The Diabetes Prevention Program A Randomized Clinical Trial to ...

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The Diabetes Prevention Program A Randomized Clinical Trial to ...

  1. 1. The Diabetes Prevention ProgramThe Diabetes Prevention Program A Randomized Clinical TrialA Randomized Clinical Trial to Prevent Type 2 Diabetesto Prevent Type 2 Diabetes in Persons at High Riskin Persons at High Risk The DPP Research GroupThe DPP Research Group
  2. 2. Institutions and InvestigatorsInstitutions and Investigators Abbas KitabchiAbbas KitabchiU. of TennesseeU. of Tennessee Steven KahnSteven KahnU. of WashingtonU. of Washington Edward HortonEdward HortonJoslin Diabetes CenterJoslin Diabetes Center Richard HammanRichard HammanU. of Colorado Health Sciences CenterU. of Colorado Health Sciences Center Steven HaffnerSteven HaffnerU. of Texas Health Science CenterU. of Texas Health Science Center Ronald GoldbergRonald GoldbergU. of Miami School of MedicineU. of Miami School of Medicine Pamela WatsonPamela WatsonThomas Jefferson U.Thomas Jefferson U. David EhrmannDavid EhrmannU. of Chicago HospitalsU. of Chicago Hospitals George BrayGeorge BrayPennington Biomedical Research CenterPennington Biomedical Research Center
  3. 3. Institutions and InvestigatorsInstitutions and Investigators Boyd MetzgerBoyd MetzgerNorthwestern U. Med. SchoolNorthwestern U. Med. School David NathanDavid NathanMassachusetts General HospitalMassachusetts General Hospital Jerrold OlefskyJerrold OlefskyU. of California, San DiegoU. of California, San Diego Xavier Pi-SunyerXavier Pi-SunyerSt. Luke’s-Roosevelt HospitalSt. Luke’s-Roosevelt Hospital David MarreroDavid MarreroIndiana U. School of MedicineIndiana U. School of Medicine David SchadeDavid SchadeU. of New Mexico School of MedicineU. of New Mexico School of Medicine Christopher SaudekChristopher SaudekJohns Hopkins UJohns Hopkins U Neil WhiteNeil WhiteWashington U. School of MedicineWashington U. School of Medicine Robert RatnerRobert RatnerMedstar Clinical Research CenterMedstar Clinical Research Center
  4. 4. Institutions and InvestigatorsInstitutions and Investigators Mohammed SaadMohammed SaadU. of California Los AngelesU. of California Los Angeles Sarah FowlerSarah FowlerGeorge Washington UniversityGeorge Washington University (Coordinating Center)(Coordinating Center) Harry ShamoonHarry ShamoonAlbert Einstein College of MedicineAlbert Einstein College of Medicine Rena WingRena WingU. of Pittsburgh Medical CenterU. of Pittsburgh Medical Center Richard ArakakiRichard ArakakiU. of HawaiiU. of Hawaii William KnowlerWilliam KnowlerSouthwest American Indian CenterSouthwest American Indian Center for Diabetes Preventionfor Diabetes Prevention
  5. 5. Central ResourcesCentral Resources Lifestyle coreLifestyle core Univ. PittsburghUniv. Pittsburgh Medication resource groupMedication resource group Albert EinsteinAlbert Einstein Central biochemistry labCentral biochemistry lab Univ. WashingtonUniv. Washington ECG reading centerECG reading center Wake Forest Univ.Wake Forest Univ. Carotid US reading centerCarotid US reading center New England Medical CenterNew England Medical Center CT scan reading centerCT scan reading center Univ. of Colorado HealthUniv. of Colorado Health Sciences CenterSciences Center Nutrition coding centerNutrition coding center Univ. South CarolinaUniv. South Carolina Quality of well being centerQuality of well being center Univ. California San DiegoUniv. California San Diego Drug distribution centerDrug distribution center McKesson BiosciencesMcKesson Biosciences Community outreach/mediaCommunity outreach/media Matthews Media GroupMatthews Media Group Clinical monitoring groupClinical monitoring group ACRNACRN
