NCT00004992

Brief Summary

The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,234

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 1996

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2000

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

4.8 years

First QC Date

March 17, 2000

Last Update Submit

February 28, 2018

Conditions

Diabetes Mellitus, Non-Insulin-DependentGlucose Intolerance

Keywords

clinical trialmulti-centerNIDDMNIDDKDiabetes Prevention Program (DPP)diabetes risk factorsdiabetesglycemiacardiovascular risk factorsquality of lifephysical activity and nutritionoccurrence of adverse eventsinsulin secretion and sensitivitypreventionabnormal glucose metabolismlifestyle interventiondrug intervention

Outcome Measures

Primary Outcomes (1)

  • Development of diabetes

    Diabetes was diagnosed on the basis of an annual oral glucose-tolerance test or a semiannual fasting plasma glucose test, according to the 1997 criteria of the American Diabetes Association

    Up to 5 years

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Metformin

ACTIVE COMPARATOR
Drug: Metformin

Intensive Lifestyle

ACTIVE COMPARATOR
Behavioral: Intensive lifestyle

Interventions

Intensive lifestyleBEHAVIORAL
Intensive Lifestyle
MetforminDRUG
Metformin
PlaceboDRUG
Placebo

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)
  • BMI \>= 24 kg/m2

You may not qualify if:

  • Underlying disease likely to limit life span and/or increase risk of interventions
  • Conditions or behaviors likely to effect conduct of the DPP
  • Diabetes or disordered glucose metabolism
  • Suboptimally treated Thyroid disease
  • Fasting triglyceride level \< 600 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd

Rockville, Maryland, 20852, United States

Location

Related Publications (63)

  • Florez JC, Jablonski KA, Bayley N, Pollin TI, de Bakker PI, Shuldiner AR, Knowler WC, Nathan DM, Altshuler D; Diabetes Prevention Program Research Group. TCF7L2 polymorphisms and progression to diabetes in the Diabetes Prevention Program. N Engl J Med. 2006 Jul 20;355(3):241-50. doi: 10.1056/NEJMoa062418.

    PMID: 16855264RESULT

  • 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.

    PMID: 11832527RESULT

  • 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.

    PMID: 41413398DERIVED

  • 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.

    PMID: 40675492DERIVED

  • 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.

    PMID: 40311647DERIVED

  • 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.

    PMID: 39744353DERIVED

  • 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.

    PMID: 37607422DERIVED

  • 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.

    PMID: 36131333DERIVED

  • Vazquez Arreola E, Knowler WC, Hanson RL. Weight Loss, Lifestyle Intervention, and Metformin Affect Longitudinal Relationship of Insulin Secretion and Sensitivity. J Clin Endocrinol Metab. 2022 Nov 23;107(11):3086-3099. doi: 10.1210/clinem/dgac509.

    PMID: 36062951DERIVED

  • 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.

    PMID: 35603600DERIVED

  • Wander PL, Christophi CA, Araneta MRG, Boyko EJ, Enquobahrie DA, Dabelea D, Goldberg RB, Kahn SE, Kim C, Pi-Sunyer X, Knowler WC. Adiposity, related biomarkers, and type 2 diabetes after gestational diabetes: The Diabetes Prevention Program. Obesity (Silver Spring). 2022 Jan;30(1):221-228. doi: 10.1002/oby.23291. Epub 2021 Nov 18.

    PMID: 34796678DERIVED

  • 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.

    PMID: 34697033DERIVED

  • 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.

    PMID: 33789908DERIVED

  • Goldberg RB, Tripputi MT, Boyko EJ, Budoff M, Chen ZZ, Clark JM, Dabelea DM, Edelstein SL, Gerszten RE, Horton E, Mather KJ, Perreault L, Temprosa M, Wallia A, Watson K, Irfan Z. Hepatic Fat in Participants With and Without Incident Diabetes in the Diabetes Prevention Program Outcome Study. J Clin Endocrinol Metab. 2021 Oct 21;106(11):e4746-e4765. doi: 10.1210/clinem/dgab160.

    PMID: 33705543DERIVED

  • 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.

    PMID: 33444158DERIVED

  • 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.

    PMID: 33428709DERIVED

  • Gupta DK, Walford GA, Ma Y, Jarolim P, Wang TJ; DPP Research Group. Racial/ethnic differences in circulating natriuretic peptide levels: The Diabetes Prevention Program. PLoS One. 2020 Feb 21;15(2):e0229280. doi: 10.1371/journal.pone.0229280. eCollection 2020.

