Studio sui risultati del programma di prevenzione del diabete (DPPOS)
27 luglio 2026 aggiornato da: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Il Diabetes Prevention Program (DPP) era uno studio multicentrico che esaminava la capacità di uno stile di vita intensivo o di metformina di prevenire o ritardare lo sviluppo del diabete in una popolazione ad alto rischio a causa della presenza di ridotta tolleranza al glucosio (IGT, glucosio a 2 ore di 140-199 mg/dl). Il DPP ha concluso in anticipo dimostrando che lo stile di vita ha ridotto l'insorgenza del diabete del 58% e la metformina ha ridotto l'insorgenza del diabete del 31%.
DPPOS (2002-2013) è progettato per sfruttare i partecipanti DPP di valore scientifico e clinico. Questo gruppo di partecipanti è quasi il 50% di minoranza e rappresenta la più grande popolazione a rischio mai studiata. Rimangono questioni di ricerca clinicamente importanti che si concentrano su 1) durata del precedente intervento DPP, 2) determinazione del decorso clinico del diabete di nuova insorgenza noto con precisione, in particolare per quanto riguarda la malattia microvascolare, i fattori di rischio CVD e l'aterosclerosi, 3) un attento esame di questi argomenti negli uomini rispetto alle donne e nelle popolazioni minoritarie.
Gli obiettivi principali di DPPOS-3 (2014-2025) sfruttano l'esposizione randomizzata a lungo termine della coorte dello studio alla metformina e l'invecchiamento della coorte DPPOS. L'esposizione alla metformina e l'elevato grado di ritenzione e aderenza allo studio (~ l'85% della coorte DPPOS continua a partecipare a visite annuali e di metà anno) consente a DPPOS-3 di esaminare gli effetti a lungo termine della metformina sulle malattie cardiovascolari (CVD) e sul cancro esiti, esiti di grande interesse clinico e di grande importanza.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
L'attuale sintesi e protocollo esecutivo DPPOS, nonché il protocollo DPPOS e i manuali e le pubblicazioni sullo stile di vita sono disponibili all'indirizzo: http://www.dppos.org
Tipo di studio
Interventistico
Iscrizione (Effettivo)
2779
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Maryland
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Rockville, Maryland, Stati Uniti, 20852
- George Washington University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
25 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Descrizione
Partecipazione come volontario al Programma di Prevenzione del Diabete (DPP).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 1 stile di vita originale
randomizzato allo stile di vita intensivo smascherato durante il DPP e ha offerto sessioni di gruppo di stile di vita intensivo, stile di vita di gruppo DPPOS più sessioni di stile di vita Boost DPPOS nelle fasi 1 e 2 di DPPOS
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Sessioni trimestrali sullo stile di vita di gruppo
Oltre al gruppo trimestrale, 2 lezioni aggiuntive all'anno e un check-up annuale di 15 minuti.
Curriculum di 16 sessioni in formato di gruppo.
In DPP consegnato a ILS come sessioni individuali
Altri nomi:
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Comparatore attivo: 2 metformina originale
randomizzato al gruppo di trattamento con metformina in maschera durante DPP e continuato in aperto in DPPOS.
Ai partecipanti è stata anche offerta una sessione di gruppo sullo stile di vita intensivo, lo stile di vita di gruppo DPPOS nelle fasi 1 e 2 di DPPOS.
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Sessioni trimestrali sullo stile di vita di gruppo
Curriculum di 16 sessioni in formato di gruppo.
In DPP consegnato a ILS come sessioni individuali
Altri nomi:
Somministrato come 850 mg due volte al giorno, mascherato in DPP e in aperto in DPPOS
Altri nomi:
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Comparatore placebo: 3 placebo originale
randomizzato al placebo mascherato durante il DPP e offerto sessione di gruppo sullo stile di vita intensivo, stile di vita di gruppo DPPOS nella fase 1 e 2 di DPPOS
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Sessioni trimestrali sullo stile di vita di gruppo
Curriculum di 16 sessioni in formato di gruppo.
In DPP consegnato a ILS come sessioni individuali
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Prevalenza di complicanze microvascolari aggregate
Lasso di tempo: I risultati sono stati valutati dal 2012 al 2013 (circa 2 anni).