  6. 6. SponsorsSponsors • National Institute of Diabetes & Digestive & Kidney DiseasesNational Institute of Diabetes & Digestive & Kidney Diseases • Other NIH Institutes, OfficesOther NIH Institutes, Offices National Center on Minority Health and Health DisparitiesNational Center on Minority Health and Health Disparities National Institute of Child Health and Human DevelopmentNational Institute of Child Health and Human Development National Institute on AgingNational Institute on Aging National Center for Research Resources, GCRC ProgramNational Center for Research Resources, GCRC Program Office of Research on Women’s HealthOffice of Research on Women’s Health • Other Federal AgenciesOther Federal Agencies Indian Health ServiceIndian Health Service Centers for Disease Control and PreventionCenters for Disease Control and Prevention • American Diabetes AssociationAmerican Diabetes Association
  7. 7. SponsorsSponsors • Industrial grant supportIndustrial grant support Bristol-Myers SquibbBristol-Myers Squibb Warner-LambertWarner-Lambert.. • Additional SupportAdditional Support LifeScan, IncLifeScan, Inc Merck & Co.Merck & Co. Health O MeterHealth O Meter Nike Sports MarketingNike Sports Marketing Hoechst Marion Roussel, Inc.Hoechst Marion Roussel, Inc. Slim Fast Foods Co.Slim Fast Foods Co. Merck-Medco ManagedMerck-Medco Managed Quaker Oats Co.Quaker Oats Co. Care, IncCare, Inc
  8. 8. • There is a long period of glucose intolerance thatThere is a long period of glucose intolerance that precedes the development of diabetesprecedes the development of diabetes • Screening tests can identify persons at high riskScreening tests can identify persons at high risk • There are safe, potentially effectiveThere are safe, potentially effective interventions that can address modifiable riskinterventions that can address modifiable risk factorsfactors Feasibility of PreventingFeasibility of Preventing Type 2 DiabetesType 2 Diabetes
  9. 9. Modifiable Risk Factors forModifiable Risk Factors for Type 2 DiabetesType 2 Diabetes • ObesityObesity • Body fat distributionBody fat distribution • Physical inactivityPhysical inactivity • ElevatedElevated fasting and 2 hr glucose levelsfasting and 2 hr glucose levels
  10. 10. • To prevent or delay the developmentTo prevent or delay the development of type 2 diabetes in persons withof type 2 diabetes in persons with impaired glucose tolerance (IGT)impaired glucose tolerance (IGT) DPP Primary GoalDPP Primary Goal
  11. 11. DPP Secondary GoalsDPP Secondary Goals • Reduce cardiovascular diseaseReduce cardiovascular disease (CVD) events(CVD) events • Reduce CVD risk factorsReduce CVD risk factors • Reduce atherosclerosisReduce atherosclerosis
  12. 12. Study DesignStudy Design • 3-group randomized clinical trial3-group randomized clinical trial • 27 clinical sites27 clinical sites • Standardized across clinics:Standardized across clinics: –Common protocol and procedures manualCommon protocol and procedures manual –Staff trainingStaff training –Data quality control programData quality control program
  13. 13. Diabetes Prevention Program ClinicsDiabetes Prevention Program Clinics . . . .. . . . . . . . . .. . .. .. .. .. ..
