Reducing Cardiovascular Risk in Patients With Diabetes

Robert J Bulgarelli DO FACC CMADirector Integrative Cardiology - MLHS

CMO – the Habit Change Company

The CholesterolAnd Dietary Fat Obsession

United States: 1979–1998 mortality.American Heart Association. 2001 Heart and Stroke Statistical Update. 2000.

79 9781 83 85 87 89 91 93 95

400

0

420

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520

Dea

ths

(in

th

ou

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Men Women

Years

CVD Deaths: 1979–1998

98

NCEP I NCEP II NCEP III

Metabolic Syndrome

• Components:– Obesity

– Insulin Resistance

– Dyslipidemia

– Hypertension

Metabolic Syndrome

• 34% of U.S. adults

Diagnosis• 3 or more of the following

– Hypertension > 130/85– Waist > 40” men, >35” women– HDL < 40 for men, < 50 in

women– Triglycerides > 150– Fasting glucose > 110

Cardiovascular Mortality

2.2

12

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2

4

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12

14

No MS MS

Inci

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Diabetes Care 2001;24:683 Diabetes Care 2001;24:683

p < 0.001p < 0.001

Patterns of Body Fat Distribution

Abdominal(android)

Lower body(gynoid)

1998

Obesity TrendsAmong U.S. Adults(*BMI 30, or about 30 lbs. overweight for 5’4” person)

2007

1990

No Data <10% 10%–14% 15%–19% 20%–24% 25%–29% ≥30%

• 1990 • 10 States had a prevalence of obesity less than 10%• 0 States had prevalence equal to or greater than 15%.

• 1998• 0 States had prevalence less than 10%• 7 States had a prevalence of obesity between 20-24%• 0 States had prevalence equal to or greater than 25%.

• 2007• 1 State (Colorado) had a prevalence less than 20%• 30 States had a prevalence equal to or greater than 25%

• 3 States (Alabama, Mississippi and Tennessee) had a prevalence of obesity equal to or greater than 30%.

• 1990 • 10 States had a prevalence of obesity less than 10%• 0 States had prevalence equal to or greater than 15%.

• 1998• 0 States had prevalence less than 10%• 7 States had a prevalence of obesity between 20-24%• 0 States had prevalence equal to or greater than 25%.

• 2007• 1 State (Colorado) had a prevalence less than 20%• 30 States had a prevalence equal to or greater than 25%

• 3 States (Alabama, Mississippi and Tennessee) had a prevalence of obesity equal to or greater than 30%.

Obesity TrendsAmong U.S. Adults(*BMI 30, or about 30 lbs. overweight for 5’4” person)

Recent Trends

• Type 2 DM in Children and Adolescents• Obesity, low level of physical activity, as well as

exposure to diabetes in utero, may be major contributors

• Generally between 10 and 19 years old, obese, have a strong family history for type 2 diabetes, and have insulin resistance and have poor glycemic control (A1C = 10% - 12%).

• CDC estimates that among new cases of childhood diabetes, the proportion of those with type 2 diabetes ranges between 8 percent and 43 percent.

Diet, Lifestyle, and Risk of Type 2 Diabetes Mellitus in Women

• Nurses’ Health Study (84,941) female nurses followed for 18 years

• 3300 new cases of type 2 diabetes mellitus

• Lack of exercise, poor diet also major risk factors

• BMI most important risk factor– BMI > 35 38.8 RR

– BMI 30-35 20.1 RR

Hu et al. NEJM 2001;345:790Hu et al. NEJM 2001;345:790

+ = moderately increased compared with nondiabetic population++ = markedly increased compared with nondiabetic population – = not different compared with nondiabetic population

Prevalence CAD Risk Factors in Type 1 vs. Type

Type 1Type 1Dyslipidemia Hypertriglyceridemia Low HDL Small, dense LDL Increased apo BHypertensionHyperinsulinemia/insulin resistanceCentral obesityFamily history of atherosclerosisCigarette smoking

Adapted from Chait A, Bierman EL. In: Joslin’s Diabetes Mellitus. Philadelphia: Lea & Febiger, 1994:648-664.