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La malattia microvascolare aggregata è definita come la prevalenza media di 3 componenti: (1) retinopatia misurata dalla fotografia (ETDRS di 20 o superiore); (2) neuropatia rilevata dal monofilamento da 10 grammi di Semmes Weinstein e (3) nefropatia basata sulla velocità di filtrazione glomerulare stimata (eGFR secondo l'equazione della malattia renale cronica (CKD-Epi)) (<45 ml/min, confermata) e albumina-to- rapporto della creatinina nelle urine spot (> 30 mg/gm, confermato).
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I risultati sono stati valutati dal 2012 al 2013 (circa 2 anni).
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Number of Participants With Diabetes.
Lasso di tempo: Outcomes were assessed from 1996-2020 for median follow-up of 21 years and a maximum follow-up of 23 years including a median of 3 years in DPP in all participants enrolled in DPPOS.
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Primary outcome defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).
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Outcomes were assessed from 1996-2020 for median follow-up of 21 years and a maximum follow-up of 23 years including a median of 3 years in DPP in all participants enrolled in DPPOS.
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Number of Participants With Total Cancer Except Non-melanoma Skin Cancer
Lasso di tempo: Outcomes were assessed from 1996-2020 (approximately 24 years).
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All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
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Outcomes were assessed from 1996-2020 (approximately 24 years).
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Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
Lasso di tempo: Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
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Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Aterosclerosi subclinica
Lasso di tempo: I risultati sono stati valutati dal 2012 al 2013 (circa 2 anni).
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Misurato mediante calcificazione dell'arteria coronaria (CAC).
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I risultati sono stati valutati dal 2012 al 2013 (circa 2 anni).
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Cognitive Function
Lasso di tempo: Outcomes were assessed in visit year 8 starting in 2010
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Cognitive function was defined by tests of memory SEVLT (Spanish English Verbal Learning Test) and executive function, DSST (Digit Symbol Substitution Test).
The measure of memory was the Spanish English Verbal Learning Test (SEVLT).
The SEVLT consists of recalling a list of 15 words in three trials of immediate recall and one trial after a distractor list.
The total number of correct words recalled after four trials is the outcome reported.The test of frontal-executive abilities was the total score in the Digit Symbol Substitution Test (DSST).
The DSST is a test in which participants try to match numbers to symbols in 90 s.
The total number of correct answers is reported.
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Outcomes were assessed in visit year 8 starting in 2010
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Short Physical Performance Battery
Lasso di tempo: Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012, and 2017, respectively
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Physical function is measured using the short physical performance battery (SPPB), which ranges from 0-12 and is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands and derived as SPPB= (balance score + gait score + chair score).
Each sub scale is 0, 1, 2, 3 or 4 depending on the gender specific quintiles with 0 being the lowest and 4 being the highest functional status as described in Guralnik JM, Simonsick EM, Ferrucci L, et al.
A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission.
J Gerontol.
1994 Mar 1;49(2):M85-94.
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Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012, and 2017, respectively
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Frailty
Lasso di tempo: Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017
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Description: The Cardiovascular Health Study Frailty score is based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.
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Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017
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Mortality
Lasso di tempo: Outcomes were assessed throughout follow-up from 1996 to 2019. National Death Index search conducted in 2019 using early release data as of Dec 2018.
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All cause-mortality through clinic reports and National Death Index search
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Outcomes were assessed throughout follow-up from 1996 to 2019. National Death Index search conducted in 2019 using early release data as of Dec 2018.
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Development of Diabetes by Sex
Lasso di tempo: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
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Primary outcome defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).
Stratified by sex among DPP participants who enrolled in DPPOS 2002-2008
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Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
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Development of Diabetes by Race
Lasso di tempo: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
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Primary outcome defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).
Stratified by race among DPP participants who enrolled in DPPOS 2002-2008
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Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
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Prevalence of Aggregate Microvascular Complication by Sex
Lasso di tempo: Outcomes were assessed from 2012-2013 (approximately 2 years).
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Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).