  14. 14. • AgeAge >> 25 years25 years • Plasma glucosePlasma glucose – 2 hour glucose 140-199 mg/dl (7.8- <11.1 mmol/L)2 hour glucose 140-199 mg/dl (7.8- <11.1 mmol/L) andand – Fasting glucose 95-125 mg/dl (5.3- <7.0 mmol/L)Fasting glucose 95-125 mg/dl (5.3- <7.0 mmol/L) • Body mass indexBody mass index >> 24 kg/m24 kg/m22 • All ethnic groupsAll ethnic groups goal of up to 50% from high risk populationsgoal of up to 50% from high risk populations Eligibility CriteriaEligibility Criteria
  15. 15. Screening and RecruitmentScreening and Recruitment Step 1Step 1 screeningscreening Step 2Step 2 OGTTOGTT Step 3Step 3 start run-instart run-in Step 4Step 4 randomizationrandomization Number of participantsNumber of participants 158,177158,177 30,98530,985 4,7194,719 4,0804,080 3,819*3,819* Step 3Step 3 end run-inend run-in **3,234 in 3 arm study3,234 in 3 arm study (585 in troglitazone arm)(585 in troglitazone arm) The DPP Research Group, Controlled Clin Trials (in press)
  16. 16. Study InterventionsStudy Interventions Eligible participantsEligible participants RandomizedRandomized Standard lifestyle recommendationsStandard lifestyle recommendations Intensive Metformin PlaceboIntensive Metformin Placebo LifestyleLifestyle (n = 1079) (n = 1073) (n = 1082)(n = 1079) (n = 1073) (n = 1082)
  17. 17. Primary Outcome: DiabetesPrimary Outcome: Diabetes • Annual fasting plasma glucose (FPG)Annual fasting plasma glucose (FPG) and 75 gm Oral Glucose Tolerance Testand 75 gm Oral Glucose Tolerance Test – FPGFPG >> 126 mg/dL (7.0 mmol/L) or126 mg/dL (7.0 mmol/L) or – 2-hr2-hr >> 200 mg/dL (11.0 mmol/L),200 mg/dL (11.0 mmol/L), – Either confirmed with repeat testEither confirmed with repeat test • Semi-annual FPGSemi-annual FPG – >> 126 mg/dL, confirmed126 mg/dL, confirmed
  18. 18. Lifestyle InterventionLifestyle Intervention An intensive program with theAn intensive program with the following specific goals:following specific goals: • >> 7% loss of body weight and maintenance of7% loss of body weight and maintenance of weight lossweight loss – Dietary fat goal -- <25% of calories from fatDietary fat goal -- <25% of calories from fat – Calorie intake goal -- 1200-1800 kcal/dayCalorie intake goal -- 1200-1800 kcal/day • >> 150 minutes per week of physical activity150 minutes per week of physical activity
  19. 19. Lifestyle Intervention StructureLifestyle Intervention Structure • 16 session core curriculum (over 24 weeks)16 session core curriculum (over 24 weeks) • Long-term maintenance programLong-term maintenance program • Supervised by a case managerSupervised by a case manager • Access to lifestyle support staffAccess to lifestyle support staff – DietitianDietitian – Behavior counselorBehavior counselor – Exercise specialistExercise specialist
  20. 20. The Core CurriculumThe Core Curriculum • 16 session course conducted over 24 weeks16 session course conducted over 24 weeks • Education and training in diet and exerciseEducation and training in diet and exercise methods and behavior modification skillsmethods and behavior modification skills • Emphasis on:Emphasis on: – Self monitoring techniquesSelf monitoring techniques – Problem solvingProblem solving – Individualizing programsIndividualizing programs – Self esteem, empowerment, and socialSelf esteem, empowerment, and social supportsupport – Frequent contact with case manager and DPPFrequent contact with case manager and DPP support staffsupport staff
  21. 21. Post Core ProgramPost Core Program • Self-monitoring and other behavioral strategiesSelf-monitoring and other behavioral strategies • Monthly visitsMonthly visits – Must be seen in person at least every two monthsMust be seen in person at least every two months • Supervised exercise sessions offeredSupervised exercise sessions offered • Periodic group classes and motivationalPeriodic group classes and motivational campaignscampaigns • Tool box strategiesTool box strategies – Provide exercise videotapes, pedometersProvide exercise videotapes, pedometers – Enroll in health club or cooking classEnroll in health club or cooking class