Type 2Type 2Risk FactorRisk Factor

+–––+––––

+++++++++++++++–

Risk Factors for IHD*

*Data from the Quebec Heart Study.Adapted from Lamarche B et al. JAMA. 1998;279:1955–1961.

Odds Ratio P

Elevated fasting insulin 5.5 .001

Elevated triglycerides 3.5 .002

Elevated ApoB 2.7 .01

Small dense LDL 2.5 .01

Elevated LDL-C 2.4 .03

Reduced HDL-C 1.6 .15

Glucose(mg/dL)

50 –

100 –

150 –

200 –

250 –

300 –

350 –

Fasting Glucose

Post meal Glucose

0 –

50 –

100 –

150 –

200 –

250 –

-10 -5 0 5 10 15 20 25 30

Years of Diabetes

*IFG = impaired fasting glucose.

©2000 International Diabetes Center, Minneapolis, Minnesota. Used with permission.

RelativeFunction

(%)

Insulin Resistance

-Cell Failure

Obesity IFG* DiabetesUncontrolledHyperglycemia

Natural History of Type 2 Diabetes

Over 90% of Type 2’s are Insulin Resistant

Hypertension

Type 2 Diabetes

DisorderedFibrinolysis

ComplexDyslipidemia TG, sdLDL

HDL

EndothelialDysfunction Systemic

Inflammation

Atherosclerosis

VisceralObesity

Adapted from the Consensus Development Conference of the American Diabetes Association. Diabetes Care. 1998;21(2):310-314.Haffner SM, et al. Diabetes Care. 1999;22(4):562-568.Pradhan AD, et al. JAMA. 2001;286(3):327-334.

The Importance of Targeting Insulin Resistance

Insulin Resistance

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CHF/CAD

Dea

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(%)

Geiss LS et al. In: Diabetes in America. 2nd ed. 1995; ch 11.

Mortality in Patients With DiabetesCauses of Death

Diabetes Cancer Stroke Infection Other

Incidence of CHD* Events in Patients With and Without Diabetes

*Coronary heart disease

Haffner SM et al. N Engl J Med. 1998;339:229–234.

Events per 100 Person-yr

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18.8

Non diabetics with no prior MI

Non diabetics with prior MI

Diabetics with no prior MI

Diabetics with prior MI

n=69 n=890 n=169

0.5 3.0 3.2 7.8

3.5

45.0

20.2P<.001

P<.001

Adapted from the United Kingdom Prospective Diabetes Study. Stratton IM, et al. BMJ. 2000;321(7258):405-412.

The Need for Tight BG Control

According to the United Kingdom Prospective Diabetes Study (UKPDS) 35, every 1% increase in A1c resulted in:

Increase in risk of

microvascularcomplications

Increase in any

diabetes- related

endpoint

Increase in risk of MI

Increase in risk of

stroke

21%21%14%14% 12%12%

37%37%

Diabetes Control and Complications Trial (DCCT)

• 1983 – 1993

• 11,441 pts. / 29 centers in US and Canada

• DM > 1yr and < 15yr ; no eye disease

• Standard care vs intensive management• Intensive insulin therapy• Diet and exercise • Behavioral therapy

• Carotid intima-media thickness

Diabetes Control and Complications Trial (DCCT)

• Results• 76% reduction in eye disease• 6% reduction in neuropathy• 54% reductions in urine albumin secretion• 50% reduction in nephropathy• Overall improvements in BP, Hgb A1c, HDL

and LDL

Treatment of CAD Risk in DM: Are We Doing a Good Job?

George PB et al. Am Heart J. 2001;142:857–863.

Suboptimal

Optimal

Do We Reach Treatment Goals?

100% 80% 60% 40% 20% 0% 10% 40% 60% 80% 100%

HbA1c <7.0

HDL >45 (men)

HDL >55(women)

LDL <100

Triglycerides <200

BP <130/85

BMI <25

Prospective observational study of 235 treated (oral or insulin) CAD patients with Diabetes

Treatment of CAD Risk in DM:Are We Doing a Good Job?

George PB et al. Am Heart J. 2001;142:857–863.

Do We Prescribe Optimal Cardiovascular Drug Therapy?

