNKNOWN
Last Update Posted:
2019-10-15
First Post:
2017-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, plasma, serum, buffy coat.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2017-01-05', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sit-to-stand test', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Development in physical performance'}, {'measure': 'Cognitive functional ability', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Orientation memory concentration, mini mental state examination, Hopkins verbal learning test, trail making test, digit symbol substitution test'}, {'measure': 'Waist circumference (cm)', 'timeFrame': 'From inclusion to 56 weeks after discharge'}, {'measure': 'Handgrip strength (kg) of dominant hand', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Development in physical performance'}, {'measure': 'Habitual 4 m gait speed (m/s)', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Development in physical performance'}, {'measure': 'Plasma and serum concentrations of admission blood samples', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Routinely analyzed physiological biomarkers measured in plasma and serum'}, {'measure': 'Blood concentration of cholesterol and triglycerides', 'timeFrame': 'From inclusion to 56 weeks after discharge'}, {'measure': 'Blood concentration of metabolic markers', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Measurement of insulin, blood glucose, and HbA1c'}, {'measure': 'Plasma concentration of active drug substances', 'timeFrame': 'From inclusion to 56 weeks after discharge'}, {'measure': 'CMV-IgG (Cytomegalovirus-immunoglobulin G)', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Cytomegalovirus IgG titer'}], 'primaryOutcomes': [{'measure': 'Eating validation scheme score', 'timeFrame': 'From inclusion to 4 weeks after discharge', 'description': 'Development in nutritional status and risk factors of malnutrition within the FAM group.'}, {'measure': 'MAI score (Medication Appropriateness Index)', 'timeFrame': 'From inclusion to 4 weeks after discharge', 'description': 'Difference in summed MAI-score per patient. MAI score between inclusion and first follow-up visit (FAM group)'}, {'measure': 'NF-kB (Nuclear Factor Kappa light chain enhancer og activated B cells) activity', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': '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.'}, {'measure': 'Chronic inflammation', 'timeFrame': 'From inclusion to 4 weeks after inclusion', 'description': 'Stability and discriminative ability of new model for chronic inflammation (Control group 2)'}, {'measure': 'NLRP3 activity', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Difference in NLRP3 inflammasome activity between groups.'}], 'secondaryOutcomes': [{'measure': 'Bodyweight (kg)', 'timeFrame': 'From inclusion to 4 and 56 weeks after discharge', 'description': 'Development in bodyweight'}, {'measure': 'Quality of life', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'EQ-5D-5L(EuroQol-5Dimentions-5Llevels), mini geriatric depression score'}, {'measure': 'Medication under-prescribing', 'timeFrame': 'From inclusion to 4 weeks after discharge', 'description': 'Assessment of underutilization Index (AOU)'}, {'measure': 'Inflammation in malnourished patients', 'timeFrame': '4 weeks after discharge', 'description': 'Characterize the level of inflammation in malnourished patients'}, {'measure': 'Functional recovery score', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Assessing activities of daily living to characterize development in physical performance'}, {'measure': 'Cystatin C', 'timeFrame': 'From inclusion to 56 weeks after discharge'}, {'measure': 'Cytokine concentrations', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'The concentration of cytokines at baseline and in response to stimulation will be measured'}, {'measure': 'Cytometry', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Characterization of immune cell subsets'}, {'measure': 'miRNA', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Levels of miRNA will be measured, and their association with NF-kB activity and biological ageing will be investigated.'}, {'measure': 'NF-kB activation', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'The activation of NF-kB in response to stimulation.'}, {'measure': 'C-reactive protein (inflammation)', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'Difference in inflammation between groups'}, {'measure': 'Soluble urokinase plasminogen activator receptor (suPAR) (ng/ml)', 'timeFrame': 'From inclusion to 56 weeks after discharge', 'description': 'The plasma level of suPAR is a measure of inflammation and can be used to assess the difference in inflammation between groups'}, {'measure': "Frequency of physicians' acceptance of suggested changes in medications", 'timeFrame': 'At inclusion and at 4 weeks after discharge in the FAM group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Aging', 'Polypharmacy', 'Malnutrition', 'Inflammation', 'Emergency Service, Hospital']}, 'referencesModule': {'references': [{'pmid': '36136804', 'type': 'DERIVED', 'citation': 'Bornaes O, Andersen AL, Houlind MB, Kallemose T, Tavenier J, Aharaz A, Nielsen RL, Jorgensen LM, Beck AM, Andersen O, Petersen J, Pedersen MM. Mild Cognitive Impairment Is Associated with Poorer Nutritional Status on Hospital Admission and after Discharge in Acutely Hospitalized Older Patients. Geriatrics (Basel). 