  22. 22. DPP Study Interventions:DPP Study Interventions: Criteria for Drug TreatmentCriteria for Drug Treatment • EfficacyEfficacy • SafetySafety • Tolerability - minimal side effectsTolerability - minimal side effects • Acceptability - dose frequencyAcceptability - dose frequency
  23. 23. Metformin- 850 mg per day escalating afterMetformin- 850 mg per day escalating after 4 weeks to 850 mg twice per day4 weeks to 850 mg twice per day parallel with active drugsparallel with active drugs Interventions:Interventions: MedicationsMedications
  24. 24. DPP PopulationDPP Population CaucasianCaucasian 1768 (55%)1768 (55%) AfricanAfrican AmericanAmerican 645 (20%)645 (20%) HispanicHispanic AmericanAmerican 508 (16%)508 (16%) Asian/Pacific IslanderAsian/Pacific Islander 142 (4%)142 (4%) American IndianAmerican Indian 171 (5%)171 (5%) The DPP Research Group, Diabetes Care 23:1619-29, 2000
  25. 25. DPP PopulationDPP Population Sex DistributionSex Distribution Age DistributionAge Distribution 25-44 31% > 60 20% 45-59 49% Men 32% Women 68% The DPP Research Group, Diabetes Care 23:1619-29, 2000
  26. 26. Retention and ParticipationRetention and Participation • 99.6% of the study cohort alive at study end99.6% of the study cohort alive at study end • 93% completed study93% completed study • 93% of annual visits completed93% of annual visits completed • Average follow-up 2.8 years (range 1.8 - 4.6)Average follow-up 2.8 years (range 1.8 - 4.6) The DPP Research Group, NEJM 346:393-403, 2002
  27. 27. Lifestyle Intervention:Lifestyle Intervention: Physical Activity ResultsPhysical Activity Results • 74% of volunteers assigned to74% of volunteers assigned to intensive lifestyle achieved theintensive lifestyle achieved the study goal ofstudy goal of >> 150 minutes of150 minutes of activity per week at 24 weeksactivity per week at 24 weeks The DPP Research Group, NEJM 346:393-403, 2002
  28. 28. Mean Change in Leisure Physical ActivityMean Change in Leisure Physical Activity 0 2 4 6 8 0 1 2 3 4 Years from Randomization MET-hours/week Placebo Metformin Lifestyle The DPP Research Group, NEJM 346:393-403, 2002
  29. 29. -8 -6 -4 -2 0 0 1 2 3 4 Years from Randomization WeightChange(kg) Placebo Metformin Lifestyle Mean Weight ChangeMean Weight Change The DPP Research Group, NEJM 346:393-403, 2002
  30. 30. Percent TakingPercent Taking >> 80% of Prescribed80% of Prescribed Dose of Coded MedicationDose of Coded Medication 0 20 40 60 80 100 1 2 3 4 Years from Randomization %ofParticipants Metformin Placebo The DPP Research Group, NEJM 346:393-403, 2002
  31. 31. 0 1 2 3 4 0 10 20 30 40 Placebo (n=1082) Metformin (n=1073, p<0.001 vs. Plac) Lifestyle (n=1079, p<0.001 vs. Met , p<0.001 vs. Plac ) Percent developing diabetes All participantsAll participants Years from randomization Cumulativeincidence(%) Placebo (n=1082) Metformin (n=1073, p<0.001 vs. Placebo) Lifestyle (n=1079, p<0.001 vs. Metformin , p<0.001 vs. Placebo) Incidence of DiabetesIncidence of Diabetes Risk reductionRisk reduction 31% by metformin31% by metformin 58% by lifestyle58% by lifestyle The DPP Research Group, NEJM 346:393-403, 2002
