{"type":"trials","record":{"id":29250,"source_id":"clinicaltrials-gov","external_id":"NCT06433427","title":"Metabolic Dysregulation as Biomarker of Frailty: Role of the Mitochondrial Dysfunction","brief_summary":"The goal of this observational study is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity, and to identify possible frailty biomarkers correlated with mitochondrial dysfunction. The main questions it aims to answer are: * What is the role of oxidative stress-related mitochondrial dysfunction in frailty, taking into account the interaction with multimorbidity. * What could be the specific biomarkers associated with mitochondrial dysfunction in the assessment of frailty. In order to reach the study goals, we will enroll three categories of older adults: * Non-Frail without Multimorbidity (NFWoM); * Frail with Multimorbidity (FWM); * Frail without Multimorbidity (FWoM). Each individual will undergo an assessment of frailty phenotype and multimorbidity, and the collection of blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). The identification of frailty biomarkers in each group of participants will be performed by combining untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and their subpopulations. Multivariate statistical and machine learning techniques will characterize the three clinical phenotype groups based on molecular data.","overall_status":"Unknown","phases":[],"study_type":"OBSERVATIONAL","sponsor":"University Hospital of Ferrara","enrollment":75,"countries":[],"start_date":"2024-05-29","completion_date":"2026-02-22","last_update_date":"2024-05-29","source_url":"https://clinicaltrials.gov/study/NCT06433427","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Unknown. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:08.862442+00:00","last_seen_at":"2026-09-25T06:25:30.723+00:00","metadata":{"sex":"ALL","acronym":"FRAMITO","age_range":"65 Years","comparator":null,"organization":"University Hospital of Ferrara","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Difference in the mtDNA copy number between frail individuals with vs without multimorbidity — Baseline","Difference in the mtDNA copy number between non-frail vs frail individuals without multimorbidity — Baseline","Variation in the mean intensity of mitochondrial fluorescence between non-frail vs frail individuals without multimorbi…","Variation in the mean intensity of mitochondrial fluorescence between frail individuals with vs without multimorbidity…","Difference of intracellular Reactive Oxygen Species (ROS) between non-frail vs frail individuals without multimorbidity…","Difference of intracellular Reactive Oxygen Species (ROS) between frail individuals with vs without multimorbidity — Ba…","Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between non-frail vs frail individuals…","Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between frail individuals with vs with…"],"design_description":null,"source_has_results":false},"controlled_terms":["Aging","Frailty","Mitochondrial Dysfunction","Chronic Disease"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: mitochondrial dysfunction.","quality_checked_at":"2026-09-25T06:25:35.871646+00:00","duplicate_cluster_key":"id:nct06433427","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-05-29 to 2026-02-22","comparator":null,"confidence":"structured-source","population":"ALL · 65 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":"2026-09-25T06:25:30.748Z","intervention":[],"participants":75,"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":["Difference in the mtDNA copy number between frail individuals with vs without multimorbidity — Baseline","Difference in the mtDNA copy number between non-frail vs frail individuals without multimorbidity — Baseline","Variation in the mean intensity of mitochondrial fluorescence between non-frail vs frail individuals without multimorbi…","Variation in the mean intensity of mitochondrial fluorescence between frail individuals with vs without multimorbidity…","Difference of intracellular Reactive Oxygen Species (ROS) between non-frail vs frail individuals without multimorbidity…","Difference of intracellular Reactive Oxygen Species (ROS) between frail individuals with vs without multimorbidity — Ba…","Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between non-frail vs frail individuals…","Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between frail individuals with vs with…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"mitochondrial-function","is_published":true,"match_reasons":["Title contains controlled term: mitochondrial dysfunction.","Abstract contains controlled term: mitochondrial dysfunction.","Source terminology contains: mitochondrial dysfunction.","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":"Mitochondrial function","slug":"mitochondrial-function"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/29250","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}