2022 Sep 10;7(5):95. doi: 10.3390/geriatrics7050095.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Malnutrition:\n\nMalnutrition 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.\n\nInappropriate polypharmacy:\n\nThe 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) .\n\nChronic inflammation and biological aging:\n\nChronic 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Three study groups; the FAM group, control group 1 and control group 2', 'healthyVolunteers': True, 'eligibilityCriteria': 'FAM group:\n\nInclusion Criteria:\n\n* ≥65 years\n* Acute medical patient\n* Understands and speaks Danish\n\nExclusion Criteria:\n\n* Unable to cooperate cognitively\n* Terminal patients\n* Patients in isolation\n\nControl group 1:\n\nInclusion Criteria:\n\n* ≥65 years\n* No hospital admissions within the past 2 years\n\nExclusion Criteria:\n\n* Acute admissions within the past 2 years\n* Auto-immune diseases\n* Treatment with immunosuppressive or biological therapies\n\nControl group 2:\n\nInclusion Criteria:\n\n* 20-35 years\n* Caucasian\n* 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.)\n\nExclusion Criteria:\n\n* Auto-immune or chronic diseases'}, 'identificationModule': {'nctId': 'NCT03052192', 'acronym': 'FAM-CPH', 'briefTitle': 'Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.', 'orgStudyIdInfo': {'id': 'FAM-CPH-cohort'}, 'secondaryIdInfos': [{'id': 'H-16038786', 'type': 'OTHER', 'domain': 'Committees on Health Research Ethics'}, {'id': 'AHH-2016-067 (I-suite 04931)', 'type': 'OTHER', 'domain': 'Danish Data Protection Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'FAM group (n=98)', 'description': '≥65 years. Acutely admitted medical patients.\n\nIncluded consecutively at admission to the Acute Medical Department at Amager and Hvidovre Hospital and Rigshospitalet - Glostrup.\n\nFollow-up at 4 weeks and 56 weeks after discharge and at any readmissions in the study period.\n\nParticipants are interviewed on physical, mental and nutritional status, tested for functional and cognitive status, and have anthropometry, biochemistry, blood pressure, and immune activity measured. Participants are followed in national registries for information on diagnoses, hospital admissions, health care services used, and mortality.\n\nIf a patient uses ≥5 prescribed drugs before hospitalization, a medication review will be performed by a clinical pharmacist and a geriatrician.\n\nSample size calculations were performed for each primary outcome, and the final sample size was based on the calculation for the eating validation scheme which resulted in the largest sample size.'}, {'label': 'Control group 1 (n=54)', 'description': '≥65 years. No hospital admissions within the past two years.\n\nMatched individually with patients in the FAM group by age, sex, and municipality.\n\nExamined at inclusion and 52 weeks after inclusion.\n\nParticipants are interviewed on physical, mental and nutritional status, tested for functional and cognitive status, and have anthropometry, biochemistry, blood pressure, and immune activity measured. Participants are followed in national registries for information on diagnoses, hospital admissions, health care services used, and mortality.'}, {'label': 'Control group 2 (n=60)', 'description': '20-35 years 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.)\n\nExamined at inclusion and 4 weeks after inclusion. The examination includes a questionnaire about life style, a physical examination, and blood samples.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Amager & Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Ove Andersen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hvidovre University Hospital'}, {'name': 'Morten B. Houlind, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}, {'name': 'Juliette Tavenier, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}, {'name': 'Line JH Rasmussen, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}, {'name': 'Aino L Andersen, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Research Centre', 'class': 'UNKNOWN'}, {'name': 'Lundbeck Foundation', 'class': 'OTHER'}, {'name': 'Region Hovedstadens Apotek', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinical Research Centre', 'investigatorFullName': 'Ove Andersen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}