{"type":"trials","record":{"id":98,"source_id":"clinicaltrials-gov","external_id":"NCT00038727","title":"Diabetes Prevention Program Outcomes Study","brief_summary":"The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (\\~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","enrollment":2779,"countries":["United States"],"start_date":"1996-07-31","completion_date":"2022-04-30","last_update_date":"2026-07-30","source_url":"https://clinicaltrials.gov/study/NCT00038727","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-14T02:45:00.13201+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"DPPOS","age_range":"25 Years","comparator":"1 Original Lifestyle; 2 Original Metformin; 3 Original Placebo","organization":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","interventions":["DPPOS Group Lifestyle","Metformin","DPPOS Boost Lifestyle","Intensive Lifestyle Group Session"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of Participants With Diabetes. — Outcomes were assessed from 1996-2020 for median follow-up of 21 years and a ma…","Prevalence of Aggregate Microvascular Complication — Outcomes were assessed from 2012-2013 (approximately 2 years).","Number of Participants With Total Cancer Except Non-melanoma Skin Cancer — Outcomes were assessed from 1996-2020 (appro…","Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiova…","Subclinical Atherosclerosis — Outcomes were assessed from 2012-2013 (approximately 2 years).","Cognitive Function — Outcomes were assessed in visit year 8 starting in 2010","Short Physical Performance Battery — Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012,…","Frailty — Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017","Mortality — Outcomes were assessed throughout follow-up from 1996 to 2019. National Death Index search conducted in 201…"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · NONE","source_has_results":true},"controlled_terms":["Diabetes Mellitus","Cancer","CVD","DPPOS Group Lifestyle","Metformin","DPPOS Boost Lifestyle","Intensive Lifestyle Group Session"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Abstract contains controlled term: metformin.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct00038727","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"1996-07-31 to 2022-04-30","comparator":"1 Original Lifestyle; 2 Original Metformin; 3 Original Placebo","confidence":"structured-source","population":"ALL · 25 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":"2026-09-25T06:10:07.402Z","intervention":["DPPOS Group Lifestyle","Metformin","DPPOS Boost Lifestyle","Intensive Lifestyle Group Session"],"participants":2779,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","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":["Number of Participants With Diabetes. — Outcomes were assessed from 1996-2020 for median follow-up of 21 years and a ma…","Prevalence of Aggregate Microvascular Complication — Outcomes were assessed from 2012-2013 (approximately 2 years).","Number of Participants With Total Cancer Except Non-melanoma Skin Cancer — Outcomes were assessed from 1996-2020 (appro…","Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiova…","Subclinical Atherosclerosis — Outcomes were assessed from 2012-2013 (approximately 2 years).","Cognitive Function — Outcomes were assessed in visit year 8 starting in 2010","Short Physical Performance Battery — Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012,…","Frailty — Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017","Mortality — Outcomes were assessed throughout follow-up from 1996 to 2019. National Death Index search conducted in 201…"],"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":["Abstract contains controlled term: metformin.","Source terminology contains: metformin.","Abstract supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["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/98","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}