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100% Patients Treated by Medication

Lipid-loweringdrugs

-Blockers ACEinhibitors

Aspirin

Prospective observational study of 235 treated (oral or insulin) CAD patients with Diabetes

60% Type 2’s Not At ADA HgbA1c Goal <6%

GOAL Survey

% OfSubjectsN = 371

40.3%>8%

59.4%>7%

26.5%

19.1%

40.6%

13.8%

HgbA1c

Adults aged 20-74 y with previously diagnosed diabetes who participated in the interview and examination components of the National Health Examination Survey (NHANES), 1999-2000.Saydah et al. Diabetes. 2003;52(suppl 1):A228 (Abstract 979-P).

United Kingdom Prospective Diabetes Study (UKPDS)

*Conventional=diet therapy.

UK Prospective Diabetes Study (UKPDS 34) Group. Lancet. 1998;352:854-865.

Traditional Therapies Do Not Maintain A1c Control Over Time

Med

ian

A1c

(%

)

Conventional*Insulin

Glibenclamide (glyburide)Metformin

0 306

7

8

9

6 9 10

Time from Randomization (Years)

ADA goal

We have a lot of catching up to do!

20102010 NowNow

Primary Prevention: Status and 2010 Goals

NCEP. Adult Treatment Panel III Report. 2001.

Moderate physical activity

Vegetable intake of >3 servings

Saturated fat <10% of calories

Primary Prevention: Status and 2010 Goals

Fruit >2 servings/d

Smoking cessation

Healthy weight

20102010 NowNow

NCEP. Adult Treatment Panel III Report. 2001.

Hard enough to get people to take their meds!

Same old thing Over and Over…

Whole new way of looking at things!

Lifestyle ManagementThe 8 Essential Habit Areas

• Nutrition / Supplements

• Physical Fitness

• Affiliation

• Resilience (Stress Management)

• Spirituality

• Sleep

• Simplicity

• New Learning (Neuroplasticity)

Diet

Healthy Eating

Early weight loss!

Your food shall be your remedy……

Hypocrites

Diet and Heart Disease

• Dietary intervention trials using morbidity / mortality endpoints• 30 – 70% reduction events and death

• Dietary intervention trials using angiographic endpoints• Decreased lesion progression and regression

• Brousseau etal Current Atherosclerosis Repots 2000• Diet and CAD: Clinical Trials

Atkins?

Ornish?

What do our kids think?

Healthy Eatingand Heart Disease

• Good Fats / Mediterranean• Lyon Diet Study

• 2nd prevention trial• Mediterranean vs. SAD • 70% reduction in recurrent coronary events /

cardiac death post MI!• Maintained out to 4 years!

• Lorgeril etal Lancet 1994 ;343: 1454-1459

Mediterranean Diet

• Fiber

• Vitamin E

• Omega-3 fatty acids

• Folic Acid

• Monounsaturated fat

• Phytochemicals and antioxidants

• Calcium, magnesium, selenium

Healthy Eating and Diabetes

• The use of low-glycaemic index diets in diabetes control

– British Journal of Nutrition Cambridge University Press Copyright © The Authors 2010D. E. Thomasa1 c1 and E. J. Elliotta1a2a3 a1 Centre for Evidence Based Paediatrics Gastroenterology and Nutrition (CEBPGAN), Sydney Medical School, The University of Sydney, c/o Research Building, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145, Australia

– Meta-analysis – 12 RCT’s (612 patients Type 1 & 2)• Low Glycemic Index vs. High Glycemic Index Diet

(Controvesial)– Statistically significant improvements in HgbA1c

» Mean decrease of 0.4 % HbA1c, 95 % CI − 0.7, − 0.20 P = 0·001

Exercise

Physical Fitness

“Those who think they have no time for bodily exercise will sooner or later have to

find time for illness.”

Edward Stanley (1827-1893)

The Conduct of Life

Move it or lose it!

…but really move it!

Physical Fitness and Heart Disease

• Exercise• Many clinical trials:

• 40 – 50 % reduction in events compared with meds alone

• Improved Q.O.L.

