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DiabetesDiabetes--What Do You Need to DoWhat Do You Need to Do

Tim Church, M.D., M.P.H., Ph.D.John S. McIlhenny Endowed Chair

Pennington Biomedical Research Center

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Common Myth:Common Myth:You have to run a marathon You have to run a marathon

b fi f lb fi f lto benefit from regular to benefit from regular physical activity !physical activity !

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Fitness TestingFitness Testing

• Maximal exercise test on a treadmill (Balke)

• Standardized fitness categories based on age, S a da d ed ess ca ego es based o age,gender & time on treadmill:

• Fitness => measure of physical activity habits

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Fitness Fitness ClassificationsClassifications

L Fi “U fi ”• Low Fitness = “Unfit”– Lower 20% time on treadmill for gender and age

M d t Fit• Moderate Fitness-– Next 40% time on treadmill for gender and age

– @150 minutes of walking per week

• High Fitness-– Highest 40% time on treadmill for gender and age

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CVD Mortality Rates by Fitness: CVD Mortality Rates by Fitness: Aerobic Center Longitudinal Study (ACLS)

10,0

00

year

s

LowModerateHigh

Dea

ths

per

per

son-y

Women Men

Blair SN et al. JAMA 1989;262:2395-2401.

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Fitness and All-Cause Mortality, ACLS Men, 1970-1989

250

300

PY

95% Upper Limit

150

200

250

Rat

e p

er 1

0,00

0

95% Upper Limit

Adjusted Death Rate

95% Lower Limit

Expected RelationExpected Relation

50

100

Ad

just

ed D

eath

R

0

0 5 10 15 20 25 30

GXT Test Performance (minutes)

A

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Fitness and All-Cause Mortality, ACLS Men, 1970-1989

250

300

PY

95% Upper Limit

150

200

250

Rat

e p

er 1

0,00

0

95% Upper Limit

Adjusted Death Rate

95% Lower Limit

Expected Relation

50

100

Ad

just

ed D

eath

R

0

0 5 10 15 20 25 30

GXT Test Performance (minutes)

A

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CVD Mortality by Fitness CVD Mortality by Fitness Men with DiabetesMen with Diabetes

160r)

80

100

120

140

(per

10K

man

-yea

r

0

20

40

60

CV

D D

eath

Rat

e (

Church et al, Arch Int Med, 2005

0<7 7 to 7.9 8 to 8.9 9 to 9.9 10 to

10.911 t

o11.912 to12.9

>13

Mets

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Diabetes Diabetes Incidence Rates Incidence Rates By By Fitness Groups, Men (n=8633)Fitness Groups, Men (n=8633)

5.9

5

6

7

e/10

00 m

en

2.7

1.6

1

2

3

4

iab

etes

inci

den

ce

0Low Moderate High

Wei M et al. Ann Int Med 1999

Cardiorespiratory Fitness Groups

Di

10

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Diabetes Incidence Rates by Diabetes Incidence Rates by Fitness: ACLS (n =13,190)Fitness: ACLS (n =13,190)

25

30

35

40

00

0 m

an

-yrs

P trend < 0.0001

5

10

15

20

Ra

te p

er

1,0

0<8.0 8.0-

8.99.0-9.9

10.0-10.9

11.0-11.9

12.0-12.9

13.0-13.9

14.0-14.9

≥15.0

Maximal METsunpublished

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Health Benefits of Aerobic & Resistance Training in Individuals g

with Diabetes:

HART-D

Tim Church, M.D., M.P.H., Ph.D.Pennington Biomedical Research Center

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Most national organizations Most national organizations recommend individuals withrecommend individuals withrecommend individuals with recommend individuals with

diabetesdiabetes participate in exercise participate in exercise program composed of a program composed of a

combination of aerobic and combination of aerobic and resistance training for maximal resistance training for maximal

health benefitshealth benefitshealth benefitshealth benefits

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Effect of Exercise Type on HbA1cEffect of Exercise Type on HbA1cN =251 & 6 month interventionN =251 & 6 month intervention

Sigal, RJ et al. Ann Intern Med. 2007 ;147(6):357-69.

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Effect of Exercise Type on HbA1cEffect of Exercise Type on HbA1cN =251N =251

•Primarily Caucasian (92%)a y Caucas a (9 %)•70% Men•No insulin users•Fairly healthy participants

Sigal, RJ et al. Ann Intern Med. 2007 ;147(6):357-69.

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Exercise PrescriptionExercise PrescriptionSigal et al

Aerobic 135 min/wk

Resistance 135 min/wk

Combo 270 min/wk

Was it the combination of AT & RT or time?

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HARTHART--DD

• NIDDK funded

• Primary Outcomes Published– Church et al JAMA Nov 24 2010– Church et al, JAMA Nov 24 2010

• Participants:– Sedentary individuals with diabetes – HbA1c: >6.5% but <11.0%– Tried to be VERY inclusive

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HARTHART--DD• Compare benefit to HbA1c of:

– Control group– Control group• Stretching

– Aerobic training (AT)• 12 kcal/kg/week

R i t t i i (RT)– Resistance training (RT)• 3 days per week: 21 sets per day

– Combination of RT & AT (Combo)• 10 kcal/kg/week & 1 set of 9 RT 2 days/week

• 9 Month Intervention• All exercise supervised (@ 20K sessions)

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HARTHART--DD

• Primary Outcomes:–Hemoglobin A1c

• Secondary Outcomes:• Secondary Outcomes:–Fitness and strength

–DEXA

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Telephone screens

n = 2421

Randomized

n = 262

Completed assessment(n = 1,924)

Control n = 41

RT n = 73

AT n = 72

Combo n = 76

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STOPPED ENROLLMENT

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ParticipantsParticipantsAge Mean (SD) 55.8 (8.7)

Female 63.0%

Ethnicity/race, %

African-American 43.5%

White 52.7%

Other 3.8%Other 3.8%

Body Mass Index 34.9 (5.9)

Waist Circumference, cm 112 (13.8)

Relative VO2, mL/kg/min 19.2 (4.2)

METs 6 9 (1 3)METs 6.9 (1.3)

HbA1c, %Duration Diabetes, years

7.7 (1.0)7.1 (5.5)

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ParticipantsParticipantsAntidepressant Medication 18%

Previous Myocardial Infarction 2%

Previous Cardiac Catheterization 18%

Coronary Artery By-Pass 5.0%

Neuropathy 17.6%

Low-density Lipoprotein 96 (29)

High-density Lipoprotein 49 (11)

Cholesterol Medications 64%

Systolic BP, mmHg 126 (13)

Diastolic BP, mmHg 76 (8)

Blood Pressure Medications 79%

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HartHart--D DM Medication UseD DM Medication UseAny 97.3

Biguanides (metformin) 65%

Sulfonylureas (glipizide) 24%

Thiazolidinediones (glitazones) 18%

Combination Drugs 16%Combination Drugs 16%

Incretin Mimetics (exenatide) 10%

DPP-4 Inhibitors (sitagliptin) 5%

Meglitinides 3%

Insulin 18%

TOTAL (combo counted 2X) 176%

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Retention & ComplianceRetention & Compliance

R t ti 94% ith f ll d t• Retention: 94% with follow-up data–All participants used in analysis

• Compliant (>70% adherence):p ( )–Aerobic: 72%

–Resistance Training: 82%

C b 82%–Combo: 82%

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HARTHART D I t ti D I t ti HARTHART--D Intervention D Intervention DataData

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RT GroupRT Group

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Resistance: Combo GroupResistance: Combo Group

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Aerobic Group 1 2 4 5 7 8 9

Sessions/Week 3.0 3.1 3.1 3.1 3.1 3.1 3.0

I t it % k V02

Aerobic Training: AT & ComboAerobic Training: AT & Combo

3x/wkM d/ViIntensity, % peak V02 60.1 64.3 64.8 64.5 66.9 66.7 65.6

Speed, MPH 2.9 3.1 3.1 3.1 3.1 3.1 3.1

Grade, % 2.0 3.7 5.0 5.4 6.0 6.1 6.8

Mean METs level 4.1 5.0 5.6 5.8 6.0 6.1 6.4

Time, min/wk123.4 140.0 127.7 122.3 115.0 118.3 112.9

Mod/VigSpeed ~Grade ↑METs ↑Time ↓

Combo Group

Sessions/Week 3.0 3.0 3.0 3.0 3.0 3.0 3.0

Intensity, % peak VO2 58.5 63.6 65.8 65.4 64.8 65.4 66.1

Speed, MPH 2.8 3.0 3.1 3.1 3.1 3.1 3.1

↓

Grade, % 1.8 3.5 4.8 5.1 5.6 5.7 6.0

Mean METs level 3.9 4.7 5.4 5.5 5.8 5.9 6.0

Time, min/wk102.4 125.2 108.6 106.6 103.7 101.3 101.4

Month 3 & 6 removed for presentation purposes

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METMET--Minutes/WeekMinutes/Week

2008PhysicalActivity

Recs

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Time ExercisingTime Exercising

Resistance 141 min/wk

Aerobic 140 (130 -150) min/wkAerobic 140 (130 150) min/wk

Combo RT: 30-40 min/wk

AT: 110 (100-120) min/wk

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HARTHART--D Intervention D Intervention Goals Achieved!!!Goals Achieved!!!Goals Achieved!!!Goals Achieved!!!

• Total exercise time similar across groups

• Delivered aerobic interventions that met current recommendations

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Steps per Day: Exercise GroupsSteps per Day: Exercise Groups

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Steps per Day: Exercise GroupsSteps per Day: Exercise Groups

No change in caloric i k d bintake as assessed by FFQ

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HARTHART D O tD O tHARTHART--D OutcomeD OutcomeDataData

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HbA1c by Month and GroupHbA1c by Month and Group

Intention-toTreat Analysis (n=262)

7.60

7.70

7.80Intention toTreat Analysis (n 262)

Control

7 30

7.40

7.50

Hb

A1c

, % Resistance

Aerobic

Combo

7.20

7.30

0 1 2 3 4 5 6 7 8 9

Month

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Control Subtracted Change in Control Subtracted Change in HbA1c after 9 monthsHbA1c after 9 months

P = 0.03

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HbA1c: Baseline > 7.0% & PPTHbA1c: Baseline > 7.0% & PPT

P = 0.002P = 0.04

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Improve HbA1c Improve HbA1c ≥ 0.5% or≥ 0.5% orDecrease DM MedicationsDecrease DM Medications

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Strength TestingStrength Testing

*

*

*Different from all other groups

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METs: From Speed & GradeMETs: From Speed & Grade

Sig vs. Control & RT

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Waist CircumferenceWaist Circumference

All Sig Vs Control

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WeightWeight

Sig. vs Control & RT

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DEXA DataDEXA Data

Sig. Vs. Control

Sig. Vs. Control &

AT

Sig. Vs. AT & Combo

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SummarySummaryFor a given amount of time……• a physical activity program composed of aerobic• a physical activity program composed of aerobic

and resistance is superior to either activities alone– Blood sugar control– Fitness– Fat Mass

The HART-D combination program consisted of: 110 minutes per week of mod/vig intensity walkingp g y g 2 days of 9 resistance training exercises each 10 to 12 repetitions per exercise ~20 minutes per day

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How Do My Recommendations How Do My Recommendations (opinions) Compare to New (opinions) Compare to New ( p ) p( p ) p

Federal Guidelines?Federal Guidelines?

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www.health.gov/paguidelines

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30 minutes