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LIFESTYLE MODIFICATION IN THE
PREVENTION OF TYPE 2 DIABETES:
THE EXPERIENCE WITH THE
DIABETES PREVENTION PROGRAM
AND LOOK AHEAD STUDIES
Edward S Horton, MD
Joslin Diabetes Center
Harvard Medical School
Boston, MA
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Global Projections for the Diabetes Epidemic:
2003-2025 (in Millions)
Adapted from Diabetes Atlas Committee. Diabetes Atlas 2nd Edition: IDF 2003
48.4
58.6
21%
Europe
19.2
39.4
105%
Eastern
Mediterranean
and Middle
East
111%
7.1
15.0
Africa
23.0
36.2
57%
North
America
14.2
26.2
85%
South and
Central
America
39.3
81.6
108%
South-East
Asia
43.0
75.8
76%
Western
pacific
2003
2025
194
333
72%
World
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Global Projections for the Diabetes Epidemic:
2011-2030 (in Millions)
Adapted from Diabetes Atlas Committee. Diabetes Atlas 5th Edition: IDF 2011
52.6 64.0
22%
Europe
90%
14.7
28.0
Africa
37.7
51.2
36%
North
America
and
Carribean
25.1
39.9
59%
South and
Central
America
366.2
551.8
51%
World
71.4
120.9
69%
South-East
Asia
2011
2030
131.9
187.9
42%
Western
Pacific
32.8
59.7
83%
Middle East
and North
Africa
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Age-adjusted relative risk of type 2 diabetes
Obesity Is the Primary Risk Factor for Type 2 Diabetes
1Chan JM et al. Diabetes Care 1994;17:961-9
2Colditz G et al. Ann Intern Med 1995;122:481-6
Body mass index (kg/m2)
0
25
50
75
100
1.0
8.1
40.3
93.2
<22 25 31 35
Women2
0
10
20
30
40
50
1.0
2.2
11.6
42.1
<23 25 31 35
Men1
Relativerisk
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The Dual Epidemic: Obesity and Diabetes
 65% of adult Americans are overweight (BMI >25 kg/m2) and
32% are obese (BMI >30 kg/m2).
 34% have the metabolic syndrome (NCEP-ATP III criteria).
 There are now an estimated 25.8 million people with
diabetes in the USA (11.3% of adults) and 79 million with
pre-diabetes (IFG/IGT).
 The lifetime risk of developing diabetes for people born in
2000 is 33% for men and 39% for women. For Hispanic
women it is 50%.
 In this population cardiovascular disease is the major cause
of mortality.
IFG: Impaired fasting glucose
IGT: Impaired glucose tolerance
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Changes in our lifestyle!
What is driving the dual
epidemic?
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Source: www.myhealthywaist.org
Prevention and Treatment of Diabetes
A major goal of treatment of
pre-diabetes and diabetes is to
prevent both the microvascular
and the macrovascular
complications!
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Trials to Prevent / Delay Progression from Impaired
Glucose Tolerance to Type 2 Diabetes
Lifestyle changes
 Malmo Study
 Da Qing Study
 Finnish Diabetes
Prevention Study
 Diabetes Prevention
Program
Medications
 Diabetes Prevention Program:
metformin, (troglitazone)
 TRIPOD: troglitazone
 STOP-NIDDM: acarbose
 NAVIGATOR: nateglinide and valsartan
 DREAM: rosiglitazone and ramipril
 XENDOS: orlistat
 ORIGIN: glargine insulin
 ACT NOW: pioglitazone
 Voglibose Study
ACT NOW: Actos Now for Prevention of Diabetes
DREAM: Diabetes Reduction Approaches with Ramipril and Rosiglitazone
NAVIGATOR: Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research
ORIGIN: Outcomes Reduction with Initial Glargine Introduction
STOP-NIDDM: Study to Prevent Non–Insulin-Dependent Diabetes Mellitus
TRIPOD: Troglitazone in Prevention of Diabetes Study
XENDOS: Xenical in the Prevention of Diabetes in Obese Subjects
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Summary of Medication Trials to Prevent Type 2 Diabetes
 AGIs (STOP-NIDDM, Voglibose)
 Metformin (Diabetes Prevention Program)
 TZDs (TRIPOD, DREAM, ACT NOW)
The major concerns are long-term safety, tolerance, efficacy
and cost-effectiveness of medications:
 AGIs: gastrointestinal side effects
 Metformin: gastrointestinal side effects
 TZDs: weight gain, fluid retention, cardiovascular disease, fractures
25-40%
31%
55-80%
ACT NOW: Actos Now for Prevention of Diabetes
AGIs: alpha-glucosidase inhibitors
DREAM: Diabetes Reduction Approaches with Ramipril and Rosiglitazone
RRR: Relative risk reduction
STOP-NIDDM: Study to Prevent Non–Insulin-Dependent Diabetes Mellitus
TRIPOD: Troglitazone in Prevention of Diabetes Study
TZDs: thiazolidinediones
RRR
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A randomized clinical trial to prevent type 2
diabetes in persons at high risk
Sponsored by the NIH, NIDDK,
NIA, NICHD, IHS, CDC, ADA and other agencies and corporations
The Diabetes Prevention Program (DPP)
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Study Population
Adapted from Knowler WC et al. N Engl J Med 2002;346:393-403
55%
20%
16%
4% 5%
Caucasian
African-American
Hispanic-American
Asian-American & Pacific Islander
American Indian
Total
1768
645
508
142
171
3234
Caucasian
African-American
Hispanic-American
Asian
American Indian
