{"type":"trials","record":{"id":21846,"source_id":"clinicaltrials-gov","external_id":"NCT01765946","title":"Metformin and Longevity Genes in Prediabetes","brief_summary":"Pre-diabetes, a condition characterized by hyperglycaemia, is associated with increased cardiovascular risk and reduced life expectancy, as compared to the general population. AMP-activated protein kinase (AMPK) is an enzyme that plays a key role in cellular energy homeostasis and metabolism, and recently it has been demonstrated that AMPK regulates aging pathways, as well. AMPK is susceptible to modulation through pharmacologic (e.g. metformin) and non-pharmacologic (e.g. physical exercise) interventions. This clinical trial aims to describe the effects of the AMPK pathway on longevity genes and inflammation in the setting of pre-diabetes in vivo and in vitro. To this end, the investigators will compare treatment with metformin (500 mg t.i.d) for 2 months, versus placebo in pre-diabetic subjects. The investigators will assess expression of longevity genes SIRT1, p66Shc, p53 and mTOR in peripheral blood mononuclear cells (PBMCs) ex vivo. The investigators will evaluate monocyte polarization by flow cytometry, according to the expression of surface antigens (CD68, CCR2, CD163, CD206, CX3CR1) to determine the prevalence of pro- or anti-inflammatory cells. Inflammatory cytokines (TNF-alpha, MCP-1, IL-1, IL-6, IL-10, CCL12) will also be determined. In the in vitro study the investigators will evaluate the effects of AMPK activation or inhibition on longevity gene and protein expression.","overall_status":"Completed","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"University of Padova","enrollment":38,"countries":["Italy"],"start_date":"2010-06-01","completion_date":"2013-03-01","last_update_date":"2013-03-13","source_url":"https://clinicaltrials.gov/study/NCT01765946","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:10.897288+00:00","last_seen_at":"2026-09-25T06:15:12.462+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"40 Years to 75 Years","comparator":"Placebo","organization":"University of Padova","interventions":["Metformin","placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Longevity gene expression — 2 month after treatment","Insulin sensitivity — 2 months after treatment","Monocyte polarization status — 2 months after treatment"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Insulin Resistance","Prediabetes","Aging","Inflammation","Metformin","placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":35,"publication_state":"published","match_explanation":"Title contains controlled term: longevity gene.","quality_checked_at":"2026-09-25T06:15:12.620683+00:00","duplicate_cluster_key":"id:nct01765946","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2010-06-01 to 2013-03-01","comparator":"Placebo","confidence":"structured-source","population":"ALL · 40 Years to 75 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":"2026-09-25T06:15:12.463Z","intervention":["Metformin","placebo"],"participants":38,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","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":["Longevity gene expression — 2 month after treatment","Insulin sensitivity — 2 months after treatment","Monocyte polarization status — 2 months after treatment"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"longevity-genetics","is_published":true,"match_reasons":["Title contains controlled term: longevity gene.","Abstract contains controlled term: longevity gene.","Title supplies longevity context: longevity.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Longevity genetics","slug":"longevity-genetics"}},{"topic_slug":"metformin","is_published":true,"match_reasons":["Title contains controlled term: metformin.","Abstract contains controlled term: metformin.","Source terminology contains: metformin.","Title supplies longevity context: longevity.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Metformin","slug":"metformin"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/21846","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}