Resultatstudie for diabetesforebyggende program (DPPOS)
27. juli 2026 oppdatert av: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Prevention Program (DPP) var en multisenterstudie som undersøkte evnen til en intensiv livsstil eller metformin til å forhindre eller forsinke utviklingen av diabetes i en høyrisikopopulasjon på grunn av tilstedeværelsen av nedsatt glukosetoleranse (IGT, 2 timers glukose av 140-199 mg/dl). DPP har avsluttet tidlig og viser at livsstil reduserte diabetesdebut med 58 % og metformin reduserte diabetesdebut med 31 %.
DPPOS (2002-2013) er designet for å dra nytte av de vitenskapelig og klinisk verdifulle DPP-deltakerne. Denne gruppen av deltakere utgjør nesten 50 % minoritet og representerer den største risikopopulasjonen som noen gang er studert. Klinisk viktige forskningsspørsmål gjenstår som fokuserer på 1) holdbarheten av den tidligere DPP-intervensjonen, 2) bestemmelse av det kliniske forløpet av nøyaktig kjent nyoppstått diabetes, spesielt angående mikrovaskulær sykdom, CVD-risikofaktorer og åreforkalkning, 3) nøye undersøkelse av disse temaene hos menn vs kvinner og i minoritetsbefolkninger.
Hovedmålene med DPPOS-3 (2014-2025) drar fordel av den langsiktige randomiserte eksponeringen av studiekohorten for metformin og aldring av DPPOS-kohorten. Metformineksponeringen og høy grad av studieoppbevaring og overholdelse (~85 % av DPPOS-kohorten fortsetter å delta på årlige og midtårsbesøk) gjør at DPPOS-3 kan undersøke langtidseffektene av metformin på hjerte- og karsykdommer (CVD) og kreft utfall, utfall av stor klinisk interesse og viktig.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Gjeldende DPPOS Executive Summary og protokoll, samt DPPOS-protokollen og livsstilsmanualer og -publikasjoner er tilgjengelig på: http://www.dppos.org
Studietype
Intervensjonell
Registrering (Faktiske)
2779
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Maryland
-
Rockville, Maryland, Forente stater, 20852
- George Washington University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Deltakelse som frivillig i Diabetes Prevention Program (DPP).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 1 Original livsstil
randomisert til demaskert Intensiv Lifestyle under DPP og tilbød Intensive Lifestyle Group Session, DPPOS Group Lifestyle pluss DPPOS Boost Lifestyle økter i DPPOS fase 1 og 2
|
Kvartalsvise gruppelivsstilsøkter
I tillegg til kvartalsgruppe, 2 ekstra klasser per år og en årlig 15 minutters kontroll.
16 økter pensum i gruppeformat.
I DPP levert til ILS som individuelle økter
Andre navn:
|
|
Aktiv komparator: 2 Original Metformin
randomisert til den maskerte metforminbehandlingsgruppen under DPP og fortsatt åpen etikett i DPPOS.
Deltakerne ble også tilbudt Intensiv Lifestyle Group Session, DPPOS Group Lifestyle i DPPOS fase 1 og 2.
|
Kvartalsvise gruppelivsstilsøkter
16 økter pensum i gruppeformat.
I DPP levert til ILS som individuelle økter
Andre navn:
Administrert som 850 mg to ganger per dag, maskert i DPP og åpen etikett i DPPOS
Andre navn:
|
|
Placebo komparator: 3 Original placebo
randomisert til maskert placebo under DPP og tilbudt Intensiv Lifestyle Group Session, DPPOS Group Lifestyle i DPPOS fase 1 og 2
|
Kvartalsvise gruppelivsstilsøkter
16 økter pensum i gruppeformat.
I DPP levert til ILS som individuelle økter
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomst av aggregert mikrovaskulær komplikasjon
Tidsramme: Utfall ble vurdert fra 2012-2013 (ca. 2 år).
|
Aggregert mikrovaskulær sykdom er definert som gjennomsnittlig prevalens av 3 komponenter: (1) retinopati målt ved fotografering (ETDRS på 20 eller høyere); (2) nevropati påvist av Semmes Weinstein 10 gram monofilament, og (3) nefropati basert på estimert glomerulær filtrasjonshastighet (eGFR ved kronisk nyresykdom (CKD-Epi) ligning) (<45 ml/min, bekreftet) og albumin-til- kreatininforhold i punkturin (> 30 mg/g, bekreftet).
|
Utfall ble vurdert fra 2012-2013 (ca. 2 år).
|
|
Number of Participants With Diabetes.
Tidsramme: 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.
|
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).
|
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.
|
|
Number of Participants With Total Cancer Except Non-melanoma Skin Cancer
Tidsramme: Outcomes were assessed from 1996-2020 (approximately 24 years).
|
All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
|
Outcomes were assessed from 1996-2020 (approximately 24 years).
|
|
Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subklinisk aterosklerose
Tidsramme: Utfall ble vurdert fra 2012-2013 (ca. 2 år).
|
Målt ved hjelp av koronarforkalkning (CAC).
|
Utfall ble vurdert fra 2012-2013 (ca. 2 år).
|
|
Cognitive Function
Tidsramme: Outcomes were assessed in visit year 8 starting in 2010
|
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.
|
Outcomes were assessed in visit year 8 starting in 2010
|
|
Short Physical Performance Battery
Tidsramme: Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012, and 2017, respectively
|
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.
|
Outcomes were assessed in visit years 8, 10 , and 15 which started in 2010, 2012, and 2017, respectively
|
|
Frailty
Tidsramme: Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017
|
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.
|
Outcomes were assessed in DPPOS Visits years 8, 10 and 15 which started in 2010, 2012, and 2017
|
|
Mortality
Tidsramme: 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.
|
All cause-mortality through clinic reports and National Death Index search
|
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.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Development of Diabetes by Sex
Tidsramme: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
|
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
|
Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
|
|
Development of Diabetes by Race
Tidsramme: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
|
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
|
Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
|
|
Prevalence of Aggregate Microvascular Complication by Sex
Tidsramme: Outcomes were assessed from 2012-2013 (approximately 2 years).
|
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.
|
Outcomes were assessed from 2012-2013 (approximately 2 years).
|
|
Prevalence of Aggregate Microvascular Complication by Race
Tidsramme: Outcomes were assessed from 2012-2013 (approximately 2 years).
|
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.
|
Outcomes were assessed from 2012-2013 (approximately 2 years).
|
|
Number of Participants With Total Cancer Except Non-melanoma Skin Cancer by Sex
Tidsramme: Outcomes were assessed from 1996-2020 (approximately 24 years).
|
All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
|
Outcomes were assessed from 1996-2020 (approximately 24 years).
|
|
Number of Participants With Total Cancer Except Non-melanoma Skin Cancer by Race
Tidsramme: Outcomes were assessed from 1996-2020 (approximately 24 years).
|
All primary cancers except non-melanoma skin cancer that occurred after randomization in DPP
|
Outcomes were assessed from 1996-2020 (approximately 24 years).
|
|
Number of Participants With Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) By Sex
Tidsramme: 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 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studiestol: David M. Nathan, MD, Massachusetts General Hospital
- Hovedetterforsker: Marinella Temprosa, PhD, George Washington University Biostatistics Center
- Studieleder: Barbara Linder, MD, PhD, NIDDK Project Scientist
- Hovedetterforsker: Kathleen Jablonski, PhD, George Washington University Biostatistics Center
- Hovedetterforsker: Ronald B Goldberg, MD, University of Miami
- Hovedetterforsker: Helen P Hazuda, MD, The University of Texas Health Science Center at San Antonio
- Hovedetterforsker: Dana Dabelea, MD, PhD, University of Colorado, Denver
- Hovedetterforsker: Medha Munshi, MD, Joslin Diabetes Center
- Hovedetterforsker: Steven Kahn, MB, ChB, University of Washington
- Hovedetterforsker: Happy Araneta, PhD,MPH, University of California, San Diego
- Hovedetterforsker: Karol E Watson, MD, University of California, Los Angeles
- Hovedetterforsker: Angela Brown, MD, Washington University School of Medicine
- Hovedetterforsker: Sherita Hill Golden, MD, MHS, Johns Hopkins School of Medicine
- Hovedetterforsker: David S Schade, MD, The University of New Mexico
- Hovedetterforsker: Elizabeth Venditti, PhD, University of Pittsburgh
- Hovedetterforsker: Marjerie Mau, MD, University of Hawaii
- Studieleder: Christine Lee, MD, NIDDK Project Scientist
- Hovedetterforsker: Sunder Mudaliar, MD, University of California, San Diego
- Hovedetterforsker: Amisha Wallia, MD, Northwestern University
- Hovedetterforsker: Jill Crandall, MD, Albert Einstein College of Medicine
- Hovedetterforsker: Celeste Thomas, MD, University of Chicago
- Hovedetterforsker: Owen Carmichael, PhD, Pennington Biomedical Research Center
- Hovedetterforsker: Intekhab Ahmed, MD, Jefferson Medical College of Thomas Jefferson University
- Hovedetterforsker: Samuel Dagogo-Jack, MD, MB, University of Tennessee
- Hovedetterforsker: Blandine Laferrere, MD, Columbia University
- Hovedetterforsker: Mary de Groot, PhD, Indiana University
- Hovedetterforsker: Saurabh Sharma, MD, Medstar Health Research Institute
- Hovedetterforsker: Robert Hanson, MD, SW Indian Center - Phoenix
- Hovedetterforsker: Linda Delahanty, MD, Massachusetts General Hospital
- Hovedetterforsker: Vallabh Shah, PhD, SW Indian Center - Zuni/Shiprock
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
31. juli 1996
Primær fullføring (Faktiske)
28. februar 2020
Studiet fullført (Faktiske)
30. april 2022
Datoer for studieregistrering
Først innsendt
4. juni 2002
Først innsendt som oppfylte QC-kriteriene
4. juni 2002
Først lagt ut (Antatt)
5. juni 2002
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Ernæringsforstyrrelser
- Metabolske sykdommer
- Overernæring
- Kroppsvekt
- Glukosemetabolismeforstyrrelser
- Overvektig
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Neoplasmer
- Overvekt
- Diabetes mellitus, type 2
- Sukkersyke
- Prediabetisk tilstand
- Organiske kjemikalier
- Biguanider
- Guanidiner
- Amidines
- Metformin
Andre studie-ID-numre
- DPPOS
- U01DK048489 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository
IPD-delingstidsramme
2002-2025
Tilgangskriterier for IPD-deling
Instruksjoner for tilgang er detaljert her: https://repository.niddk.nih.gov/pages/overall_instructions/
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .