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Diabetes Prevention Program

Primary Purpose

Diabetes Mellitus, Non-Insulin-Dependent, Glucose Intolerance

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intensive lifestyle
Metformin
Placebo
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Non-Insulin-Dependent focused on measuring clinical trial, multi-center, NIDDM, NIDDK, Diabetes Prevention Program (DPP), diabetes risk factors, diabetes, glycemia, cardiovascular risk factors, quality of life, physical activity and nutrition, occurrence of adverse events, insulin secretion and sensitivity, prevention, abnormal glucose metabolism, lifestyle intervention, drug intervention

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Metformin

Intensive Lifestyle

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 17, 2000
Last Updated
February 28, 2018
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Minority Health and Health Disparities (NIMHD), Office of Research on Women's Health (ORWH)
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1. Study Identification

Unique Protocol Identification Number
NCT00004992
Brief Title
Diabetes Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
April 2001 (Actual)
Study Completion Date
April 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Minority Health and Health Disparities (NIMHD), Office of Research on Women's Health (ORWH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent, Glucose Intolerance
Keywords
clinical trial, multi-center, NIDDM, NIDDK, Diabetes Prevention Program (DPP), diabetes risk factors, diabetes, glycemia, cardiovascular risk factors, quality of life, physical activity and nutrition, occurrence of adverse events, insulin secretion and sensitivity, prevention, abnormal glucose metabolism, lifestyle intervention, drug intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Metformin
Arm Type
Active Comparator
Arm Title
Intensive Lifestyle
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Intensive lifestyle
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Development of diabetes
Description
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
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Fowler, PhD
Organizational Affiliation
George Washington University Biostatistics Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States

12. IPD Sharing Statement

Citations:
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16855264
Citation
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.
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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.
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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.
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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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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.
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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. Erratum In: Ann Intern Med. 2020 Sep 15;173(6):508.
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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.
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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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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. Erratum In: Diabetes Care. 2013 Dec;36(12):4173-5.
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22179955
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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.
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PubMed Identifier
21852284
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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.
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PubMed Identifier
20682687
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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.
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19171717
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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.
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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.
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18839134
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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. Erratum In: Diabetologia. 2009 Jul;52(7):1456.
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18544707
Citation
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.
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PubMed Identifier
17898990
Citation
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.
Results Reference
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