  32. 32. Effect of Treatment on Incidence of DiabetesEffect of Treatment on Incidence of Diabetes PlaceboPlacebo MetforminMetformin LifestyleLifestyle IncidenceIncidence of diabetes 11.0% 7.8%of diabetes 11.0% 7.8% 4.8%4.8% (percent per year)(percent per year) ReductionReduction in incidencein incidence -------- 31% 58%31% 58% compared with placebocompared with placebo Number needed to treatNumber needed to treat -------- 13.913.9 6.96.9 to prevent 1 case in 3 yearsto prevent 1 case in 3 years The DPP Research Group, NEJM 346:393-403, 2002
  33. 33. Mean Change in Fasting Plasma GlucoseMean Change in Fasting Plasma Glucose 100 105 110 115 0 1 2 3 4 Years from Randomization FPG(mg/dl) Placebo Metformin Lifestyle The DPP Research Group, NEJM 346:393-403, 2002
  34. 34. Mean Change in HbAMean Change in HbA1c1c 5.8 5.9 6.0 6.1 0 1 2 3 4 Years from Randomization HbA1c(%) Placebo Metformin Lifestyle The DPP Research Group, NEJM 346:393-403, 2002
  35. 35. 0 4 8 12 Male (n=1043) Female (n=2191) Cases/100person-yr Lifestyle Metformin Placebo Diabetes Incidence Rates by SexDiabetes Incidence Rates by Sex The DPP Research Group, NEJM 346:393-403, 2002
  36. 36. 0 4 8 12 25-44 (n=1000) 45-59 (n=1586) > 60 (n=648) Cases/100person-yr Lifestyle Metformin Placebo Diabetes Incidence Rates by AgeDiabetes Incidence Rates by Age Age (years) The DPP Research Group, NEJM 346:393-403, 2002
  37. 37. Diabetes Incidence Rates by EthnicityDiabetes Incidence Rates by Ethnicity 0 4 8 12 Caucasian (n=1768) African American (n=645) Hispanic (n=508) American Indian (n=171) Asian (n=142) Cases/100person-yr Lifestyle Metformin Placebo The DPP Research Group, NEJM 346:393-403, 2002
  38. 38. 0 4 8 12 16 24 - < 30 30 - < 35 > 35 Cases/100person-yr Lifestyle Metformin Placebo (n=1045) (n=995) (n=1194) Diabetes Incidence Rates by BMIDiabetes Incidence Rates by BMI Body Mass Index (kg/m2 ) The DPP Research Group, NEJM 346:393-403, 2002
  39. 39. 0 5 10 15 20 95-109 (5.3- 6.0) (n=2174) 110-125 (6.1-6.9) (n=1060) Cases/100person-yr Lifestyle Metformin Placebo Diabetes Incidence Rates by Fasting GlucoseDiabetes Incidence Rates by Fasting Glucose Fasting Plasma Glucose: mg/dl (mmol/l) The DPP Research Group, NEJM 346:393-403, 2002
  40. 40. 0 4 8 12 16 140-153 (n=1049) 154-172 (n=1103) 173-199 (n=1082) Cases/100person-yr Lifestyle Metformin Placebo Diabetes Incidence Rates by 2-hr GlucoseDiabetes Incidence Rates by 2-hr Glucose 2-Hour Plasma Glucose (mg/dl) The DPP Research Group, NEJM 346:393-403, 2002
  41. 41. Consistency of Treatment EffectsConsistency of Treatment Effects • Lifestyle intervention was beneficialLifestyle intervention was beneficial regardless of ethnicity, age, BMI, or sexregardless of ethnicity, age, BMI, or sex • The efficacy of lifestyle relative to metforminThe efficacy of lifestyle relative to metformin was greater in older persons and in those withwas greater in older persons and in those with lower BMIlower BMI • The efficacy of metformin relative to placeboThe efficacy of metformin relative to placebo was greater in those with higher baselinewas greater in those with higher baseline fasting glucose and BMIfasting glucose and BMI
  42. 42. 0 20 40 60 80 1 2 3 4 Years from Randomization % Lifestyle Metformin Placebo Normal Fasting Glucose at Annual VisitsNormal Fasting Glucose at Annual Visits The DPP Research Group, NEJM 346:393-403, 2002
  43. 43. 0 20 40 60 1 2 3 4 Years from Randomization % Lifestyle Metformin Placebo Normal 2-hr Glucose at Annual VisitsNormal 2-hr Glucose at Annual Visits The DPP Research Group, NEJM 346:393-403, 2002
  44. 44. 0 10 20 30 40 50 1 2 3 4 Years from Randomization % Lifestyle Metformin Placebo Normal Fasting & 2-hr Glucose at Annual VisitsNormal Fasting & 2-hr Glucose at Annual Visits The DPP Research Group, NEJM 346:393-403, 2002