General estimating equation models (GEE) were used to estimate average (marginal) prevalence accounting for correlations among the 3 components.
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Outcomes were assessed from 2012-2013 (approximately 2 years).
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Prevalence of Aggregate Microvascular Complication by Race
Lasso di tempo: Outcomes were assessed from 2012-2013 (approximately 2 years).
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Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).
General estimating equation models (GEE) were used to estimate average (marginal) prevalence accounting for correlations among the 3 components.
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Outcomes were assessed from 2012-2013 (approximately 2 years).
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Number of Participants With Total Cancer Except Non-melanoma Skin Cancer by Sex
Lasso di tempo: Outcomes were assessed from 1996-2020 (approximately 24 years).
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All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
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Outcomes were assessed from 1996-2020 (approximately 24 years).
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Number of Participants With Total Cancer Except Non-melanoma Skin Cancer by Race
Lasso di tempo: Outcomes were assessed from 1996-2020 (approximately 24 years).
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All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
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Outcomes were assessed from 1996-2020 (approximately 24 years).
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Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) By Sex
Lasso di tempo: Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment stratified by sex
|
Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
|
|
Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) By Race
Lasso di tempo: Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
|
MACE includes MI, stroke or CVD death that occurred after randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
|
Outcomes were assessed from 1996-2019 over a total median follow-up of 21 years since DPP randomization
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Cattedra di studio: David M. Nathan, MD, Massachusetts General Hospital
- Investigatore principale: Marinella Temprosa, PhD, George Washington University Biostatistics Center
- Direttore dello studio: Barbara Linder, MD, PhD, NIDDK Project Scientist
- Investigatore principale: Kathleen Jablonski, PhD, George Washington University Biostatistics Center
- Investigatore principale: Ronald B Goldberg, MD, University of Miami
- Investigatore principale: Helen P Hazuda, MD, The University of Texas Health Science Center at San Antonio
- Investigatore principale: Dana Dabelea, MD, PhD, University of Colorado, Denver
- Investigatore principale: Medha Munshi, MD, Joslin Diabetes Center
- Investigatore principale: Steven Kahn, MB, ChB, University of Washington
- Investigatore principale: Happy Araneta, PhD,MPH, University of California, San Diego
- Investigatore principale: Karol E Watson, MD, University of California, Los Angeles
- Investigatore principale: Angela Brown, MD, Washington University School of Medicine
- Investigatore principale: Sherita Hill Golden, MD, MHS, Johns Hopkins School of Medicine
- Investigatore principale: David S Schade, MD, The University of New Mexico
- Investigatore principale: Elizabeth Venditti, PhD, University of Pittsburgh
- Investigatore principale: Marjerie Mau, MD, University of Hawaii
- Direttore dello studio: Christine Lee, MD, NIDDK Project Scientist
- Investigatore principale: Sunder Mudaliar, MD, University of California, San Diego
- Investigatore principale: Amisha Wallia, MD, Northwestern University
- Investigatore principale: Jill Crandall, MD, Albert Einstein College of Medicine
- Investigatore principale: Celeste Thomas, MD, University of Chicago
- Investigatore principale: Owen Carmichael, PhD, Pennington Biomedical Research Center
- Investigatore principale: Intekhab Ahmed, MD, Jefferson Medical College of Thomas Jefferson University
- Investigatore principale: Samuel Dagogo-Jack, MD, MB, University of Tennessee
- Investigatore principale: Blandine Laferrere, MD, Columbia University
- Investigatore principale: Mary de Groot, PhD, Indiana University
- Investigatore principale: Saurabh Sharma, MD, Medstar Health Research Institute
- Investigatore principale: Robert Hanson, MD, SW Indian Center - Phoenix
- Investigatore principale: Linda Delahanty, MD, Massachusetts General Hospital
- Investigatore principale: Vallabh Shah, PhD, SW Indian Center - Zuni/Shiprock
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015 Nov;3(11):866-75. doi: 10.1016/S2213-8587(15)00291-0. Epub 2015 Sep 13.
