{"type":"trials","record":{"id":21939,"source_id":"clinicaltrials-gov","external_id":"NCT07109596","title":"Integration of Clinical, Biological and Psycho-social Variables for a Gender-sensitive Frailty Prediction","brief_summary":"The progressive aging of the population worldwide yields profound health and social implications. Aging entails a progressive impairment of functions and, ultimately, leads to increased susceptibility to morbidity and mortality. Unsurprisingly, over 85% of people over 75 years of age suffer from chronic diseases. Notwithstanding, healthcare systems, usually organized for acute conditions, are not structured to provide effective and efficient care for chronic conditions. Patients with chronic conditions often present a complex interplay of multimorbidity, polypharmacy and frailty. These determinants of health, which are tightly intertwined, are further modulated and influenced by several characteristics of patients, including sex, socio-economic factors and the broad spectrum of the so - called gender-related characteristics of the individuals. The combination of these determinants - whose interaction is often unpredictable - contribute to defining the prognosis of these patients. Frailty is proposed as a state of increased vulnerability and strongly characterizes the older population (Clegg A, Lancet 2013; 381: 752-62). Nonetheless, older age does not always imply a condition of frailty. The development of a simple frailty index can be useful in clinical practice to stratify patients according to their level of frailty, taking into account the specific gender peculiarities, and may facilitate the appropriate tailoring of social- and health-related interventions. One of the factors that accelerates biological aging and increases susceptibility to frailty is a chronic, low-grade and systemic inflammation known as inflammaging. (Ferrucci L, et al. Nat Rev Cardiol 2018). Aging-associated platelet hyperreactivity is driven by chronic inflammation (Pavel Davizon-Castillo et al. Blood 2019) and is associated with chronic age-related cardiovascular disease and mortality. In turn activated platelets fuel inflammation creating a vicious cycle known as thromboinflammation. Both the hemostatic and the immune system display sexual dimorphism and are susceptible to gender-related factors, such as diet, stress, workload, etc. Identification of thromboinflammatory biomarkers could be a novel valuable asset to understand and predict frailty in a more sex and gender sensitive manner in the aging population. Another aging feature is malnutrition, which can significantly contribute to quality of life and clinical outcomes. In particular, the age-related progressive loss of muscle mass and function (i.e.,sarcopenia) reduces the autonomy of older adults, impinges on their quality of life and reduces the tolerance to chronic as well acute therapeutic interventions. Recent evidence suggests that sarcopenia could be considered as a proxy for biological age (Mandelblatt et al. JAMA Oncol 2021). Therefore, timely diagnosis and treatment of impending malnutrition and sarcopenia could ameliorate not only patients' quality of life but survival as well (Bargetzi L et al. Ann…","overall_status":"Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"University of Roma La Sapienza","enrollment":1000,"countries":["Italy"],"start_date":"2025-06-01","completion_date":"2028-12-31","last_update_date":"2025-08-07","source_url":"https://clinicaltrials.gov/study/NCT07109596","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:12.439005+00:00","last_seen_at":"2026-09-25T06:25:30.723+00:00","metadata":{"sex":"ALL","acronym":"AGE-IT","age_range":"56 Years","comparator":null,"organization":"University of Roma La Sapienza","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Sex and gender specific frailty index — 1 year"],"design_description":null,"source_has_results":false},"controlled_terms":["Aging Frailty"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:25:35.871646+00:00","duplicate_cluster_key":"id:nct07109596","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-06-01 to 2028-12-31","comparator":null,"confidence":"structured-source","population":"ALL · 56 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:30.740Z","intervention":[],"participants":1000,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Sex and gender specific frailty index — 1 year"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty, frailty index.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/21939","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}