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Study Interventions
Standard lifestyle recommendations
Intensive lifestyle Metformin Placebo
Randomized
Eligible participants
(n=1079) (n=1073) (n=1082)
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Intensive lifestyle goals
 Reduction of fat and calorie intake
 Physical activity at least 150 minutes/week
 Achieve and maintain at least 7% weight loss
Metformin goals
Lifestyle & Metformin Interventions
 Metformin 850 mg twice daily
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Study Timeline
Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86
June 1996 December 2013
1998 2000 2002 2004 2006 2008 2010 2012
DPP
recruitment
began
1996 DPP
enrollment
completed
1999 DPP
results
2001
DPPOS
began
2002
DPPOS
midpoint
results
2009
DPPOS
visits end
2013
DPP: Diabetes Prevention Program
DPPOS: Diabetes Prevention Program Outcomes Study
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Mean Weight Change
-8
-6
-4
-2
0
0 1 2 3 4
Changeinweight(kg)
Years from randomization
Adapted from Knowler WC et al. N Engl J Med 2002;346:393-403
Placebo
Metformin
Lifestyle
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Mean Change in Leisure Physical Activity
0
2
4
6
8
0 1 2 3 4
Changeinphysicalactivity
(MET-hours/week)
Years from randomization
Adapted from Knowler WC et al. N Engl J Med 2002;346:393-403
Placebo
Metformin
Lifestyle
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Adapted from Orchard TJ et al. Ann Intern Med 2005;142:611-9
0
10
20
30
40
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0
Study year
Cumulativeincidence
ofdiabetes(%)
Incidence of Diabetes
Placebo: n=1082
Metformin: n=1073, p<0.001 vs. placebo
Lifestyle: n=1079, p<0.001 vs. metformin, p<0.001 vs. placebo
Risk reduction
31% by metformin
58% by lifestyle
Placebo
Metformin
Lifestyle
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Metabolic Syndrome  NCEP-ATP III Clinical Criteria
(3 of 5)
Adapted from Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults
JAMA 2001;285:2486-97
Obesity
(esp. abdominal
obesity)
Waist circumference
Men: ≥102 cm (40 in)
Women: ≥88 cm (35 in)Atherogenic
dyslipidemia
 Triglycerides
≥1.69 mmol/l
 HDL cholesterol
Men: <1.03 mmol/l
Women: <1.29 mmol/l
Elevated blood
pressure
Insulin resistance
Fasting glucose
≥5.6 mmol/l (modified)
Pro-thrombotic state
Pro-
inflammatory
state
≥130/85 mmHg
Genetic variation in
cardiovascular disease
risk factor regulation
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 1711 (53%) of the 3234 participants had the
syndrome at randomization.
 Prevalence of the syndrome did not vary by
gender or age group (<45, 45-64, 65+ years).
 Prevalence did vary by ethnicity, being lowest in
Asians (41%) and highest in Caucasians (57%).
 Prevalence of the individual components did
vary by ethnicity and by age group.
Prevalence of Metabolic Syndrome at Randomization
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Cumulative Incidence of Metabolic Syndrome by Treatment Group
Adapted from Orchard TJ et al. Ann Intern Med 2005;142:611-9
0.00
0.15
0.30
0.45
0.60
0.75
Cumulativeincidenceof
metabolicsyndrome(%)
Time since randomization (years)
1 2 3 40
Risk reduction:
17%* by metformin
41%** by lifestyle
Lifestyle vs. metformin 29%**
Placebo n=490
Metformin n=503
Lifestyle n=530
* p<0.05
** p<0.001
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Three-Year Incidence of Components by Treatment Group
Adapted from Orchard TJ et al. Ann Intern Med 2005;142:611-9
*p<0.001 comparison vs. placebo
Placebo
(%)
Metformin
(%)
Lifestyle
(%)
High waist circumference 33 15* 8*
Low HDL cholesterol 70 67 68
High triglycerides 27 30 18*
High fasting plasma
glucose
40 29* 28*
High blood pressure 41 44 35*
Source: www.myhealthywaist.org
 Hypertension was present in 30% of subjects at
baseline; over 3 years it increased in the placebo
and metformin groups, but significantly decreased in
the intensive lifestyle group.
 Triglycerides decreased in all groups, but fell
significantly more in intensive lifestyle group.
 Intensive lifestyle group significantly increased HDL
cholesterol and decreased LDL phenotype B.
 After 3 years, the use of medications to achieve
targets for hypertension was 27-28% less and for
dyslipidemia was 25% less in the intensive lifestyle
group.
Key Findings
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DPPOS midpoint follow-up after 7 years
Time since original DPP randomization (10 years)
Study Timeline
Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86
June 1996 December 2013
1998 2000 2002 2004 2006 2008 2010 2012
DPP
recruitment
began
1996 DPP
enrollment
completed
1999 DPP
results
2001
DPPOS
began
2002
DPPOS
midpoint
results
2009
DPPOS
visits end
2013
DPP: Diabetes Prevention Program
DPPOS: Diabetes Prevention Program Outcomes Study
Source: www.myhealthywaist.org
 Diabetes delay or prevention.
 Prevention of diabetes complications
such as kidney, eye and nerve
problems, and heart disease.
Diabetes Prevention Program Outcomes Study
(DPPOS) Goals
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 Original Placebo group
 HELP classes four times a year
 Original Metformin group
 Metformin 850 mg twice daily
 HELP classes four times a year
 Original Lifestyle group
 HELP classes four times a year
 Boost lifestyle classes twice a year
Diabetes Prevention Program Outcomes Study
(DPPOS) Treatments
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Weight Change Over Time
Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86
Changeinweight(kg)
Year since DPP randomization
-2
-4
-6
-8
0
0 2 4 6 8 10
Placebo
Metformin
Lifestyle
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Diabetes Prevention Program Outcomes Study (DPPOS)
Incidence of Diabetes
Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86
Cumulativeincidence(%)
Year since DPP randomization
40
30
10
0
50
0 2 4 6 8 10
60
20
Placebo
Metformin
Lifestyle
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Diabetes Prevention Program Outcomes Study (DPPOS)
Incidence of Diabetes
Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86
Cumulativeincidence(%)
Year since DPP randomization
40
30
10
0
50
0 2 4 6 8 10
60
20
Risk reduction:
18% with metformin
34% with lifestyle
Placebo
Metformin
Lifestyle
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Diabetes Prevention Program (DPP) vs. Diabetes Prevention
Program Outcomes Study (DPPOS) Diabetes Rates
Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86
0
2
4
6
8
10
12
DPP (n=3234) DPPOS (n=1994)
Cruderateper100person-years Placebo
Metformin
Lifestyle
Source: www.myhealthywaist.org
 Original Lifestyle participants continue to
develop diabetes at the lower rate they
developed diabetes during Diabetes Prevention
Program (DPP).
 Original Placebo and Metformin participants
have lowered their rate of diabetes development
to a similar rate as the Lifestyle group.
Diabetes Development in Diabetes Prevention Program
Outcomes Study (DPPOS)
Source: www.myhealthywaist.org
 Delay in diabetes onset after 10 years of follow-up:
 4 years for Lifestyle group
 2 years for Metformin group
 The lower rate of diabetes development for lifestyle and
metformin during Diabetes Prevention Program (DPP)
means:
 Original Lifestyle participants have a 34% lower risk of
diabetes compared to Placebo participants.
 Original Metformin participants have a 18% lower risk
of diabetes compared to Placebo participants.
Diabetes Prevention Program Outcomes Study (DPPOS)
Diabetes Risk Reduction
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Use of Anti-Diabetic Medicines
Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86
Useofantidiabetic
medications(%)
Year since DPP randomization
20
15
5
0
25
0 2 4 6 8 10
30
10
Placebo
Metformin
Lifestyle
Source: www.myhealthywaist.org
AIM:
To determine whether
cardiovascular morbidity
and mortality in persons with
type 2 diabetes can be
reduced through intensive
lifestyle intervention aimed
at producing and
maintaining weight loss.
Look AHEAD Clinical Trial
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Primary Outcome
 The incidence rate of the first post-randomization
occurrence of a composite outcome, including:
 cardiovascular death (fatal myocardial infarction and stroke)
 nonfatal myocardial infarction
 nonfatal stroke
 hospitalization for angina
Over 13.5-year follow-up is reduced in the Intensive
Lifestyle Intervention group compared to Diabetes Support
and Education group.
Source: www.myhealthywaist.org
 All-cause mortality
 Cardiovascular disease risk factors
 Costs and cost effectiveness
 Diabetes control and complications
 General health
 Hospitalizations
 Quality of life and psychological outcomes
Other Outcomes
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Look AHEAD Interventions
 Intensive Lifestyle Intervention (ILI)
 Diabetes Support & Education (DSE)
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Lifestyle Intervention
Phase I: Weight Loss Induction
 Months 1-6
 Weekly contact
 3 group sessions/month
 1 individual session/month
 Personal weight loss goal =10%
 Study weight loss goal ≥7%
Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Recommendations
 Dietary intake
 1200-1500 kcal/day <250 lbs (<113.5 kg)
 1500-1800 kcal/day ≥250 lbs (≥113.5 kg)
 ≤30% calories from fat
 meal replacements
 menu plans
 Physical activity
 gradual increase
 175 min/week
 10,000 steps/day (approx. 5 miles)
Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
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Lifestyle Intervention
Phase II: Weight Loss Maintenance
 Months 7-12
 Reduced contact
 2 group sessions/month
 1 individual session/month
 2 face-to-face contacts/month required;
3 recommended
 Individual weight loss goal
 continue weight loss if <10%
 weight maintenance if ≥10%
Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
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Diabetes Support and Education
 3-4 meetings/year to promote retention
 Health education topics
 diet
 exercise
 social support
Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
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Baseline Characteristics of Participants
Adapted from: Look AHEAD Research Group Obesity (Silver Spring) 2006;14:737-52
and Look AHEAD Research Group Diabetes Care 2007;30:1374-1383
Lifestyle
intervention
(N=2570)
Diabetes support
and education
(N=2575)
Women (%) 59.3 59.6
Age (years) 58.6 58.9
Insulin users (%) 15 16
Baseline BMI (kg/m2) 35.9 36.0
Baseline weight (kg) 100.5 100.9
Baseline waist (cm) 113.8 114.1
History of prior cardiovascular
disease event (%)
15 14
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Assessments
 Annual clinic visits
 Weight, blood pressure, lipids.
 Fitness with maximum treadmill test at baseline
and sub-max at years 1 and 4.
 Participant’s own physician is responsible
for medical care and changes in
medications.
Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Weight Loss at 1 Year
Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383
-9
ILI
0
-1
-2
-3
-4
-5
-6
-7
-8
DSE
p<0.0001
Changeinweight(%)
8.6%
0.7%
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Fitness Change at 1 Year
Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383
0
5
10
15
20
25
Meanfitnesschange(%)
Unadjusted
p<0.001
Adjusted for 1 year
weight change p<0.001
5.8
20.9
10.8
15.9
DSE ILI ILIDSE
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
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1-Year Changes in Markers of Diabetes Control
Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383
Markers of diabetes control ILI DSE p value
Hemoglobin A1c (%), Baseline
Hemoglobin A1c (%), Year 1
Year 1 – Baseline
7.25
6.61
-0.64
7.29
7.15
-0.14
0.26
<0.001
<0.001
Fasting glucose (mmol/l), Baseline
Fasting glucose (mmol/l), Year 1
Year 1 – Baseline
8.4
7.2
-1.2
8.5
8.1
-0.4
0.21
<0.001
<0.001
Diabetes medications (%), Baseline
Diabetes medications (%), Year 1
Year 1 – Baseline
86.5
78.6
-7.8
86.5
88.7
2.2
0.93
<0.001
<0.001
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
1-Year Changes in Markers of Blood Pressure (BP) Control
Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383
Markers of blood pressure control ILI DSE p value
Systolic BP (mmHg), Baseline
Systolic BP (mmHg), Year 1
Year 1 – Baseline
128.2
121.4
-6.8
129.4
126.6
-2.8
0.01
<0.001
<0.001
Diastolic BP (mmHg), Baseline
Diastolic BP (mmHg), Year 1
Year 1 – Baseline
69.9
67.0
-3.0
70.4
68.6
-1.8
0.11
<0.001
<0.001
Antihypertensive medications (%), Baseline
Antihypertensive medications (%), Year 1
Year 1 – Baseline
75.3
75.2
-0.1
73.7
75.9
2.2
0.23
0.54
0.02
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
1-Year Changes in Markers of Lipid Control
Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383
Markers of lipid control ILI DSE p value
LDL cholesterol (mmol/l), Baseline
LDL cholesterol (mmol/l), Year 1
Year 1 – Baseline
2.90
2.77
-0.13
2.91
2.76
-0.15
0.78
0.74
0.49
HDL cholesterol (mmol/l), Baseline
HDL cholesterol (mmol/l), Year 1
Year 1 – Baseline
1.12
1.21
0.09
1.13
1.16
0.04
0.80
<0.001
<0.001
Triglycerides (mmol/l), Baseline
Triglycerides (mmol/l), Year 1
Year 1 – Baseline
2.06
1.72
-0.34
2.03
1.87
-0.16
0.38
<0.001
<0.001
Lipid-lowering medications (%), Baseline
Lipid-lowering medications (%), Year 1
Year 1 – Baseline
49.4
53.0
3.7
48.4
57.8
9.4
0.52
<0.001
<0.001
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Source: www.myhealthywaist.org
Four-Year
Results
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
-9
-8
-7
-6
-5
-4
-3
-2
-1
0
0 1 2 3 4
Percent Weight Change from Baseline
Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75
Weightchangefrombaseline(%)
DSE
ILI
Repeated measures adjusted for clinic and baseline level
P value for average effect across all visits: p<0.0001
Year
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Percent Fitness Change from Baseline
Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75
Fitnesschangefrombaseline(%)
Year
-10
0
10
20
30
0 1 2 3 4
DSE
ILI
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Repeated measures adjusted for clinic and baseline level
P value for average effect across all visits: p<0.0001
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Hemoglobin A1c (HbA1c) Change from Baseline
Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75
HbA1cchangefrombaseline(%)
Year
-0.8
-0.7
-0.6
-0.5
-0.4
-0.3
-0.2
-0.1
0
0 1 2 3 4
DSE
ILI
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Repeated measures adjusted for clinic and baseline level
P value for average effect across all visits: p<0.0001
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Systolic Blood Pressure Change from Baseline
Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75
Systolicbloodpressure
changefrombaseline(mmHg)
Year
-9
-8
-7
-6
-5
-4
-3
-2
-1
0
0 1 2 3 4
DSE
ILI
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Repeated measures adjusted for clinic and baseline level
P value for average effect across all visits: p<0.0001
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
Use of Any Antihypertensive Drug
Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75
Year
No baseline use Baseline use
DSE
N=684
ILI
N=661
p value
DSE
N=1872
ILI
N=1895
p value
1 21.9% 16.4% 0.01 89.9% 81.3% <0.001
2 31.9% 24.7% 0.005 90.4% 81.0% <0.001
3 40.3% 33.3% 0.01 91.2% 82.9% <0.001
4 47.2% 43.0% 0.15 92.7% 85.0% <0.001
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Source: www.myhealthywaist.orgSource: www.myhealthywaist.org
HDL Cholesterol Change from Baseline
Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75
HDLcholesterolchange
frombaseline(mg/dl)
Year
0
1
2
3
4
5
0 1 2 3 4
DSE
ILI
ILI: Intensive Lifestyle Intervention
DSE: Diabetes Support & Education
Repeated measures adjusted for clinic and baseline level
P value for average effect across all visits: p<0.0001
Source: www.myhealthywaist.org
Summary: Four-Year Results of Look AHEAD
 Intensive lifestyle intervention has been effective
in promoting weight loss and improving fitness
through four years of follow-up.
 The intensive lifestyle intervention has produced
sustained improvements in glycemic control,
systolic blood pressure, and HDL cholesterol.
Source: www.myhealthywaist.org
Where Do We Go from Here?
 The DPP/DPPOS ends in 2014 (~2 years).
 Major topics of interest include effects of
interventions on development of micro- and
macrovascular complications of diabetes,
physical and mental function, cancer and
other problems of aging in these high-risk
populations.
Source: www.myhealthywaist.org
Summary
 There is an epidemic of diabetes that is associated
with lifestyle changes and obesity.
 The metabolic syndrome and impaired glucose
tolerance are more prevalent than diabetes.
 The metabolic syndrome and impaired glucose
tolerance are known risk factors for type 2 diabetes
and cardiovascular disease.
 Both lifestyle modification and several medications
are effective in preventing, delaying and treating type
2 diabetes, but their effectiveness in reducing
cardiovascular disease is not yet known.
Source: www.myhealthywaist.org
How Can We Translate These Results into Practice?
 The Why WAIT Program at Joslin.
http://www.joslin.org/care/why_wait.html
 The CDC programs in collaboration with the
YMCA, United Health Care and others.
 The Joslin Initiative with Center for Medicare &
Medicaid Services and others.
 Other community-based initiatives.
Source: www.myhealthywaist.org

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Lifestyle modification in the prevention of type 2 diabetes: The experience with the Diabetes Prevention Program and Look AHEAD studies

  • 1. Source: www.myhealthywaist.org LIFESTYLE MODIFICATION IN THE PREVENTION OF TYPE 2 DIABETES: THE EXPERIENCE WITH THE DIABETES PREVENTION PROGRAM AND LOOK AHEAD STUDIES Edward S Horton, MD Joslin Diabetes Center Harvard Medical School Boston, MA
  • 2. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Global Projections for the Diabetes Epidemic: 2003-2025 (in Millions) Adapted from Diabetes Atlas Committee. Diabetes Atlas 2nd Edition: IDF 2003 48.4 58.6 21% Europe 19.2 39.4 105% Eastern Mediterranean and Middle East 111% 7.1 15.0 Africa 23.0 36.2 57% North America 14.2 26.2 85% South and Central America 39.3 81.6 108% South-East Asia 43.0 75.8 76% Western pacific 2003 2025 194 333 72% World
  • 3. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Global Projections for the Diabetes Epidemic: 2011-2030 (in Millions) Adapted from Diabetes Atlas Committee. Diabetes Atlas 5th Edition: IDF 2011 52.6 64.0 22% Europe 90% 14.7 28.0 Africa 37.7 51.2 36% North America and Carribean 25.1 39.9 59% South and Central America 366.2 551.8 51% World 71.4 120.9 69% South-East Asia 2011 2030 131.9 187.9 42% Western Pacific 32.8 59.7 83% Middle East and North Africa
  • 4. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Age-adjusted relative risk of type 2 diabetes Obesity Is the Primary Risk Factor for Type 2 Diabetes 1Chan JM et al. Diabetes Care 1994;17:961-9 2Colditz G et al. Ann Intern Med 1995;122:481-6 Body mass index (kg/m2) 0 25 50 75 100 1.0 8.1 40.3 93.2 <22 25 31 35 Women2 0 10 20 30 40 50 1.0 2.2 11.6 42.1 <23 25 31 35 Men1 Relativerisk
  • 5. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org The Dual Epidemic: Obesity and Diabetes  65% of adult Americans are overweight (BMI >25 kg/m2) and 32% are obese (BMI >30 kg/m2).  34% have the metabolic syndrome (NCEP-ATP III criteria).  There are now an estimated 25.8 million people with diabetes in the USA (11.3% of adults) and 79 million with pre-diabetes (IFG/IGT).  The lifetime risk of developing diabetes for people born in 2000 is 33% for men and 39% for women. For Hispanic women it is 50%.  In this population cardiovascular disease is the major cause of mortality. IFG: Impaired fasting glucose IGT: Impaired glucose tolerance
  • 6. Source: www.myhealthywaist.org Changes in our lifestyle! What is driving the dual epidemic?
  • 8. Source: www.myhealthywaist.org Prevention and Treatment of Diabetes A major goal of treatment of pre-diabetes and diabetes is to prevent both the microvascular and the macrovascular complications!
  • 9. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Trials to Prevent / Delay Progression from Impaired Glucose Tolerance to Type 2 Diabetes Lifestyle changes  Malmo Study  Da Qing Study  Finnish Diabetes Prevention Study  Diabetes Prevention Program Medications  Diabetes Prevention Program: metformin, (troglitazone)  TRIPOD: troglitazone  STOP-NIDDM: acarbose  NAVIGATOR: nateglinide and valsartan  DREAM: rosiglitazone and ramipril  XENDOS: orlistat  ORIGIN: glargine insulin  ACT NOW: pioglitazone  Voglibose Study ACT NOW: Actos Now for Prevention of Diabetes DREAM: Diabetes Reduction Approaches with Ramipril and Rosiglitazone NAVIGATOR: Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research ORIGIN: Outcomes Reduction with Initial Glargine Introduction STOP-NIDDM: Study to Prevent Non–Insulin-Dependent Diabetes Mellitus TRIPOD: Troglitazone in Prevention of Diabetes Study XENDOS: Xenical in the Prevention of Diabetes in Obese Subjects
  • 10. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Summary of Medication Trials to Prevent Type 2 Diabetes  AGIs (STOP-NIDDM, Voglibose)  Metformin (Diabetes Prevention Program)  TZDs (TRIPOD, DREAM, ACT NOW) The major concerns are long-term safety, tolerance, efficacy and cost-effectiveness of medications:  AGIs: gastrointestinal side effects  Metformin: gastrointestinal side effects  TZDs: weight gain, fluid retention, cardiovascular disease, fractures 25-40% 31% 55-80% ACT NOW: Actos Now for Prevention of Diabetes AGIs: alpha-glucosidase inhibitors DREAM: Diabetes Reduction Approaches with Ramipril and Rosiglitazone RRR: Relative risk reduction STOP-NIDDM: Study to Prevent Non–Insulin-Dependent Diabetes Mellitus TRIPOD: Troglitazone in Prevention of Diabetes Study TZDs: thiazolidinediones RRR
  • 11. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org A randomized clinical trial to prevent type 2 diabetes in persons at high risk Sponsored by the NIH, NIDDK, NIA, NICHD, IHS, CDC, ADA and other agencies and corporations The Diabetes Prevention Program (DPP)
  • 12. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Study Population Adapted from Knowler WC et al. N Engl J Med 2002;346:393-403 55% 20% 16% 4% 5% Caucasian African-American Hispanic-American Asian-American & Pacific Islander American Indian Total 1768 645 508 142 171 3234 Caucasian African-American Hispanic-American Asian American Indian
  • 13. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Study Interventions Standard lifestyle recommendations Intensive lifestyle Metformin Placebo Randomized Eligible participants (n=1079) (n=1073) (n=1082)
  • 14. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Intensive lifestyle goals  Reduction of fat and calorie intake  Physical activity at least 150 minutes/week  Achieve and maintain at least 7% weight loss Metformin goals Lifestyle & Metformin Interventions  Metformin 850 mg twice daily