  45. 45. 0 10 20 30 40 50 1 2 3 4 % 0 20 40 60 80 1 2 3 4 % Normal Glucose at Annual VisitsNormal Glucose at Annual Visits Years from RandomizationYears from Randomization 0 20 40 60 1 2 3 4 % Years from RandomizationYears from Randomization Years from RandomizationYears from Randomization Normal Fasting GlucoseNormal Fasting Glucose Normal Fasting & 2-hr GlucoseNormal Fasting & 2-hr Glucose Normal 2-hr GlucoseNormal 2-hr Glucose LifestyleLifestyle MetforminMetformin PlaceboPlacebo The DPP Research Group, NEJM 346:393-403, 2002
  46. 46. Adverse EventsAdverse Events (rates per 100 person years)(rates per 100 person years) DeathDeath 0.160.16 0.200.20 0.100.10 HospitalizationHospitalization 7.97.9 8.48.4 8.08.0 GI SymptomsGI Symptoms 30.730.7 77.877.8 12.912.9 MusculoskeletalMusculoskeletal 21.121.1 20.020.0 24.124.1 SymptomsSymptoms ** significantly different from placebosignificantly different from placebo PlaceboPlacebo MetforminMetformin LifestyleLifestyle * * * The DPP Research Group, NEJM 346:393-403, 2002
  47. 47. Summary-1Summary-1 • Both interventions were well acceptedBoth interventions were well accepted and safeand safe • Intensive lifestyle resulted in weightIntensive lifestyle resulted in weight loss and increased activity level for theloss and increased activity level for the duration of the studyduration of the study
  48. 48. Summary-2Summary-2 • Both interventions were effective inBoth interventions were effective in men and women and all ethnic groupsmen and women and all ethnic groups • Intensive lifestyle intervention wasIntensive lifestyle intervention was effective in all age groups, includingeffective in all age groups, including thosethose >> 60 years of age60 years of age
  49. 49. Summary-3Summary-3 • Intensive lifestyle intervention reducedIntensive lifestyle intervention reduced the development of diabetes by 58%the development of diabetes by 58% • Metformin reduced the development ofMetformin reduced the development of diabetes by 31%diabetes by 31% • Lifestyle was more effective thanLifestyle was more effective than metforminmetformin
  50. 50. THANK YOU
  51. 51. Diabetes Prevention Program Baseline Characteristics
  52. 52. Participant Characteristics byParticipant Characteristics by Treatment Group Assignment (1)Treatment Group Assignment (1) Overall ILS Metformin Placebo n 3,234 1,079 1,073 1,082 Age (years)* 50.6 ± 10.7 50.6 ± 11.3 50.9 ± 10.3 50.3 ± 10.4 Sex** Male 1043 (32%) 345 (32%) 363 (34%) 335 (31%) Female 2191 (68%) 734 (68%) 710 (66%) 747 (69%) Ethnicity Caucasian 1768 (55%) 580 (54%) 602 (56%) 586 (54%) African-American 645 (20%) 204 (19%) 221 (21%) 220 (20%) Hispanic 508 (16%) 178 (17%) 162 (15%) 168 (16%) American Indian 171 (5%) 60 (6%) 52 (5%) 59 (6%) Asian-American 142 (4%) 57 (5%) 36 (3%) 49 (4%) *Mean ± SD; ** n, (%)The DPP Research Group, Diabetes Care 23:1619-29, 2000
  53. 53. Participant Characteristics byParticipant Characteristics by Treatment Group Assignment (2)Treatment Group Assignment (2) *Mean ± SD n FPG (mmol/L) * 5.9 ± 0.5 5.9 ± 0.4 5.9 ± 0.5 5.9 ± 0.5 BMI (kg/m2 ) 34.0 ± 6.7 33.9 ± 6.8 33.9 ± 6.6 34.2 ± 6.8 BP (mm Hg) Systolic 124 ± 15 124 ± 15 124 ± 15 124 ± 14 Diastolic 78 ± 9 79 ± 9 78 ± 10 78 ± 9 3,234 1,079 1,073 1,082 Overall ILS Metformin Placebo The DPP Research Group, Diabetes Care 23:1619-29, 2000