Physical Fitness and Heart Disease

• A META-ANALYSIS OF PHYSICAL ACTIVITY IN THE PREVENTION OF CORONARY HEART DISEASE

– American Journal of Epidemiology Vol. 132, No. 4: 612-628 Copyright © 1990 by The Johns Hopkins University School of Hygiene and Public Health JESSE A. BERLIN1,2, and GRAHAM A. COLDITZ1,31Technology Assessment Group, Harvard School of Public Health Boston, MA2University of Pennsylvania School of Medicine, Section of General Internal Medicine, Clinical Epidemiology Unit Philadelphia, PA3Channing Laboratory, Harvard Medical School Boston, MA

– Relative risk of death from coronary heart disease:• 1.9 (95% confidence interval 1.6–2.2) • Sedentary compared with Active

Physical Fitness and Heart Disease

• Exercise-based rehabilitation for patients with coronary heart disease: meta-analysis

– American Journal of Medicine Volume 116, Issue 10, Pages 682-692 (15 May 2004) Rod S Taylor, MSc; etal

– 48 trials with a total of 8940 patients• Reduced All-Cause mortality (odds ratio [OR] = 0.80; 95%

confidence interval [CI]: 0.68 to 0.93)• Reduced Cardiac mortality (OR = 0.74; 95% CI: 0.61 to 0.96)• Reduced Total cholesterol (weighted mean difference, –0.37 mmol/L [–

14.3 mg/dL]; 95% CI: –0.63 to –0.11 mmol/L [–24.3 to –4.2 mg/dL

• Reduced Triglycerides (weighted mean difference, –0.23 mmol/L [–20.4 mg/dL]; 95% CI: –0.39 to –0.07 mmol/L [–34.5 to –6.2 mg/dL]

• Reduced Systolic blood pressure (weighted mean difference, –3.2 mm Hg; 95% CI: –5.4 to –0.9 mm Hg)

• Reduced rates of self-reported smoking (OR = 0.64; 95% CI: 0.50 to 0.83)

Physical Fitness and Diabetes

• Resistance Training in the Treatment of the Metabolic Syndrome: A Meta-Analysis

– Sports Medicine, Volume 40, Number 5, 1 May 2010 , pp. 397-415(19) Strasser, Barbara1; Siebert, Uwe; Schobersberger, Wolfgang1 University for Health Sciences, Medical Informatics and Technology, Institute for Sport Medicine, Alpine Medicine and Health Tourism, Hall i. T., Austria

– Metabolic consequences of reduced muscle mass, as a result of normal aging or decreased physical activity, lead to a high prevalence of metabolic disorders

• Meta-Analysis – 13 RCT’s – Effect of Resistance Training– HbA1c by 0.48% (95% CI −0.76, −0.21; p = 0.0005)

– Fat mass by 2.33 kg (95% CI −4.71, 0.04; p = 0.05) – Systolic blood pressure by 6.19 mmHg (95% CI 1.00, 11.38; p = 0.02)– No statistically significant effect of RT on:

» total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride and diastolic blood pressure

Stay Active

Exercise Weight and Heart Health

• 22,000 Men / 8 years• % body fat and exercise

treadmill testing• Thin / Fit = 1/3 cardiac

related death c/w Thin / Un-Fit

• Fit / Obese men had lower death rates than Unfit / Thin men!

•Lee et al, Am J of Clin Nutrition 1999; 69: 373

Fitness / Fatness and Heart Health

Lean<16.7%

Rel

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Body Fat Category (% Weight as Fat)Lee et al. Am J Clin Nutr 1999;69:373.

Normal16.7%-24.9%

Obese>25%

Aerobically fit

Unfit

Pedometers: Taking the first steps!

• Great motivational tool• Low upfront cost• Healthcare cost savings• Preliminary outcome data particularly in

diabetics• Problems:

– No standards yet (10,000 steps/day)– First Step Program – US and Canada

• Tudor-Locke Dept. Exercise and Wellness ASU• President’s Council on Physical Fitness and Sports 2001

“As a man thinketh in his heart, so shall his life be

made”

Osler

You are what you…..believe!

Unresolved Anger / Unresolved Anger / Grief Grief RelationshipsRelationships

Images / BeliefsImages / Beliefs

Generalized Stress and Generalized Stress and AnxietyAnxiety

ValuesValues

Where does Stress come from?

• “We often get so caught up in the drama of our lives that we forget that we are the ones who created the drama in the first place”

• Matt Flickstein Journey To The Center

Is it you or them?

Dis-Stress

Dis-Ease

Disease

Stress and Heart Disease

• Psycho-social factors, particularly depression, negatively predict:– Adherence and outcomes of Cardiac Rehab– Adherence to Smoking cessation programs– Adherence to weight management programs

• Glazer et al, J of CardioPulm Rehab 2002; 22: 40-46 Psychological predictors of adherence and outcomes among patients in cardiac rehab

Stress Management and Heart Disease

• Psycho-social interventions designed to modify these factors have been shown in large meta-analyses to reduce fatal and non fatal events by 30 – 50%

• Dusseldorp et al, Health Psych 1999; 18:506-519

• Sustained effectiveness • Compared to diet / exercise (temporary)

• Luskin et al. Alternative Therapies May 1998 A review of mind body approaches to CHD

Dis-stress and Diabetes

• In people with diabetes, dis-stress alters blood glucose levels  – Direct:

• Stress-mediated production of:– Cortisol, Norepinephrine, Beta endorphin, Glucagon, and

Growth hormone

– Indirect: • People when under stress often make poor health

choices– Less physical activity– Poor meal choices– Check BG less frequently

Stress Management and Diabetes

• Stress management improves long-term glycemic control in type 2 diabetes

– Surwit RS, Diabetes Care. 2002 Jan;25(1):30-4

• 108 patients with type 2 diabetes – Five-session group diabetes education program with or without stress

management training.

• HbA(1c) tests, questionnaires assessing perceived stress, anxiety, and psychological health were administered at regular intervals to evaluate treatment effects

• Stress management training was associated with a small (0.5%) but significant reduction in HbA(1c)

• CONCLUSIONS: The current results indicate that a cost-effective, group stress management program in a "real-world" setting can result in clinically significant benefits for patients with type 2 diabetes

Stress Management and Children with Diabetes• Stress Management Training for Adolescents with

Diabetes– Journal of Pediatric Psychology 18(1) pp. 29-45, 1993

• Ronald H. Boardway Wayne State University School of Medicine

• Effects of stress management training (SMT) for

adolescents with diabetes• 9-month controlled treatment-outcome study

– Diabetes-specific stress decreased significantly for patients in the SMT group

Group Support

• Social connection decreases stress and depression• Emotional quality > Structural quality

• Perceived low social support strongly associated with:– anger – depression

• 149 men and women with angina

• Questioned pre-catheterization regarding feeling loved and supported

• Those with the greatest perception of love and support had the least amount of CAD

• Seeman, TE and SL Syme, Psychosomatic Medicine,

1987;49(4):341-54

Group Support and CAD

Medicine and Faith in 1910: Immeasurable?

“Nothing in life is more wonderful than faith -- the one great moving force which we can neither weigh in the balance nor test in the crucible…mysterious, indefinable, known only by its effects, faith pours out an unfailing stream of energy while abating neither jot nor tittle of its potency.”Sir William Osler (1910). “The faith that heals,” British Medical

Journal, 1:1470-72.

Ornish

• Pilot Project• 10 patients with severe CAD• 30 day residential study• 62% increase in time on treadmill• 90% reduction in anginal frequency• improvements in myocardial perfusion as measured

by exercise thallium scintigraphy

• Ornish, Gotto, Miller et al. Clin. Res.1979, 27:720A

The Lifestyle Heart TrialOne-Year Data

• 48 patients with severe coronary artery disease• Outpatient 1 year intervention extended to 4

– Percent diameter lesion stenosis• improved in the experimental group and worsened in the control

group (p = 0.001).• Ornish, Brown, Scherwitz et al, Lancet. 1990, 336: 129-133

Ornish – 1 year Data Analysis

Treatment

• 37% decrease – LDL• 91% decrease - Angina• 82% decrease - Stenosis

Control

• LDL – Increase or same• 165% - Increase Angina• 53% - Progression

Ornish - Five-Year Data

• Continued angiographic improvement in the experimental group and continued progression in the control group

• PET scans showed improvement in myocardial perfusion– 99% of patients stopped or reversed the progression of disease

as measured by PET scan

• Changes in stenosis associated with – adherence to the intervention – Improved Lipid Profile

• The risk ratio for total cardiac events was 2.5 times greater in the control group than in the experimental group

• Ornish D, Scherwitz L, Billings J, et al. JAMA. 1998;280:2001-2007.• Gould, Ornish, Scherwitz et al. JAMA. 1995, 274:894-901

Finnish Diabetes Prevention Study

• Design

– 522 middle-aged overweight (BMI 31)

– 172 men and 350 women

– Mean duration 3.2 years

• Intervention Group: Individualized counseling

– Reducing weight, total intake of fat and saturated fat

– Increasing uptake of fiber, physical activity

Tuomilehto J et al. N Engl J Med 2001;344:1343-1350.

Finnish Diabetes Prevention Study

Goals Goals

InterventioInterventionn

ControlControlss

P valueP value% of subjects% of subjects

Wt reduction Wt reduction >5%>5% 4343 1313 0.0010.001

Fat intake < Fat intake < 30% energy30% energy 4747 2626 0.0010.001

Sat fat Sat fat <10% energy<10% energy 2626 1111 0.0010.001

Fiber Fiber >15 g/1000 kcal>15 g/1000 kcal 2525 1212 0.0010.001

Exercise > 4 Exercise > 4 hr/wkhr/wk 8686 7171 0.0010.001

Tuomilehto J et al. N Engl J Med 2001;344:1343-1350.

Finnish Diabetes Prevention Study

Tuomilehto J et al. N Engl J Med 2001;344:1343-1350

InterventionIntervention ControlControl

After 4 After 4

years — years —

risk of risk of

diabetediabete

s s

reduced reduced

by by

58%58%

11%11%

23%23%

(6–15 CI)(6–15 CI) (17–29 CI)(17–29 CI)

% with Diabetes% with Diabetes

Diabetes Prevention Program

• 3,234 men and women with impaired glucose tolerance (fasting plasma glucose 95–125 mg/dL and 2-hr postload glucose 140–199 mg/dL) and BMI 24

• 45% from minority groups with increased prevalence of type 2 diabetes: African Americans, Hispanic Americans, Asian Americans, and American Indians

• 27 centers nationwide• Randomization to lifestyle changes to include at least 7%

weight loss and exercise 150 min/wk, metformin 850 mg b.i.d., or placebo

• Primary endpoint: development of diabetes• Follow-up: designed for 3.5–5 years, but discontinued 1 year

early because of conclusive results (mean 2.8 years)

Diabetes Prevention Program. Diabetes Prevention Program. Diabetes CareDiabetes Care 1999;22:623-634. 1999;22:623-634.Diabetes Prevention Program. Diabetes Prevention Program. Diabetes CareDiabetes Care 2000;23:1619-1629. 2000;23:1619-1629.

Diabetes Prevention Program

LifestyleLifestyle

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Trial was discontinued 1 year early because of clear Trial was discontinued 1 year early because of clear resultsresults

PlaceboPlaceboMetforminMetformin

58% reduction58% reduction58% reduction58% reduction

1414

31% reduction31% reduction31% reduction31% reduction

5-7% reduction in body weight; exercise 30 min/d5-7% reduction in body weight; exercise 30 min/d

2222 2929

Knowler WC, et al. Knowler WC, et al. N Engl J MedN Engl J Med 2002;346:393-403. 2002;346:393-403.

Diabetes Prevention Program

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Knowler WC, et al. Knowler WC, et al. N Engl J MedN Engl J Med 2002;346:393-403. 2002;346:393-403.©©2002 Massachusetts Medical Society.2002 Massachusetts Medical Society.

00

p<0.001p<0.001

11 22 33 44

PlaceboPlacebo

LifestyleLifestyle

MetforminMetformin

Ready to take some new steps?

What’s at Risk?What’s at Risk?

What’s at Risk?What’s at Risk?

When you look in the mirror what do you see?

The Bottom Line!

Only the thoughts of which you are

unaware can control you!

You can’t stop the waves, but you can learn to surf John Kabat-Zinn Wherever you go, there you are

The Wisdom of Children!