{"type":"trials","record":{"id":29561,"source_id":"clinicaltrials-gov","external_id":"NCT02167620","title":"Metformin in Co-morbid Diabetes or Prediabetes and Serious Mental Illness","brief_summary":"Schizophrenia is associated with a lifespan shortened by 20 years, due to cardiovascular disease (CVD), with antipsychotic (AP) medications understood to contribute to this risk through associated metabolic side-effects. Metformin, a medication used to treat prediabetes, and diabetes in the general population, holds promise with regard to reduction of AP-related metabolic problems, but has not been directly tested in early episode patients beyond weight loss, nor specifically in patients with diabetes or prediabetes and psychosis. We propose to replicate findings that metformin can reduce weight gain, and dysglycemia uniquely focusing on an early episode population diagnosed with prediabetes or diabetes. To help determine long-term risk/benefit of adjunctive metformin, we propose to look at changes in abdominal and liver fat, two well-established risk factors for CVD. Given links between dysglycemia, obesity with hippocampal volume loss and cognitive dysfunction, we will explore if improvements in metabolic indices are associated in changes in cognition and brain structure.","overall_status":"Completed","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Centre for Addiction and Mental Health","enrollment":35,"countries":["Canada"],"start_date":"2014-06-01","completion_date":"2018-03-01","last_update_date":"2018-07-30","source_url":"https://clinicaltrials.gov/study/NCT02167620","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":"2026-09-25T01:16:13.338836+00:00","last_seen_at":"2026-09-25T06:00:18.815+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"17 Years to 45 Years","comparator":"Metformin; Placebo","organization":"Centre for Addiction and Mental Health","interventions":["Metformin","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Improvement in HbA1C derived from Oral glucose tolerance test (Matsuda, index of insulin sensitivity; area under glucos…","Decreases in visceral adiposity — 3 years","Decreases in hepatic adiposity — 3 years","Greater than 5% decrease in body weight — 3 years","Improvements in cognition — 3 years","Improvements in hippocampal volume — 3 years"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Diabetes Mellitus, Type 2","Schizophrenia","Metformin","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: metformin.","quality_checked_at":"2026-09-25T06:00:19.43954+00:00","duplicate_cluster_key":"id:nct02167620","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2014-06-01 to 2018-03-01","comparator":"Metformin; Placebo","confidence":"structured-source","population":"ALL · 17 Years to 45 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":"2026-09-25T06:00:18.824Z","intervention":["Metformin","Placebo"],"participants":35,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","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":["Improvement in HbA1C derived from Oral glucose tolerance test (Matsuda, index of insulin sensitivity; area under glucos…","Decreases in visceral adiposity — 3 years","Decreases in hepatic adiposity — 3 years","Greater than 5% decrease in body weight — 3 years","Improvements in cognition — 3 years","Improvements in hippocampal volume — 3 years"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"metformin","is_published":true,"match_reasons":["Title contains controlled term: metformin.","Abstract contains controlled term: metformin.","Source terminology contains: metformin.","Abstract supplies longevity context: lifespan.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","abstract 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/29561","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}