  • 15. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Study Timeline Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86 June 1996 December 2013 1998 2000 2002 2004 2006 2008 2010 2012 DPP recruitment began 1996 DPP enrollment completed 1999 DPP results 2001 DPPOS began 2002 DPPOS midpoint results 2009 DPPOS visits end 2013 DPP: Diabetes Prevention Program DPPOS: Diabetes Prevention Program Outcomes Study
  • 16. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Mean Weight Change -8 -6 -4 -2 0 0 1 2 3 4 Changeinweight(kg) Years from randomization Adapted from Knowler WC et al. N Engl J Med 2002;346:393-403 Placebo Metformin Lifestyle
  • 17. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Mean Change in Leisure Physical Activity 0 2 4 6 8 0 1 2 3 4 Changeinphysicalactivity (MET-hours/week) Years from randomization Adapted from Knowler WC et al. N Engl J Med 2002;346:393-403 Placebo Metformin Lifestyle
  • 18. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Adapted from Orchard TJ et al. Ann Intern Med 2005;142:611-9 0 10 20 30 40 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 Study year Cumulativeincidence ofdiabetes(%) Incidence of Diabetes Placebo: n=1082 Metformin: n=1073, p<0.001 vs. placebo Lifestyle: n=1079, p<0.001 vs. metformin, p<0.001 vs. placebo Risk reduction 31% by metformin 58% by lifestyle Placebo Metformin Lifestyle
  • 19. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Metabolic Syndrome  NCEP-ATP III Clinical Criteria (3 of 5) Adapted from Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults JAMA 2001;285:2486-97 Obesity (esp. abdominal obesity) Waist circumference Men: ≥102 cm (40 in) Women: ≥88 cm (35 in)Atherogenic dyslipidemia  Triglycerides ≥1.69 mmol/l  HDL cholesterol Men: <1.03 mmol/l Women: <1.29 mmol/l Elevated blood pressure Insulin resistance Fasting glucose ≥5.6 mmol/l (modified) Pro-thrombotic state Pro- inflammatory state ≥130/85 mmHg Genetic variation in cardiovascular disease risk factor regulation
  • 20. Source: www.myhealthywaist.org  1711 (53%) of the 3234 participants had the syndrome at randomization.  Prevalence of the syndrome did not vary by gender or age group (<45, 45-64, 65+ years).  Prevalence did vary by ethnicity, being lowest in Asians (41%) and highest in Caucasians (57%).  Prevalence of the individual components did vary by ethnicity and by age group. Prevalence of Metabolic Syndrome at Randomization
  • 21. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Cumulative Incidence of Metabolic Syndrome by Treatment Group Adapted from Orchard TJ et al. Ann Intern Med 2005;142:611-9 0.00 0.15 0.30 0.45 0.60 0.75 Cumulativeincidenceof metabolicsyndrome(%) Time since randomization (years) 1 2 3 40 Risk reduction: 17%* by metformin 41%** by lifestyle Lifestyle vs. metformin 29%** Placebo n=490 Metformin n=503 Lifestyle n=530 * p<0.05 ** p<0.001
  • 22. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Three-Year Incidence of Components by Treatment Group Adapted from Orchard TJ et al. Ann Intern Med 2005;142:611-9 *p<0.001 comparison vs. placebo Placebo (%) Metformin (%) Lifestyle (%) High waist circumference 33 15* 8* Low HDL cholesterol 70 67 68 High triglycerides 27 30 18* High fasting plasma glucose 40 29* 28* High blood pressure 41 44 35*
  • 23. Source: www.myhealthywaist.org  Hypertension was present in 30% of subjects at baseline; over 3 years it increased in the placebo and metformin groups, but significantly decreased in the intensive lifestyle group.  Triglycerides decreased in all groups, but fell significantly more in intensive lifestyle group.  Intensive lifestyle group significantly increased HDL cholesterol and decreased LDL phenotype B.  After 3 years, the use of medications to achieve targets for hypertension was 27-28% less and for dyslipidemia was 25% less in the intensive lifestyle group. Key Findings
  • 24. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org DPPOS midpoint follow-up after 7 years Time since original DPP randomization (10 years) Study Timeline Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86 June 1996 December 2013 1998 2000 2002 2004 2006 2008 2010 2012 DPP recruitment began 1996 DPP enrollment completed 1999 DPP results 2001 DPPOS began 2002 DPPOS midpoint results 2009 DPPOS visits end 2013 DPP: Diabetes Prevention Program DPPOS: Diabetes Prevention Program Outcomes Study
  • 25. Source: www.myhealthywaist.org  Diabetes delay or prevention.  Prevention of diabetes complications such as kidney, eye and nerve problems, and heart disease. Diabetes Prevention Program Outcomes Study (DPPOS) Goals
  • 26. Source: www.myhealthywaist.org  Original Placebo group  HELP classes four times a year  Original Metformin group  Metformin 850 mg twice daily  HELP classes four times a year  Original Lifestyle group  HELP classes four times a year  Boost lifestyle classes twice a year Diabetes Prevention Program Outcomes Study (DPPOS) Treatments
  • 27. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Weight Change Over Time Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86 Changeinweight(kg) Year since DPP randomization -2 -4 -6 -8 0 0 2 4 6 8 10 Placebo Metformin Lifestyle
  • 28. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Diabetes Prevention Program Outcomes Study (DPPOS) Incidence of Diabetes Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86 Cumulativeincidence(%) Year since DPP randomization 40 30 10 0 50 0 2 4 6 8 10 60 20 Placebo Metformin Lifestyle
  • 29. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Diabetes Prevention Program Outcomes Study (DPPOS) Incidence of Diabetes Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86 Cumulativeincidence(%) Year since DPP randomization 40 30 10 0 50 0 2 4 6 8 10 60 20 Risk reduction: 18% with metformin 34% with lifestyle Placebo Metformin Lifestyle
  • 30. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Diabetes Prevention Program (DPP) vs. Diabetes Prevention Program Outcomes Study (DPPOS) Diabetes Rates Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86 0 2 4 6 8 10 12 DPP (n=3234) DPPOS (n=1994) Cruderateper100person-years Placebo Metformin Lifestyle
  • 31. Source: www.myhealthywaist.org  Original Lifestyle participants continue to develop diabetes at the lower rate they developed diabetes during Diabetes Prevention Program (DPP).  Original Placebo and Metformin participants have lowered their rate of diabetes development to a similar rate as the Lifestyle group. Diabetes Development in Diabetes Prevention Program Outcomes Study (DPPOS)
  • 32. Source: www.myhealthywaist.org  Delay in diabetes onset after 10 years of follow-up:  4 years for Lifestyle group  2 years for Metformin group  The lower rate of diabetes development for lifestyle and metformin during Diabetes Prevention Program (DPP) means:  Original Lifestyle participants have a 34% lower risk of diabetes compared to Placebo participants.  Original Metformin participants have a 18% lower risk of diabetes compared to Placebo participants. Diabetes Prevention Program Outcomes Study (DPPOS) Diabetes Risk Reduction
  • 33. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Use of Anti-Diabetic Medicines Adapted from Diabetes Prevention Program Research Group Lancet 2009;374:1677-86 Useofantidiabetic medications(%) Year since DPP randomization 20 15 5 0 25 0 2 4 6 8 10 30 10 Placebo Metformin Lifestyle
  • 34. Source: www.myhealthywaist.org AIM: To determine whether cardiovascular morbidity and mortality in persons with type 2 diabetes can be reduced through intensive lifestyle intervention aimed at producing and maintaining weight loss. Look AHEAD Clinical Trial
  • 35. Source: www.myhealthywaist.org Primary Outcome  The incidence rate of the first post-randomization occurrence of a composite outcome, including:  cardiovascular death (fatal myocardial infarction and stroke)  nonfatal myocardial infarction  nonfatal stroke  hospitalization for angina Over 13.5-year follow-up is reduced in the Intensive Lifestyle Intervention group compared to Diabetes Support and Education group.
  • 36. Source: www.myhealthywaist.org  All-cause mortality  Cardiovascular disease risk factors  Costs and cost effectiveness  Diabetes control and complications  General health  Hospitalizations  Quality of life and psychological outcomes Other Outcomes
  • 37. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Look AHEAD Interventions  Intensive Lifestyle Intervention (ILI)  Diabetes Support & Education (DSE)
  • 38. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Lifestyle Intervention Phase I: Weight Loss Induction  Months 1-6  Weekly contact  3 group sessions/month  1 individual session/month  Personal weight loss goal =10%  Study weight loss goal ≥7% Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
  • 39. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Recommendations  Dietary intake  1200-1500 kcal/day <250 lbs (<113.5 kg)  1500-1800 kcal/day ≥250 lbs (≥113.5 kg)  ≤30% calories from fat  meal replacements  menu plans  Physical activity  gradual increase  175 min/week  10,000 steps/day (approx. 5 miles) Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
  • 40. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Lifestyle Intervention Phase II: Weight Loss Maintenance  Months 7-12  Reduced contact  2 group sessions/month  1 individual session/month  2 face-to-face contacts/month required; 3 recommended  Individual weight loss goal  continue weight loss if <10%  weight maintenance if ≥10% Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
  • 41. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Diabetes Support and Education  3-4 meetings/year to promote retention  Health education topics  diet  exercise  social support Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
  • 42. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Baseline Characteristics of Participants Adapted from: Look AHEAD Research Group Obesity (Silver Spring) 2006;14:737-52 and Look AHEAD Research Group Diabetes Care 2007;30:1374-1383 Lifestyle intervention (N=2570) Diabetes support and education (N=2575) Women (%) 59.3 59.6 Age (years) 58.6 58.9 Insulin users (%) 15 16 Baseline BMI (kg/m2) 35.9 36.0 Baseline weight (kg) 100.5 100.9 Baseline waist (cm) 113.8 114.1 History of prior cardiovascular disease event (%) 15 14
  • 43. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Assessments  Annual clinic visits  Weight, blood pressure, lipids.  Fitness with maximum treadmill test at baseline and sub-max at years 1 and 4.  Participant’s own physician is responsible for medical care and changes in medications. Adapted from Look AHEAD Research Group Control Clin Trials 2003;24:610-28
  • 44. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Weight Loss at 1 Year Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383 -9 ILI 0 -1 -2 -3 -4 -5 -6 -7 -8 DSE p<0.0001 Changeinweight(%) 8.6% 0.7% ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education
  • 45. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Fitness Change at 1 Year Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383 0 5 10 15 20 25 Meanfitnesschange(%) Unadjusted p<0.001 Adjusted for 1 year weight change p<0.001 5.8 20.9 10.8 15.9 DSE ILI ILIDSE ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education
  • 46. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org 1-Year Changes in Markers of Diabetes Control Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383 Markers of diabetes control ILI DSE p value Hemoglobin A1c (%), Baseline Hemoglobin A1c (%), Year 1 Year 1 – Baseline 7.25 6.61 -0.64 7.29 7.15 -0.14 0.26 <0.001 <0.001 Fasting glucose (mmol/l), Baseline Fasting glucose (mmol/l), Year 1 Year 1 – Baseline 8.4 7.2 -1.2 8.5 8.1 -0.4 0.21 <0.001 <0.001 Diabetes medications (%), Baseline Diabetes medications (%), Year 1 Year 1 – Baseline 86.5 78.6 -7.8 86.5 88.7 2.2 0.93 <0.001 <0.001 ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education
  • 47. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org 1-Year Changes in Markers of Blood Pressure (BP) Control Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383 Markers of blood pressure control ILI DSE p value Systolic BP (mmHg), Baseline Systolic BP (mmHg), Year 1 Year 1 – Baseline 128.2 121.4 -6.8 129.4 126.6 -2.8 0.01 <0.001 <0.001 Diastolic BP (mmHg), Baseline Diastolic BP (mmHg), Year 1 Year 1 – Baseline 69.9 67.0 -3.0 70.4 68.6 -1.8 0.11 <0.001 <0.001 Antihypertensive medications (%), Baseline Antihypertensive medications (%), Year 1 Year 1 – Baseline 75.3 75.2 -0.1 73.7 75.9 2.2 0.23 0.54 0.02 ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education
  • 48. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org 1-Year Changes in Markers of Lipid Control Adapted from Look AHEAD Research Group Diabetes Care 2007;30:1374-1383 Markers of lipid control ILI DSE p value LDL cholesterol (mmol/l), Baseline LDL cholesterol (mmol/l), Year 1 Year 1 – Baseline 2.90 2.77 -0.13 2.91 2.76 -0.15 0.78 0.74 0.49 HDL cholesterol (mmol/l), Baseline HDL cholesterol (mmol/l), Year 1 Year 1 – Baseline 1.12 1.21 0.09 1.13 1.16 0.04 0.80 <0.001 <0.001 Triglycerides (mmol/l), Baseline Triglycerides (mmol/l), Year 1 Year 1 – Baseline 2.06 1.72 -0.34 2.03 1.87 -0.16 0.38 <0.001 <0.001 Lipid-lowering medications (%), Baseline Lipid-lowering medications (%), Year 1 Year 1 – Baseline 49.4 53.0 3.7 48.4 57.8 9.4 0.52 <0.001 <0.001 ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education
  • 50. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org -9 -8 -7 -6 -5 -4 -3 -2 -1 0 0 1 2 3 4 Percent Weight Change from Baseline Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75 Weightchangefrombaseline(%) DSE ILI Repeated measures adjusted for clinic and baseline level P value for average effect across all visits: p<0.0001 Year ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education
  • 51. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Percent Fitness Change from Baseline Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75 Fitnesschangefrombaseline(%) Year -10 0 10 20 30 0 1 2 3 4 DSE ILI ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education Repeated measures adjusted for clinic and baseline level P value for average effect across all visits: p<0.0001
  • 52. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Hemoglobin A1c (HbA1c) Change from Baseline Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75 HbA1cchangefrombaseline(%) Year -0.8 -0.7 -0.6 -0.5 -0.4 -0.3 -0.2 -0.1 0 0 1 2 3 4 DSE ILI ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education Repeated measures adjusted for clinic and baseline level P value for average effect across all visits: p<0.0001
  • 53. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Systolic Blood Pressure Change from Baseline Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75 Systolicbloodpressure changefrombaseline(mmHg) Year -9 -8 -7 -6 -5 -4 -3 -2 -1 0 0 1 2 3 4 DSE ILI ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education Repeated measures adjusted for clinic and baseline level P value for average effect across all visits: p<0.0001
  • 54. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org Use of Any Antihypertensive Drug Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75 Year No baseline use Baseline use DSE N=684 ILI N=661 p value DSE N=1872 ILI N=1895 p value 1 21.9% 16.4% 0.01 89.9% 81.3% <0.001 2 31.9% 24.7% 0.005 90.4% 81.0% <0.001 3 40.3% 33.3% 0.01 91.2% 82.9% <0.001 4 47.2% 43.0% 0.15 92.7% 85.0% <0.001 ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education
  • 55. Source: www.myhealthywaist.orgSource: www.myhealthywaist.org HDL Cholesterol Change from Baseline Adapted from Look AHEAD Research Group Arch Intern Med 2010;170:1566-75 HDLcholesterolchange frombaseline(mg/dl) Year 0 1 2 3 4 5 0 1 2 3 4 DSE ILI ILI: Intensive Lifestyle Intervention DSE: Diabetes Support & Education Repeated measures adjusted for clinic and baseline level P value for average effect across all visits: p<0.0001
  • 56. Source: www.myhealthywaist.org Summary: Four-Year Results of Look AHEAD  Intensive lifestyle intervention has been effective in promoting weight loss and improving fitness through four years of follow-up.  The intensive lifestyle intervention has produced sustained improvements in glycemic control, systolic blood pressure, and HDL cholesterol.
  • 57. Source: www.myhealthywaist.org Where Do We Go from Here?  The DPP/DPPOS ends in 2014 (~2 years).  Major topics of interest include effects of interventions on development of micro- and macrovascular complications of diabetes, physical and mental function, cancer and other problems of aging in these high-risk populations.
  • 58. Source: www.myhealthywaist.org Summary  There is an epidemic of diabetes that is associated with lifestyle changes and obesity.  The metabolic syndrome and impaired glucose tolerance are more prevalent than diabetes.  The metabolic syndrome and impaired glucose tolerance are known risk factors for type 2 diabetes and cardiovascular disease.  Both lifestyle modification and several medications are effective in preventing, delaying and treating type 2 diabetes, but their effectiveness in reducing cardiovascular disease is not yet known.
  • 59. Source: www.myhealthywaist.org How Can We Translate These Results into Practice?  The Why WAIT Program at Joslin. http://www.joslin.org/care/why_wait.html  The CDC programs in collaboration with the YMCA, United Health Care and others.  The Joslin Initiative with Center for Medicare & Medicaid Services and others.  Other community-based initiatives.