- Shams-White MM, Tjaden AH, Edelstein SL, Bassiouni S, Kahle LL, Kim C, Pi-Sunyer X, Temple KA, Venditti EM, Reedy J, Heckman-Stoddard BM; DPP Research Group. The 2018 World Cancer Research Fund (WCRF)/American Institute for Cancer Research (AICR) score and diabetes risk in the Diabetes Prevention Program Outcomes Study (DPPOS). BMC Nutr. 2022 Sep 21;8(1):105. doi: 10.1186/s40795-022-00596-7.
- Goldberg RB, Orchard TJ, Crandall JP, Boyko EJ, Budoff M, Dabelea D, Gadde KM, Knowler WC, Lee CG, Nathan DM, Watson K, Temprosa M; Diabetes Prevention Program Research Group*. Effects of Long-term Metformin and Lifestyle Interventions on Cardiovascular Events in the Diabetes Prevention Program and Its Outcome Study. Circulation. 2022 May 31;145(22):1632-1641. doi: 10.1161/CIRCULATIONAHA.121.056756. Epub 2022 May 23.
- Lee CG, Heckman-Stoddard B, Dabelea D, Gadde KM, Ehrmann D, Ford L, Prorok P, Boyko EJ, Pi-Sunyer X, Wallia A, Knowler WC, Crandall JP, Temprosa M; Diabetes Prevention Program Research Group; Diabetes Prevention Program Research Group:. Effect of Metformin and Lifestyle Interventions on Mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2021 Dec;44(12):2775-2782. doi: 10.2337/dc21-1046. Epub 2021 Oct 25.
- Varga TV, Liu J, Goldberg RB, Chen G, Dagogo-Jack S, Lorenzo C, Mather KJ, Pi-Sunyer X, Brunak S, Temprosa M; Diabetes Prevention Program Research Group. Predictive utilities of lipid traits, lipoprotein subfractions and other risk factors for incident diabetes: a machine learning approach in the Diabetes Prevention Program. BMJ Open Diabetes Res Care. 2021 Mar;9(1):e001953. doi: 10.1136/bmjdrc-2020-001953.
- Kriska AM, Rockette-Wagner B, Edelstein SL, Bray GA, Delahanty LM, Hoskin MA, Horton ES, Venditti EM, Knowler WC; DPP Research Group. The Impact of Physical Activity on the Prevention of Type 2 Diabetes: Evidence and Lessons Learned From the Diabetes Prevention Program, a Long-Standing Clinical Trial Incorporating Subjective and Objective Activity Measures. Diabetes Care. 2021 Jan;44(1):43-49. doi: 10.2337/dc20-1129. Epub 2020 Nov 10.
- Hazuda HP, Pan Q, Florez H, Luchsinger JA, Crandall JP, Venditti EM, Golden SH, Kriska AM, Bray GA. Association of Intensive Lifestyle and Metformin Interventions With Frailty in the Diabetes Prevention Program Outcomes Study. J Gerontol A Biol Sci Med Sci. 2021 Apr 30;76(5):929-936. doi: 10.1093/gerona/glaa295.
- Perreault L, Pan Q, Schroeder EB, Kalyani RR, Bray GA, Dagogo-Jack S, White NH, Goldberg RB, Kahn SE, Knowler WC, Mathioudakis N, Dabelea D; Diabetes Prevention Program Research Group. Regression From Prediabetes to Normal Glucose Regulation and Prevalence of Microvascular Disease in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabetes Care. 2019 Sep;42(9):1809-1815. doi: 10.2337/dc19-0244. Epub 2019 Jul 18.
- Cardenas A, Hivert MF, Gold DR, Hauser R, Kleinman KP, Lin PD, Fleisch AF, Calafat AM, Ye X, Webster TF, Horton ES, Oken E. Associations of Perfluoroalkyl and Polyfluoroalkyl Substances With Incident Diabetes and Microvascular Disease. Diabetes Care. 2019 Sep;42(9):1824-1832. doi: 10.2337/dc18-2254. Epub 2019 Jul 11.
- Diabetes Prevention Program Research Group. Long-term Effects of Metformin on Diabetes Prevention: Identification of Subgroups That Benefited Most in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2019 Apr;42(4):601-608. doi: 10.2337/dc18-1970.