  54. 54. Demographic and SocioeconomicDemographic and Socioeconomic Characteristics by Sex (1)Characteristics by Sex (1) * n, (%) n Age (years) * 25 to <40 505 (16%) 113 (11%) 392 (18%) 40 to <50 1137 (35%) 286 (27%) 851 (39%) 50 to <60 945 (29%) 325 (31%) 620 (28%) ≥60 647 (20%) 319 (31%) 328 (15%) Race/Ethnicity Caucasian 1768 (55%) 608 (58%) 1160 (53%) African-American 645 (20%) 165 (16%) 480 (22%) Hispanic 508 (16%) 167 (16%) 341 (16%) American Indian 171 (5%) 20 (2%) 151 (7%) Asian American 142 (4%) 83 (8%) 59 (3%) Female 2,191 Overall 3,234 Male 1,043 The DPP Research Group, Diabetes Care 23:1619-29, 2000
  55. 55. Demographic and SocioeconomicDemographic and Socioeconomic Characteristics by Sex (2)Characteristics by Sex (2) * n, (%) n Employment Status * Employed 2401 (74.2%) 771 (73.9%) 1630 (74.4%) Retired 420 (13.0%) 217 (20.8%) 203 (9.3%) Homemaker 204 (6.3%) 1 (0.1%) 203 (9.3%) Not employed 121 (3.7%) 33 (3.2%) 88 (4.0%) Seasonally employed 25 (0.8%) 8 (0.8%) 17 (0.8%) Student 21 (0.6%) 2 (0.2%) 19 (0.9%) Other 37 (1.1%) 11 (1.1%) 26 (1.2%) Never worked 5 (0.2%) 0 (0.0%) 5 (0.2%) Male 1,043 Female 2,191 Overall 3,234 The DPP Research Group, Diabetes Care 23:1619-29, 2000
  56. 56. Demographic and SocioeconomicDemographic and Socioeconomic Characteristics by Sex (3)Characteristics by Sex (3) * n, (%) n Education in years * <13 834 (26%) 221 (21%) 613 (28%) 13 to 16 1556 (48%) 488 (47%) 1068 (49%) 17 or more 844 (26%) 334 (32%) 510 (23%) Annual family income < $20,000 446 (14%) 110 (11%) 336 (15%) $20,000 to <$35,000 561 (17%) 146 (14%) 415 (19%) $35,000 to <$50,000 641 (20%) 207 (20%) 434 (20%) $50,000 to <$75,000 646 (20%) 218 (21%) 428 (20%) > $75,000 682 (21%) 281 (27%) 401 (18%) Refused 257 (8%) 81 (8%) 176 (8%) Female 2,191 Overall 3,234 Male 1,043 The DPP Research Group, Diabetes Care 23:1619-29, 2000
  57. 57. Demographic and SocioeconomicDemographic and Socioeconomic Characteristics by Sex (4)Characteristics by Sex (4) * n, (%) n Marital status * Married 1999 (62%) 765 (73%) 1234 (56%) Divorced 448 (14%) 75 (7%) 373 (17%) Never married 420 (13%) 115 (11%) 305 (14%) Widowed 151 (5%) 31 (3%) 120 (6%) Living together 125 (4%) 31 (3%) 94 (4%) Separated 91 (3%) 26 (3%) 65 (3%) Smoking Never 1897 (59%) 497 (48%) 1400 (64%) Former 1111 (34%) 471 (45%) 640 (29%) Current 226 (7%) 75 (7%) 151 (7%) Female 2,191 Overall 3,234 Male 1,043 The DPP Research Group, Diabetes Care 23:1619-29, 2000
  58. 58. Self-reported Characteristics by Sex and EthnicitySelf-reported Characteristics by Sex and Ethnicity * n, (%) No. of MEN Fam hx type 2 diabetes * 690 (66%) 390 (64%) 117 (71%) 112 (67%) 13 (65%) 58 (70%) Hx of high cholesterol 389 (37%) 234 (39%) 65 (39%) 53 (32%) 3 (15%) 34 (41%) Hx of hypertension 302 (29%) 171 (28%) 58 (35%) 49 (29%) 5 (25%) 19 (23%) No. of WOMEN Fam hx type 2 diabetes 1553 (71%) 799 (69%) 360 (75%) 243 (71%) 116 (77%) 35 (60%) Hx of gest. diabetes 353 (16%) 191 (17%) 63 (13%) 55 (16%) 36 (24%) 8 (14%) Hx of high cholesterol 730 (33%) 429 (37%) 147 (31%) 114 (33%) 22 (15%) 17 (29%) Hx of hypertension 569 (26%) 303 (26%) 144 (30%) 68 (20%) 40 (27%) 15 (26%) African American 165 Overall 1,043 Caucasian 608 Hispanic American Indian 2,191 1,160 480 341 Asian American 167 20 83 151 59 The DPP Research Group, Diabetes Care 23:1619-29, 2000
