the diabetes prevention program a randomized clinical trial to

The Diabetes Prevention ProgramThe Diabetes Prevention Program

A Randomized Clinical TrialA Randomized Clinical Trial to Prevent Type 2 Diabetes to Prevent Type 2 Diabetes

in Persons at High Risk in Persons at High Risk

The DPP Research GroupThe DPP Research Group

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


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


Mohammed SaadMohammed SaadU. of California Los AngelesU. of California Los Angeles

Sarah FowlerSarah FowlerGeorge Washington University George 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 Center Southwest American Indian Center for Diabetes Preventionfor Diabetes Prevention

Central ResourcesCentral ResourcesLifestyle coreLifestyle core Univ. PittsburghUniv. Pittsburgh

Medication resource groupMedication resource group Albert Einstein Albert 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 Health Univ. 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 Diego Univ. California San Diego

Drug distribution centerDrug distribution center McKesson BiosciencesMcKesson Biosciences

Community outreach/media Community outreach/media Matthews Media GroupMatthews Media Group

Clinical monitoring groupClinical monitoring group ACRNACRN

SponsorsSponsors

• National Institute of Diabetes & Digestive & Kidney Diseases National Institute of Diabetes & Digestive & Kidney Diseases

• Other NIH Institutes, OfficesOther NIH Institutes, OfficesNational Center on Minority Health and Health DisparitiesNational Center on Minority Health and Health DisparitiesNational Institute of Child Health and Human DevelopmentNational Institute of Child Health and Human DevelopmentNational Institute on AgingNational Institute on AgingNational Center for Research Resources, GCRC ProgramNational Center for Research Resources, GCRC ProgramOffice of Research on Women’s HealthOffice of Research on Women’s Health

• Other Federal AgenciesOther Federal Agencies Indian Health Service Indian Health Service Centers for Disease Control and PreventionCenters for Disease Control and Prevention

• American Diabetes Association American Diabetes Association

SponsorsSponsors

• Industrial grant supportIndustrial grant supportBristol-Myers SquibbBristol-Myers SquibbWarner-LambertWarner-Lambert..

• Additional SupportAdditional Support LifeScan, IncLifeScan, Inc Merck & Co.Merck & Co. Health O MeterHealth O Meter Nike Sports Marketing Nike Sports Marketing Hoechst Marion Roussel, Inc.Hoechst Marion Roussel, Inc. Slim Fast Foods Co. Slim Fast Foods Co. Merck-Medco Managed Merck-Medco Managed Quaker Oats Co. Quaker Oats Co. Care, IncCare, Inc

• There is a long period of glucose intolerance that There is a long period of glucose intolerance that precedes the development of diabetesprecedes the development of diabetes

• Screening tests can identify persons at high risk Screening tests can identify persons at high risk

• There are safe, potentially effective There are safe, potentially effective interventions that can address modifiable risk interventions that can address modifiable risk factorsfactors

Feasibility of Preventing Feasibility of Preventing Type 2 DiabetesType 2 Diabetes

Modifiable Risk Factors for Modifiable 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

To prevent or delay the development To prevent or delay the development

of type 2 diabetes in persons with of type 2 diabetes in persons with

impaired glucose tolerance (IGT)impaired glucose tolerance (IGT)

DPP Primary GoalDPP Primary Goal

DPP Secondary GoalsDPP Secondary Goals

• Reduce cardiovascular disease Reduce cardiovascular disease

(CVD) events(CVD) events

• Reduce CVD risk factorsReduce CVD risk factors

• Reduce atherosclerosisReduce atherosclerosis

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 training Staff training –Data quality control programData quality control program

Diabetes Prevention Program ClinicsDiabetes Prevention Program Clinics

..

.

..

.

.

. ..

. .

. ..

.

.... ..

.. ..

• Age Age >> 25 years 25 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 index Body 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

Screening and RecruitmentScreening and Recruitment

Step 1 Step 1 screeningscreening

Step 2 Step 2 OGTTOGTT

Step 3 Step 3 start run-instart run-in

Step 4 Step 4 randomizationrandomization

Number of participantsNumber of participants

158,177158,177

30,98530,985

4,7194,719

4,0804,080

3,819*3,819*

Step 3 Step 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)

Study InterventionsStudy InterventionsEligible participantsEligible participants

RandomizedRandomized

Standard lifestyle recommendationsStandard lifestyle recommendations

Intensive Metformin PlaceboIntensive Metformin PlaceboLifestyleLifestyle(n = 1079) (n = 1073) (n = 1082)(n = 1079) (n = 1073) (n = 1082)

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

– FPG FPG >> 126 mg/dL (7.0 mmol/L) or 126 mg/dL (7.0 mmol/L) or– 2-hr 2-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, confirmed 126 mg/dL, confirmed

Lifestyle InterventionLifestyle Intervention

An intensive program with the An intensive program with the following specific goals:following specific goals:

• >> 7% loss of body weight and maintenance of 7% 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 activity 150 minutes per week of physical activity

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

The Core CurriculumThe Core Curriculum• 16 session course conducted over 24 weeks16 session course conducted over 24 weeks

• Education and training in diet and exercise methods and Education and training in diet and exercise methods and behavior modification skills behavior modification skills

• Emphasis on:Emphasis on:– Self monitoring techniquesSelf monitoring techniques– Problem solvingProblem solving– Individualizing programs Individualizing programs – Self esteem, empowerment, and social supportSelf esteem, empowerment, and social support– Frequent contact with case manager and DPP support Frequent contact with case manager and DPP support

staffstaff

Post Core ProgramPost Core Program

• Self-monitoring and other behavioral strategies Self-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 motivational campaigns Periodic group classes and motivational campaigns

• Tool box strategies Tool box strategies

– Provide exercise videotapes, pedometersProvide exercise videotapes, pedometers

– Enroll in health club or cooking classEnroll in health club or cooking class

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

Metformin- 850 mg per day escalating after Metformin- 850 mg per day escalating after

4 weeks to 850 mg twice per day4 weeks to 850 mg twice per day

Placebo- Metformin placebo adjusted in Placebo- Metformin placebo adjusted in

parallel with active drugsparallel with active drugs

Interventions:Interventions:MedicationsMedications

DPP PopulationDPP Population

CaucasianCaucasian 1768 (55%)1768 (55%)

AfricanAfricanAmericanAmerican645 (20%)645 (20%)

HispanicHispanicAmericanAmerican508 (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

DPP PopulationDPP Population

Sex DistributionSex Distribution Age DistributionAge Distribution

25-44 31%

> 60 20%

45-59 49%

Men32%

Women68%


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

Lifestyle Intervention:Lifestyle Intervention: Physical Activity Results Physical Activity Results

• 74% of volunteers assigned to 74% of volunteers assigned to

intensive lifestyle achieved the intensive lifestyle achieved the

study goal of study goal of >> 150 minutes of 150 minutes of

activity per week at 24 weeksactivity per week at 24 weeks


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

-hou

rs/w

eek

PlaceboMetformin

Lifestyle


-8

-6

-4

-2

0

0 1 2 3 4


Wei

ght C

hang

e (k

g)

Placebo

Metformin

Lifestyle

Mean Weight ChangeMean Weight Change


Percent Taking Percent Taking >> 80% of Prescribed 80% of Prescribed Dose of Coded MedicationDose of Coded Medication

0

20

40

60

80

100

1 2 3 4


% o

f P

art

icip

an

ts

Metformin

Placebo


0 1 2 3 4

0

10

20

30

40Placebo (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 participants

All participants

Years from randomization

Cu

mu

lativ

e in

cid

en

ce (

%)

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 Diabetes Incidence of Diabetes

Risk reductionRisk reduction31% by metformin31% by metformin58% by lifestyle58% by lifestyle


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 incidence in incidence -------- 31% 58% 31% 58%

compared with placebocompared with placebo

Number needed to treatNumber needed to treat -------- 13.9 13.9 6.9 6.9

to prevent 1 case in 3 yearsto prevent 1 case in 3 years


Mean Change in Fasting Plasma GlucoseMean Change in Fasting Plasma Glucose

100

105

110

115

0 1 2 3 4


FPG

(mg/

dl)

Placebo

MetforminLifestyle


Mean Change in HbAMean Change in HbA1c1c

5.8

5.9

6.0

6.1

0 1 2 3 4


HbA

1c (%

)

Placebo

MetforminLifestyle


0

4

8

12

Male (n=1043) Female (n=2191)

Ca

se

s/1

00

pe

rso

n-y

r

Lifestyle

Metformin

Placebo

Diabetes Incidence Rates by SexDiabetes Incidence Rates by Sex


0

4

8

12

25-44 (n=1000) 45-59 (n=1586) > 60 (n=648)

Ca

se

s/1

00

pe

rso

n-y

r

Lifestyle Metformin Placebo

Diabetes Incidence Rates by AgeDiabetes Incidence Rates by Age

Age (years)


Diabetes Incidence Rates by EthnicityDiabetes Incidence Rates by Ethnicity

0

4

8

12

Caucasian(n=1768)

AfricanAmerican(n=645)

Hispanic(n=508)

AmericanIndian

(n=171)

Asian(n=142)

Cases/1

00 p

ers

on

-yr

Lifestyle Metformin Placebo


0

4

8

12

16

24 - < 30 30 - < 35 > 35

Ca

se

s/1

00

pe

rso

n-y

r Lifestyle Metformin Placebo

(n=1045) (n=995) (n=1194)

Diabetes Incidence Rates by BMIDiabetes Incidence Rates by BMI

Body Mass Index (kg/m2)


0

5

10

15

20

95-109 (5.3- 6.0)(n=2174)

110-125 (6.1-6.9)(n=1060)

Ca

se

s/1

00

pe

rso

n-y

r

Lifestyle

Metformin

Placebo

Diabetes Incidence Rates by Fasting GlucoseDiabetes Incidence Rates by Fasting Glucose

Fasting Plasma Glucose: mg/dl (mmol/l)


0

4

8

12

16

140-153(n=1049)

154-172(n=1103)

173-199(n=1082)

Ca

se

s/1

00

pe

rso

n-y

r Lifestyle Metformin Placebo

Diabetes Incidence Rates by 2-hr GlucoseDiabetes Incidence Rates by 2-hr Glucose

2-Hour Plasma Glucose (mg/dl)


Consistency of Treatment EffectsConsistency of Treatment Effects

• Lifestyle intervention was beneficial Lifestyle intervention was beneficial regardless of ethnicity, age, BMI, or sexregardless of ethnicity, age, BMI, or sex

• The efficacy of lifestyle relative to metformin The efficacy of lifestyle relative to metformin was greater in older persons and in those with was greater in older persons and in those with lower BMI lower BMI

• The efficacy of metformin relative to placebo The efficacy of metformin relative to placebo was greater in those with higher baseline was greater in those with higher baseline fasting glucose and BMI fasting glucose and BMI

0

20

40

60

80

1 2 3 4


%Lifestyle Metformin Placebo

Normal Fasting Glucose at Annual VisitsNormal Fasting Glucose at Annual Visits


0

20

40

60

1 2 3 4



Normal 2-hr Glucose at Annual VisitsNormal 2-hr Glucose at Annual Visits


0

10

20

30

40

50

1 2 3 4



Normal Fasting & 2-hr Glucose at Annual VisitsNormal Fasting & 2-hr Glucose at Annual Visits


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

%



Normal Fasting GlucoseNormal Fasting Glucose

Normal Fasting & 2-hr GlucoseNormal Fasting & 2-hr Glucose

Normal 2-hr GlucoseNormal 2-hr Glucose

LifestyleLifestyle

MetforminMetformin

PlaceboPlacebo


Adverse Events Adverse 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

* *

*


Summary-1Summary-1

• Both interventions were well accepted Both interventions were well accepted and safeand safe

• Intensive lifestyle resulted in weight Intensive lifestyle resulted in weight

loss and increased activity level for the loss and increased activity level for the duration of the studyduration of the study

Summary-2Summary-2

• Both interventions were effective in Both interventions were effective in men and women and all ethnic groupsmen and women and all ethnic groups

• Intensive lifestyle intervention was Intensive lifestyle intervention was effective in all age groups, including effective in all age groups, including

those those >> 60 years of age 60 years of age

Summary-3Summary-3

• Intensive lifestyle intervention reduced Intensive lifestyle intervention reduced the development of diabetes by 58%the development of diabetes by 58%

• Metformin reduced the development of Metformin reduced the development of diabetes by 31%diabetes by 31%

• Lifestyle was more effective than Lifestyle was more effective than metforminmetformin

THANK YOU

Diabetes Prevention Program

Baseline Characteristics

Participant Characteristics by Participant 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

Participant Characteristics by Participant 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


Demographic and Socioeconomic Demographic and Socioeconomic Characteristics by Sex (1)Characteristics by Sex (1)

* n, (%)

nAge (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



* 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



* 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



* 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%)

Female2,191

Overall3,234

Male1,043


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

HispanicAmerican

Indian

2,191 1,160 480 341

Asian American

167 20 83

151 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

HispanicAmerican

Indian

2,191 1,160 480 341

African American

165

Overall

1,043

Caucasian

608


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 ± 0.4range 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 ± 0.9range 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 ± 0.4range 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 ± 0.4range 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 ± 0.9range 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 ± 0.4range 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

HispanicAmerican

Indian

2,191 1,160 480 341

Asian American

167 20 83

151 59


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

HispanicAmerican

Indian

2,191 1,160 480 341

African American

165

Overall

1,043

Caucasian

608 167


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

HispanicAmerican

Indian

2,191 1,160 480 341

African American

165

Overall

1,043

Caucasian

608 167


the diabetes prevention program a randomized clinical trial to

Health & Medicine

offices national center

aging national center

minority health

gcrc programnational

research resources

center wake forest univ

texas health science

school of medicinewashington