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Diabetes Prevention Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004992
First Posted: March 20, 2000
Last Update Posted: February 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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)
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
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 3819 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 IGT, impaired glucose tolerance. Each person in the study will be followed for 3 to 6 years.

Condition Intervention
Diabetes Mellitus, Non-Insulin-Dependent Glucose Intolerance Behavioral: Intensive lifestyle

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 3819
Study Start Date: July 1996
Estimated Study Completion Date: April 2001
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Impaired glucose tolerance (FPG 95-125 mg/dL and 2hr PG 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004992


Locations
United States, Maryland
George Washington University Biostatistics Center, Suite 750, 6110 Executive Blvd
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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)
Investigators
Principal Investigator: Sarah Fowler, PhD
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Varga TV, Winters AH, Jablonski KA, Horton ES, Khare-Ranade P, Knowler WC, Marcovina SM, Renström 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.
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.
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.
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. Erratum in: J Clin Endocrinol Metab. 2015 Dec;100(12):4686.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. Epub 2012 Jun 29.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. Epub 2007 Sep 27.

ClinicalTrials.gov Identifier: NCT00004992     History of Changes
Other Study ID Numbers: (IND) - DPP (completed)
DK48489
First Submitted: March 17, 2000
First Posted: March 20, 2000
Last Update Posted: February 7, 2011
Last Verified: February 2011

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
clinical trial
multi-center
NIDDM
NIDDK
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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia


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