- Cardenas A, Hauser R, Gold DR, Kleinman KP, Hivert MF, Fleisch AF, Lin PD, Calafat AM, Webster TF, Horton ES, Oken E. Association of Perfluoroalkyl and Polyfluoroalkyl Substances With Adiposity. JAMA Netw Open. 2018 Aug 3;1(4):e181493. doi: 10.1001/jamanetworkopen.2018.1493.
- Kim C, Ricardo AC, Boyko EJ, Christophi CA, Temprosa M, Watson KE, Pi-Sunyer X, Kalyani RR; Diabetes Prevention Program Research Group. Sex Hormones and Measures of Kidney Function in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1171-1180. doi: 10.1210/jc.2018-01495.
- DeBoer MD, Filipp SL, Gurka MJ. Use of a Metabolic Syndrome Severity Z Score to Track Risk During Treatment of Prediabetes: An Analysis of the Diabetes Prevention Program. Diabetes Care. 2018 Nov;41(11):2421-2430. doi: 10.2337/dc18-1079. Epub 2018 Oct 1.
- Kim C, Aroda VR, Goldberg RB, Younes N, Edelstein SL, Carrion-Petersen M, Ehrmann DA; Diabetes Prevention Program Outcomes Study Group. Androgens, Irregular Menses, and Risk of Diabetes and Coronary Artery Calcification in the Diabetes Prevention Program. J Clin Endocrinol Metab. 2018 Feb 1;103(2):486-496. doi: 10.1210/jc.2017-01829.
- Perreault L, Pan Q, Aroda VR, Barrett-Connor E, Dabelea D, Dagogo-Jack S, Hamman RF, Kahn SE, Mather KJ, Knowler WC; Diabetes Prevention Program Research Group. Exploring residual risk for diabetes and microvascular disease in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabet Med. 2017 Dec;34(12):1747-1755. doi: 10.1111/dme.13453. Epub 2017 Sep 19.
- Aroda VR, Knowler WC, Crandall JP, Perreault L, Edelstein SL, Jeffries SL, Molitch ME, Pi-Sunyer X, Darwin C, Heckman-Stoddard BM, Temprosa M, Kahn SE, Nathan DM; Diabetes Prevention Program Research Group. Metformin for diabetes prevention: insights gained from the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study. Diabetologia. 2017 Sep;60(9):1601-1611. doi: 10.1007/s00125-017-4361-9. Epub 2017 Aug 2.
- Kim C, Dabelea D, Kalyani RR, Christophi CA, Bray GA, Pi-Sunyer X, Darwin CH, Yalamanchi S, Barrett-Connor E, Golden SH, Boyko EJ. Changes in Visceral Adiposity, Subcutaneous Adiposity, and Sex Hormones in the Diabetes Prevention Program. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3381-3389. doi: 10.1210/jc.2017-00967.
- Luchsinger JA, Ma Y, Christophi CA, Florez H, Golden SH, Hazuda H, Crandall J, Venditti E, Watson K, Jeffries S, Manly JJ, Pi-Sunyer FX; Diabetes Prevention Program Research Group. Metformin, Lifestyle Intervention, and Cognition in the Diabetes Prevention Program Outcomes Study. Diabetes Care. 2017 Jul;40(7):958-965. doi: 10.2337/dc16-2376. Epub 2017 May 12.
- Goldberg RB, Aroda VR, Bluemke DA, Barrett-Connor E, Budoff M, Crandall JP, Dabelea D, Horton ES, Mather KJ, Orchard TJ, Schade D, Watson K, Temprosa M; Diabetes Prevention Program Research Group. Effect of Long-Term Metformin and Lifestyle in the Diabetes Prevention Program and Its Outcome Study on Coronary Artery Calcium. Circulation. 2017 Jul 4;136(1):52-64. doi: 10.1161/CIRCULATIONAHA.116.025483. Epub 2017 May 5.
- Aroda VR, Edelstein SL, Goldberg RB, Knowler WC, Marcovina SM, Orchard TJ, Bray GA, Schade DS, Temprosa MG, White NH, Crandall JP; Diabetes Prevention Program Research Group. Long-term Metformin Use and Vitamin B12 Deficiency in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab. 2016 Apr;101(4):1754-61. doi: 10.1210/jc.2015-3754. Epub 2016 Feb 22.