    PMID: 32084251DERIVED

  • Merino J, Jablonski KA, Mercader JM, Kahn SE, Chen L, Harden M, Delahanty LM, Araneta MRG, Walford GA, Jacobs SBR, Ibebuogu UN, Franks PW, Knowler WC, Florez JC; Diabetes Prevention Program Research Group. Interaction Between Type 2 Diabetes Prevention Strategies and Genetic Determinants of Coronary Artery Disease on Cardiometabolic Risk Factors. Diabetes. 2020 Jan;69(1):112-120. doi: 10.2337/db19-0097. Epub 2019 Oct 21.

    PMID: 31636172DERIVED

  • 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.

    PMID: 31320445DERIVED

  • 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.

    PMID: 31296647DERIVED

  • 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.

    PMID: 31009939DERIVED

  • 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.

    PMID: 30877090DERIVED

  • 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.

    PMID: 30646133DERIVED

  • Hivert MF, Christophi CA, Jablonski KA, Edelstein SL, Kahn SE, Golden SH, Dagogo-Jack S, Mather KJ, Luchsinger JA, Caballero AE, Barrett-Connor E, Knowler WC, Florez JC, Herman WH. Genetic Ancestry Markers and Difference in A1c Between African American and White in the Diabetes Prevention Program. J Clin Endocrinol Metab. 2019 Feb 1;104(2):328-336. doi: 10.1210/jc.2018-01416.

    PMID: 30358859DERIVED

  • 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.

    PMID: 30275282DERIVED

  • Berger SE, Huggins GS, McCaffery JM, Lichtenstein AH. Comparison among criteria to define successful weight-loss maintainers and regainers in the Action for Health in Diabetes (Look AHEAD) and Diabetes Prevention Program trials. Am J Clin Nutr. 2017 Dec;106(6):1337-1346. doi: 10.3945/ajcn.117.157446. Epub 2017 Oct 18.

    PMID: 29046304DERIVED

  • Herman WH, Pan Q, Edelstein SL, Mather KJ, Perreault L, Barrett-Connor E, Dabelea DM, Horton E, Kahn SE, Knowler WC, Lorenzo C, Pi-Sunyer X, Venditti E, Ye W; Diabetes Prevention Program Research Group. Impact of Lifestyle and Metformin Interventions on the Risk of Progression to Diabetes and Regression to Normal Glucose Regulation in Overweight or Obese People With Impaired Glucose Regulation. Diabetes Care. 2017 Dec;40(12):1668-1677. doi: 10.2337/dc17-1116. Epub 2017 Oct 11.

    PMID: 29021207DERIVED

  • Sylvetsky AC, Edelstein SL, Walford G, Boyko EJ, Horton ES, Ibebuogu UN, Knowler WC, Montez MG, Temprosa M, Hoskin M, Rother KI, Delahanty LM; Diabetes Prevention Program Research Group. A High-Carbohydrate, High-Fiber, Low-Fat Diet Results in Weight Loss among Adults at High Risk of Type 2 Diabetes. J Nutr. 2017 Nov;147(11):2060-2066. doi: 10.3945/jn.117.252395. Epub 2017 Sep 27.

    PMID: 28954840DERIVED

  • 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.

    PMID: 28833481DERIVED

  • 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.

    PMID: 28770322DERIVED

  • 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.

    PMID: 28702228DERIVED

  • 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.

    PMID: 28500216DERIVED

  • Varga TV, Winters AH, Jablonski KA, Horton ES, Khare-Ranade P, Knowler WC, Marcovina SM, Renstrom F, Watson KE, Goldberg R, Florez JC, Pollin TI, Franks PW. Comprehensive Analysis of Established Dyslipidemia-Associated Loci in the Diabetes Prevention Program. Circ Cardiovasc Genet. 2016 Dec;9(6):495-503. doi: 10.1161/CIRCGENETICS.116.001457. Epub 2016 Oct 26.

    PMID: 27784733DERIVED

  • McCaffery JM, Jablonski KA, Franks PW, Delahanty LM, Aroda V, Marrero D, Hamman RF, Horton ES, Dagogo-Jack S, Wylie-Rosett J, Barrett-Connor E, Kitabchi A, Knowler WC, Wing RR, Florez JC; Diabetes Prevention Program Research Group. Replication of the Association of BDNF and MC4R Variants With Dietary Intake in the Diabetes Prevention Program. Psychosom Med. 2017 Feb/Mar;79(2):224-233. doi: 10.1097/PSY.0000000000000380.

    PMID: 27551991DERIVED

  • Kim C, Barrett-Connor E, Aroda VR, Mather KJ, Christophi CA, Horton ES, Pi-Sunyer X, Bray GA, Labrie F, Golden SH; Diabetes Prevention Program Research Group. Testosterone and depressive symptoms among men in the Diabetes Prevention Program. Psychoneuroendocrinology. 2016 Oct;72:63-71. doi: 10.1016/j.psyneuen.2016.06.009. Epub 2016 Jun 15.

