Diabetes Prevention Program

NCT ID: NCT00004992

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-07-31
• Study Completion Date: 2001-04-30

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.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent; Glucose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Metformin

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Intensive Lifestyle

Group Type: ACTIVE_COMPARATOR

Intensive lifestyle

Intervention Type: BEHAVIORAL

Interventions

Intensive lifestyle

Intervention Type: BEHAVIORAL

Metformin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• Exclusions related to medications

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Office of Research on Women's Health (ORWH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Fowler, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University Biostatistics Center

Locations

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

Rockville, Maryland, United States

Countries

United States

References

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Other Identifiers

U01DK048489

Identifier Type: NIH

Identifier Source: secondary_id

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(IND) - DPP (completed)

Identifier Type: -

Identifier Source: org_study_id