- Herman WH. The cost-effectiveness of diabetes prevention: results from the Diabetes Prevention Program and the Diabetes Prevention Program Outcomes Study. Clin Diabetes Endocrinol. 2015 Sep 2;1:9. doi: 10.1186/s40842-015-0009-1. eCollection 2015.
- Marrero DG, Ma Y, de Groot M, Horton ES, Price DW, Barrett-Connor E, Carnethon MR, Knowler WC; Diabetes Prevention Program Research Group. Depressive symptoms, antidepressant medication use, and new onset of diabetes in participants of the diabetes prevention program and the diabetes prevention program outcomes study. Psychosom Med. 2015 Apr;77(3):303-10. doi: 10.1097/PSY.0000000000000156.
- Aroda VR, Christophi CA, Edelstein SL, Zhang P, Herman WH, Barrett-Connor E, Delahanty LM, Montez MG, Ackermann RT, Zhuo X, Knowler WC, Ratner RE; Diabetes Prevention Program Research Group. The effect of lifestyle intervention and metformin on preventing or delaying diabetes among women with and without gestational diabetes: the Diabetes Prevention Program outcomes study 10-year follow-up. J Clin Endocrinol Metab. 2015 Apr;100(4):1646-53. doi: 10.1210/jc.2014-3761. Epub 2015 Feb 23.
- Diabetes Prevention Program Research Group. HbA1c as a predictor of diabetes and as an outcome in the diabetes prevention program: a randomized clinical trial. Diabetes Care. 2015 Jan;38(1):51-8. doi: 10.2337/dc14-0886. Epub 2014 Oct 21.
- Dabelea D, Ma Y, Knowler WC, Marcovina S, Saudek CD, Arakaki R, White NH, Kahn SE, Orchard TJ, Goldberg R, Palmer J, Hamman RF; Diabetes Prevention Program Research Group. Diabetes autoantibodies do not predict progression to diabetes in adults: the Diabetes Prevention Program. Diabet Med. 2014 Sep;31(9):1064-8. doi: 10.1111/dme.12437. Epub 2014 Apr 9.
- Marrero D, Pan Q, Barrett-Connor E, de Groot M, Zhang P, Percy C, Florez H, Ackermann R, Montez M, Rubin RR; DPPOS Research Group. Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study. Qual Life Res. 2014 Feb;23(1):75-88. doi: 10.1007/s11136-013-0436-3. Epub 2013 May 26.
- Price DW, Ma Y, Rubin RR, Perreault L, Bray GA, Marrero D, Knowler WC, Barrett-Connor E, Lacoursiere DY; Diabetes Prevention Program Research Group. Depression as a predictor of weight regain among successful weight losers in the diabetes prevention program. Diabetes Care. 2013 Feb;36(2):216-21. doi: 10.2337/dc12-0293. Epub 2012 Sep 21.
- Perreault L, Pan Q, Mather KJ, Watson KE, Hamman RF, Kahn SE; Diabetes Prevention Program Research Group. Effect of regression from prediabetes to normal glucose regulation on long-term reduction in diabetes risk: results from the Diabetes Prevention Program Outcomes Study. Lancet. 2012 Jun 16;379(9833):2243-51. doi: 10.1016/S0140-6736(12)60525-X. Epub 2012 Jun 9.
- Mather KJ, Christophi CA, Jablonski KA, Knowler WC, Goldberg RB, Kahn SE, Spector T, Dastani Z, Waterworth D, Richards JB, Funahashi T, Pi-Sunyer FX, Pollin TI, Florez JC, Franks PW; Diabetes Prevention Program Research Group. Common variants in genes encoding adiponectin (ADIPOQ) and its receptors (ADIPOR1/2), adiponectin concentrations, and diabetes incidence in the Diabetes Prevention Program. Diabet Med. 2012 Dec;29(12):1579-88. doi: 10.1111/j.1464-5491.2012.03662.x.