  59. 59. Body Mass Index by Sex and EthnicityBody Mass Index by Sex and Ethnicity *Mean ± SD; **n, (%) No. of MEN BMI (kg/m2 ) * 32.0 ± 5.7 32.5 ± 5.8 32.5 ± 6.0 31.7 ± 5.0 31.2 ± 4.1 28.3 ± 3.7 range 22.7 - 70.9 24.0 - 70.9 24.4 - 64.9 24.4 - 54.4 24.3 - 40.1 22.7 - 44.0 <30 ** 453 (43%) 246 (41%) 66 (40%) 72 (43%) 8 (40%) 61 (74%) 30 to <40 505 (48%) 305 (50%) 84 (51%) 84 (50%) 11 (55%) 21 (25%) ≥40 85 (8%) 57 (9%) 15 (9%) 11 (7%) 1 (5%) 1 (1%) No. of WOMEN BMI (kg/m2 ) 34.9 ± 7.0 35.0 ± 7.1 36.3 ± 7.1 34.0 ± 6.0 33.9 ± 6.3 30.7 ± 6.5 range 22.1 - 71.5 23.9 - 71.5 24.1 - 65.1 22.6 - 64.9 24.0 - 55.4 22.1 - 50.4 <30 593 (27%) 325 (28%) 101 (21%) 94 (28%) 38 (25%) 35 (59%) 30 to <40 1134 (52%) 585 (50%) 248 (52%) 194 (57%) 90 (60%) 16 (29%) ≥40 464 (21%) 250 (22%) 131 (27%) 53 (16%) 23 (15%) 7 (12%) 151 59 Asian American 167 20 83 Hispanic American Indian 2,191 1,160 480 341 African American 165 Overall 1,043 Caucasian 608 The DPP Research Group, Diabetes Care 23:1619-29, 2000
  60. 60. Glycemia by Sex and EthnicityGlycemia by Sex and Ethnicity *Mean ± SD; **n, (%) No. of MEN FPG (mmol/L) * 6.0 ± 0.5 6.0 ± 0.5 6.0 ± 0.4 6.0 ± 0.5 5.8 ± 0.4 6.0 ± 0.4 range 5.2 - 7.7 5.3 - 7.7 5.3 - 7.3 5.3 - 7.7 5.2 - 6.6 5.3 - 7.5 2-hr PG (mmol/L) 9.1 ± 0.9 9.2 ± 0.9 9.1 ± 1.0 9.1 ± 1.0 9.1 ± 0.9 9.1 ± 0.9 range 7.8 - 11.0 7.8 - 11.0 7.8 - 11.0 7.8 - 11.0 7.9 - 10.5 7.8 - 11.0 HbA1c (%) 5.9 ± 0.5 5.8 ± 0.4 6.2 ± 0.7 5.9 ± 0.5 5.8 ± 0.5 6.0 ± 0.4 range 4.0 - 7.7 4.0 - 7.2 4.2 - 7.7 4.4 - 7.2 4.5 - 6.7 4.8 - 6.8 > 6.1% ** 316 (30%) 133 (22%) 105 (64%) 47 (28%) 5 (25%) 26 (31%) No. of WOMEN FPG (mmol/L) 5.9 ± 0.4 5.9 ± 0.4 6.0 ± 0.5 5.8 ± 0.4 5.5 ± 0.5 5.9 ± 0.4 range 4.2 - 7.7 5.3 - 7.7 5.3 - 7.5 5.3 - 7.3 4.2 - 6.8 5.3 - 6.8 2-hr PG (mmol/L) 9.1 ± 0.9 9.2 ± 0.9 9.1 ± 1.0 9.1 ± 0.9 9.1 ± 1.0 9.4 ± 0.9 range 7.8 - 11.0 7.8 - 11.0 7.8 - 11.0 7.8 - 11.0 7.8 - 11.0 7.8 - 11.0 HbA1c (%) 5.9 ± 0.5 5.8 ± 0.4 6.2 ± 0.6 5.9 ± 0.5 6 ± 0.4 5.9 ± 0.4 range 3.2 - 8.5 3.6 - 7.4 3.2 - 8.5 4.4 - 7.5 5.0 - 7.6 4.5 - 7.1 > 6.1% 616 (28%) 215 (19%) 259 (54%) 76 (22%) 52 (34%) 15 (25%) African American 165 Overall 1,043 Caucasian 608 Hispanic American Indian 2,191 1,160 480 341 Asian American 167 20 83 151 59 The DPP Research Group, Diabetes Care 23:1619-29, 2000
  61. 61. Insulinemia by Sex and EthnicityInsulinemia by Sex and Ethnicity *Mean ± SD INSULIN (pmol/L) No. of MEN Fasting * 158 ± 99 157 ± 101 148 ± 74 178 ± 118 151 ± 70 155 ± 88 range 26 - 1104 27 - 684 26 - 510 43 - 1104 48 - 288 36 - 480 30-min 590 ± 423 555 ± 424 527 ± 317 711 ± 414 820 ± 760 661 ± 441 range 27 - 4854 31 - 4854 66 - 1812 27 - 2190 294 - 3480 78 - 2280 No. of WOMEN Fasting 158 ± 86 151 ± 80 167 ± 91 168 ± 91 170 ± 89 148 ± 103 range 14 - 720 14 - 552 18 - 576 32 - 720 34 - 534 36 - 576 30-min 607 ± 368 557 ± 323 617 ± 416 681 ± 378 810 ± 444 569 ± 276 range 18 - 3600 36 - 3600 18 - 3024 52 - 2100 78 - 2436 132 - 1248 Asian American 151 59 8320 Hispanic American Indian 2,191 1,160 480 341 African American 165 Overall 1,043 Caucasian 608 167 The DPP Research Group, Diabetes Care 23:1619-29, 2000
  62. 62. Lipids by Sex and EthnicityLipids by Sex and Ethnicity *Mean ± SD Lipids (mmol/L) No. of MEN Total cholesterol * 5.2 ± 0.9 5.2 ± 0.9 5.2 ± 0.9 5.2 ± 0.9 4.9 ± 1.0 5.4 ± 1.0 HDL cholesterol 1.0 ± 0.2 1.0 ± 0.2 1.1 ± 0.2 1.0 ± 0.2 1.0 ± 0.1 1.1 ± 0.2 LDL cholesterol 3.3 ± 0.8 3.2 ± 0.8 3.4 ± 0.9 3.2 ± 0.9 2.9 ± 1.0 3.4 ± 0.8 Trigylcerides 2.0 ± 1.1 2.1 ± 1.1 1.5 ± 0.9 2.2 ± 1.2 2.1 ± 1.1 2.0 ± 1.1 No. of WOMEN Total cholesterol 5.3 ± 1.0 5.4 ± 0.9 5.2 ± 1.0 5.2 ± 0.9 4.8 ± 1.0 5.4 ± 0.9 HDL cholesterol 1.2 ± 0.3 1.2 ± 0.3 1.3 ± 0.3 1.2 ± 0.3 1.2 ± 0.3 1.3 ± 0.3 LDL cholesterol 3.2 ± 0.9 3.2 ± 0.8 3.3 ± 0.9 3.2 ± 0.9 2.8 ± 0.8 3.2 ± 0.9 Trigylcerides 1.7 ± 0.9 1.9 ± 1.0 1.2 ± 0.6 1.8 ± 0.9 1.7 ± 0.8 2.0 ± 1.2 Asian American 151 59 8320 Hispanic American Indian 2,191 1,160 480 341 African American 165 Overall 1,043 Caucasian 608 167 The DPP Research Group, Diabetes Care 23:1619-29, 2000

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