    PMID: 27371769DERIVED

  • Walford GA, Ma Y, Clish C, Florez JC, Wang TJ, Gerszten RE; Diabetes Prevention Program Research Group. Metabolite Profiles of Diabetes Incidence and Intervention Response in the Diabetes Prevention Program. Diabetes. 2016 May;65(5):1424-33. doi: 10.2337/db15-1063. Epub 2016 Feb 9.

    PMID: 26861782DERIVED

  • Papandonatos GD, Pan Q, Pajewski NM, Delahanty LM, Peter I, Erar B, Ahmad S, Harden M, Chen L, Fontanillas P; GIANT Consortium; Wagenknecht LE, Kahn SE, Wing RR, Jablonski KA, Huggins GS, Knowler WC, Florez JC, McCaffery JM, Franks PW; Diabetes Prevention Program and the Look AHEAD Research Groups. Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials. Diabetes. 2015 Dec;64(12):4312-21. doi: 10.2337/db15-0441. Epub 2015 Aug 7.

    PMID: 26253612DERIVED

  • Mather KJ, Kim C, Christophi CA, Aroda VR, Knowler WC, Edelstein SE, Florez JC, Labrie F, Kahn SE, Goldberg RB, Barrett-Connor E; Diabetes Prevention Program. Steroid Sex Hormones, Sex Hormone-Binding Globulin, and Diabetes Incidence in the Diabetes Prevention Program. J Clin Endocrinol Metab. 2015 Oct;100(10):3778-86. doi: 10.1210/jc.2015-2328. Epub 2015 Jul 22.

    PMID: 26200237DERIVED

  • Rockette-Wagner B, Edelstein S, Venditti EM, Reddy D, Bray GA, Carrion-Petersen ML, Dabelea D, Delahanty LM, Florez H, Franks PW, Montez MG, Rubin R, Kriska AM; Diabetes Prevention Program Research Group. The impact of lifestyle intervention on sedentary time in individuals at high risk of diabetes. Diabetologia. 2015 Jun;58(6):1198-202. doi: 10.1007/s00125-015-3565-0. Epub 2015 Apr 8.

    PMID: 25851102DERIVED

  • 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.

    PMID: 25775165DERIVED

  • 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.

    PMID: 25706240DERIVED

  • 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.

    PMID: 25336746DERIVED

  • 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.

    PMID: 25277389DERIVED

  • Franks PW, Christophi CA, Jablonski KA, Billings LK, Delahanty LM, Horton ES, Knowler WC, Florez JC; Diabetes Prevention Program Research Group. Common variation at PPARGC1A/B and change in body composition and metabolic traits following preventive interventions: the Diabetes Prevention Program. Diabetologia. 2014 Mar;57(3):485-90. doi: 10.1007/s00125-013-3133-4. Epub 2013 Dec 7.

    PMID: 24317794DERIVED

  • Goldberg R, Temprosa M, Otvos J, Brunzell J, Marcovina S, Mather K, Arakaki R, Watson K, Horton E, Barrett-Connor E. Lifestyle and metformin treatment favorably influence lipoprotein subfraction distribution in the Diabetes Prevention Program. J Clin Endocrinol Metab. 2013 Oct;98(10):3989-98. doi: 10.1210/jc.2013-1452. Epub 2013 Aug 26.

    PMID: 23979954DERIVED

  • Maruthur NM, Ma Y, Delahanty LM, Nelson JA, Aroda V, White NH, Marrero D, Brancati FL, Clark JM; Diabetes Prevention Program Research Group. Early response to preventive strategies in the Diabetes Prevention Program. J Gen Intern Med. 2013 Dec;28(12):1629-36. doi: 10.1007/s11606-013-2548-4. Epub 2013 Jul 17.

    PMID: 23860722DERIVED

  • 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.

    PMID: 23709097DERIVED

  • Delahanty LM, Peyrot M, Shrader PJ, Williamson DA, Meigs JB, Nathan DM; DPP Research Group. Pretreatment, psychological, and behavioral predictors of weight outcomes among lifestyle intervention participants in the Diabetes Prevention Program (DPP). Diabetes Care. 2013 Jan;36(1):34-40. doi: 10.2337/dc12-0733. Epub 2012 Nov 5.

    PMID: 23129133DERIVED

  • 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.

    PMID: 23002085DERIVED

  • Florez JC, Jablonski KA, Taylor A, Mather K, Horton E, White NH, Barrett-Connor E, Knowler WC, Shuldiner AR, Pollin TI; Diabetes Prevention Program Research Group. The C allele of ATM rs11212617 does not associate with metformin response in the Diabetes Prevention Program. Diabetes Care. 2012 Sep;35(9):1864-7. doi: 10.2337/dc11-2301. Epub 2012 Jun 29.

    PMID: 22751958DERIVED

  • Florez H, Pan Q, Ackermann RT, Marrero DG, Barrett-Connor E, Delahanty L, Kriska A, Saudek CD, Goldberg RB, Rubin RR; Diabetes Prevention Program Research Group. Impact of lifestyle intervention and metformin on health-related quality of life: the diabetes prevention program randomized trial. J Gen Intern Med. 2012 Dec;27(12):1594-601. doi: 10.1007/s11606-012-2122-5. Epub 2012 Jun 13.

    PMID: 22692637DERIVED

  • 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.

    PMID: 22683134DERIVED

  • 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.

    PMID: 22443353DERIVED

  • 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.

    PMID: 22442396DERIVED

  • 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.

    PMID: 22442395DERIVED

  • Delahanty LM, Pan Q, Jablonski KA, Watson KE, McCaffery JM, Shuldiner A, Kahn SE, Knowler WC, Florez JC, Franks PW; Diabetes Prevention Program Research Group. Genetic predictors of weight loss and weight regain after intensive lifestyle modification, metformin treatment, or standard care in the Diabetes Prevention Program. Diabetes Care. 2012 Feb;35(2):363-6. doi: 10.2337/dc11-1328. Epub 2011 Dec 16.

    PMID: 22179955DERIVED

  • Florez H, Ma Y, Crandall JP, Perreault L, Marcovina SM, Bray GA, Saudek CD, Barrett-Connor E, Knowler WC; Diabetes Prevention Program Research Group. Parental longevity and diabetes risk in the Diabetes Prevention Program. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1211-7. doi: 10.1093/gerona/glr114. Epub 2011 Aug 17.

    PMID: 21852284DERIVED

  • Jablonski KA, McAteer JB, de Bakker PI, Franks PW, Pollin TI, Hanson RL, Saxena R, Fowler S, Shuldiner AR, Knowler WC, Altshuler D, Florez JC; Diabetes Prevention Program Research Group. Common variants in 40 genes assessed for diabetes incidence and response to metformin and lifestyle intervention in the diabetes prevention program. Diabetes. 2010 Oct;59(10):2672-81. doi: 10.2337/db10-0543. Epub 2010 Aug 3.

    PMID: 20682687DERIVED

  • Goldberg RB, Temprosa M, Haffner S, Orchard TJ, Ratner RE, Fowler SE, Mather K, Marcovina S, Saudek C, Matulik MJ, Price D; Diabetes Prevention Program Research Group. Effect of progression from impaired glucose tolerance to diabetes on cardiovascular risk factors and its amelioration by lifestyle and metformin intervention: the Diabetes Prevention Program randomized trial by the Diabetes Prevention Program Research Group. Diabetes Care. 2009 Apr;32(4):726-32. doi: 10.2337/dc08-0494. Epub 2009 Jan 26.

    PMID: 19171717DERIVED

  • Diabetes Prevention Program Research Group. Changes in albumin excretion in the diabetes prevention program. Diabetes Care. 2009 Apr;32(4):720-5. doi: 10.2337/dc08-1400. Epub 2009 Jan 8.

    PMID: 19131464DERIVED

  • Franks PW, Jablonski KA, Delahanty LM, McAteer JB, Kahn SE, Knowler WC, Florez JC; Diabetes Prevention Program Research Group. Assessing gene-treatment interactions at the FTO and INSIG2 loci on obesity-related traits in the Diabetes Prevention Program. Diabetologia. 2008 Dec;51(12):2214-23. doi: 10.1007/s00125-008-1158-x. Epub 2008 Oct 7.

    PMID: 18839134DERIVED

  • Moore AF, Jablonski KA, McAteer JB, Saxena R, Pollin TI, Franks PW, Hanson RL, Shuldiner AR, Knowler WC, Altshuler D, Florez JC; Diabetes Prevention Program Research Group. Extension of type 2 diabetes genome-wide association scan results in the diabetes prevention program. Diabetes. 2008 Sep;57(9):2503-10. doi: 10.2337/db08-0284. Epub 2008 Jun 10.

    PMID: 18544707DERIVED

  • Franks PW, Jablonski KA, Delahanty L, Hanson RL, Kahn SE, Altshuler D, Knowler WC, Florez JC; Diabetes Prevention Program Research Group. The Pro12Ala variant at the peroxisome proliferator-activated receptor gamma gene and change in obesity-related traits in the Diabetes Prevention Program. Diabetologia. 2007 Dec;50(12):2451-60. doi: 10.1007/s00125-007-0826-6. Epub 2007 Sep 27.

    PMID: 17898990DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose IntoleranceDiabetes MellitusMotor ActivityHypersensitivity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaBehaviorImmune System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Sarah Fowler, PhD

    George Washington University Biostatistics Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2000

First Posted

March 20, 2000

Study Start

July 1, 1996

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

US(1)