- Diabetes Prevention Program Research Group. Long-term safety, tolerability, and weight loss associated with metformin in the Diabetes Prevention Program Outcomes Study. Diabetes Care. 2012 Apr;35(4):731-7. doi: 10.2337/dc11-1299.
- Rubin RR, Ma Y, Peyrot M, Marrero DG, Price DW, Barrett-Connor E, Knowler WC; Diabetes Prevention Program Research Group. Antidepressant medicine use and risk of developing diabetes during the diabetes prevention program and diabetes prevention program outcomes study. Diabetes Care. 2010 Dec;33(12):2549-51. doi: 10.2337/dc10-1033. Epub 2010 Aug 30.
- Crandall JP, Polsky S, Howard AA, Perreault L, Bray GA, Barrett-Connor E, Brown-Friday J, Whittington T, Foo S, Ma Y, Edelstein SL; Diabetes Prevention Program Research Group. Alcohol consumption and diabetes risk in the Diabetes Prevention Program. Am J Clin Nutr. 2009 Sep;90(3):595-601. doi: 10.3945/ajcn.2008.27382. Epub 2009 Jul 29.
- Diabetes Prevention Program (DPP) Research Group; Hamman RF, Horton E, Barrett-Connor E, Bray GA, Christophi CA, Crandall J, Florez JC, Fowler S, Goldberg R, Kahn SE, Knowler WC, Lachin JM, Murphy MB, Venditti E. Factors affecting the decline in incidence of diabetes in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabetes. 2015 Mar;64(3):989-98. doi: 10.2337/db14-0333. Epub 2014 Oct 2.
- Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29.
- Salive ME, Tjaden AH, Ames JR, Crandall JP, Dabelea D, Hazuda HP, Heckman-Stoddard BM, Huckfeldt PJ, Kuo S, Strotmeyer ES, Temprosa M, Venditti EM; DPP Research Group. Lifestyle and Metformin Interventions and Risk of Multimorbidity in Adults With Prediabetes. JAMA. 2026 Jun 15:e268492. doi: 10.1001/jama.2026.8492. Online ahead of print.
- Lin PD, Cardenas A, Temprosa M, Botelho JC, Calafat AM, Gold DR, Oken E, Fleisch AF. Associations of Perfluoroalkyl and Polyfluoroalkyl Substances With Cardiovascular Disease Incidence in Adults With Prediabetes: Findings From the Diabetes Prevention Program. J Am Heart Assoc. 2026 Jan 6;15(1):e046298. doi: 10.1161/JAHA.125.046298. Epub 2025 Dec 18.
- Tjaden AH, Goldbaum AA, Edelstein SL, Heckman-Stoddard BM, Reedy J, Herman WH, Hoskin M, Knowler WC, Schlogl M, Temple KA, Venditti EM, Watson K, Temprosa M, Shams-White MM; DPP Research Group. The 2018 World Cancer Research Fund/American Institute for Cancer Research Score and Cancer Risk: results from the diabetes prevention program outcomes study. Am J Clin Nutr. 2025 Sep;122(3):715-723. doi: 10.1016/j.ajcnut.2025.07.011. Epub 2025 Jul 15.
- Knowler WC, Doherty L, Edelstein SL, Bennett PH, Dabelea D, Hoskin M, Kahn SE, Kalyani RR, Kim C, Pi-Sunyer FX, Raghavan S, Shah VO, Temprosa M, Venditti EM, Nathan DM; DPP/DPPOS Research Group. Long-term effects and effect heterogeneity of lifestyle and metformin interventions on type 2 diabetes incidence over 21 years in the US Diabetes Prevention Program randomised clinical trial. Lancet Diabetes Endocrinol. 2025 Jun;13(6):469-481. doi: 10.1016/S2213-8587(25)00022-1. Epub 2025 Apr 28.
- Munshi MN, Venditti EM, Tjaden AH, Knowler WC, Boyko EJ, Middelbeek RJW, Luchsinger JA, Lee CG, Hazuda HP, Salive ME, Edelstein SL, Storer TW. Long-term impact of Diabetes Prevention Program interventions on walking endurance. Front Public Health. 2024 Dec 18;12:1470035. doi: 10.3389/fpubh.2024.1470035. eCollection 2024.
- Gadde KM, Yin X, Goldberg RB, Orchard TJ, Schlogl M, Dabelea D, Ibebuogu UN, Watson KE, Pi-Sunyer FX, Crandall JP, Temprosa M, Luchsinger JA; Diabetes Prevention Program Research Group. Coronary Artery Calcium and Cognitive Decline in the Diabetes Prevention Program Outcomes Study. J Am Heart Assoc. 2023 Nov 7;12(21):e029671. doi: 10.1161/JAHA.123.029671. Epub 2023 Nov 6.
- Molitch ME, Tripputi M, Levey AS, Crandall JP, Dabelea D, Herman WH, Knowler WC, Orchard TJ, Schroeder EB, Srikanthan P, Temprosa M, White NH, Nathan DM; Diabetes Prevention Program Research Group. Electronic address: dppmail@bsc.gwu.edu. Effects of metformin and intensive lifestyle interventions on the incidence of kidney disease in adults in the DPP/DPPOS. J Diabetes Complications. 2023 Sep;37(9):108556. doi: 10.1016/j.jdiacomp.2023.108556. Epub 2023 Jul 25.
- Kim C, Younes N, Temprosa M, Edelstein S, Goldberg RB, Araneta MG, Wallia A, Brown A, Darwin C, Ibebuogu U, Pi-Sunyer X, Knowler WC. Infertility, Gravidity, and Risk Of Diabetes among High-Risk Women in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e358-67. doi: 10.1210/clinem/dgaa013.
- Apolzan JW, Venditti EM, Edelstein SL, Knowler WC, Dabelea D, Boyko EJ, Pi-Sunyer X, Kalyani RR, Franks PW, Srikanthan P, Gadde KM; Diabetes Prevention Program Research Group. Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study. Ann Intern Med. 2019 May 21;170(10):682-690. doi: 10.7326/M18-1605. Epub 2019 Apr 23.
- Crandall JP, Mather K, Rajpathak SN, Goldberg RB, Watson K, Foo S, Ratner R, Barrett-Connor E, Temprosa M. Statin use and risk of developing diabetes: results from the Diabetes Prevention Program. BMJ Open Diabetes Res Care. 2017 Oct 10;5(1):e000438. doi: 10.1136/bmjdrc-2017-000438. eCollection 2017.
- Diabetes Prevention Program Outcomes Study Research Group; Orchard TJ, Temprosa M, Barrett-Connor E, Fowler SE, Goldberg RB, Mather KJ, Marcovina SM, Montez M, Ratner RE, Saudek CD, Sherif H, Watson KE. Long-term effects of the Diabetes Prevention Program interventions on cardiovascular risk factors: a report from the DPP Outcomes Study. Diabet Med. 2013 Jan;30(1):46-55. doi: 10.1111/j.1464-5491.2012.03750.x.
- Diabetes Prevention Program Research Group. The 10-year cost-effectiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care. 2012 Apr;35(4):723-30. doi: 10.2337/dc11-1468.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
31 luglio 1996
Completamento primario (Effettivo)
28 febbraio 2020
Completamento dello studio (Effettivo)
30 aprile 2022
Date di iscrizione allo studio
Primo inviato
4 giugno 2002
Primo inviato che soddisfa i criteri di controllo qualità
4 giugno 2002
Primo Inserito (Stimato)
5 giugno 2002
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Disturbi della nutrizione
- Malattie metaboliche
- Ipernutrizione
- Peso corporeo
- Disturbi del metabolismo del glucosio
- Sovrappeso
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Segni e sintomi
- Neoplasie
- Obesità
- Diabete mellito, tipo 2
- Diabete mellito
- Stato prediabetico
- Prodotti chimici organici
- Biguanides
- Guanidine
- Amidine
- Metformina
Altri numeri di identificazione dello studio
- DPPOS
- U01DK048489 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Repository del National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Periodo di condivisione IPD
2002-2025
Criteri di accesso alla condivisione IPD
Le istruzioni per l'accesso sono dettagliate qui: https://repository.niddk.nih.gov/pages/overall_instructions/
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .