Thank you

Contact: heinbel@ccf.org

Terapia en Obesidad: Un abordaje multidisciplinario.

La experiencia en Cleveland Clinic

Barto Burguera MD, PhDProfessor of Medicine Director of Obesity ProgramsEndocrinology and Bariatric InstitutesCleveland Clinic Lerner College of Medicine of CWRUburgueb@ccf.org

Advisory BoardNovo Nordisk

Nestle

Grant / Research SupportNovo Nordisk

Merck

Off Label UsageNONE

DisclosuresB. Burguera

Cleveland Clinic Locations

&

London 2018

Best Hospitals for Diabetes &

Endocrinology

Mayo Clinic

Rochester, MN

#1

#2

#3 Cleveland Clinic

Cleveland, OH

Massachusetts General Hospital

Boston, MA

Honor Roll: Best Hospital

#1 Mayo Clinic

Rochester, MN

#2 Cleveland Clinic

Cleveland, OH

#3 Massachusetts General Hospital

Boston, MA

Learning Objectives

CCF experience with an Interdisciplinary

Life-style Intervention Program:

Nutrition, Physical Activity, Weight

Loss Meds & Surgery

Obesity Primary Problem

Medications

Weight loss improves

comorbidities

Cholesterol 10%

LDL 10%

HDL 8%

Triglycerides 30%

Jung RT: Obesity as a disease: Br Med Bull: 1997:53:307-321

Benefits of moderate weight loss (7-10%)

Mortality 20-25 %

DM related death 30-40 %

Death by CVD 40-50%

Systolic and dyastolic BP 10 mm Hg

Diabetes Risk >50%

Fasting BG 30-50%

HbA1c 15%

5,000 employees with BMI >40(5,000 family members)

Obesity iceberg:US Population: 300 million

Morbid obesity: 15 mil

Obesity: 85 mil

Overweight: 100 mil

Normal weight: 100 mil

A.M.A. Recognizes Obesity as a DiseaseJUNE 18, 2013

• Focus more attention on obesity

• Reduce the stigma: “Result of eating too much or exercising too little”

• Induce physicians to pay more attention to the condition:

–Help improve reimbursement for obesity counselling, drugs and surgery

–Medicare Part D (prescription drug benefit): will not pay for drugs to treat weight

loss, alopecia and ED

• CCF: Prevalence of obesity and its related comorbidities among patients being actively managed.

• Frequency of a formal diagnosis of obesity, via ICD-9 documentation among patients with a BMI > 30.

• Methods: The electronic health record system at Cleveland Clinic was used to create a cross-sectional summary of non-

pregnant patients, 20 years of age or older, as of July 1, 2015.

• Patients were required to have been seen by a primary care physician at least 3 times prior to July 01, 2015, and at least one of these visits

must have occurred within the immediate 18 months preceding July 01, 2015.

• The cohort was characterized and stratified by BMI category:

– Lean: <25

– Obesity 25-30

– 30-35

– 35-40

– >40)

Do we recognize Obesity as a disease?

Burguera et al. TOS 2016

• Results: As of July 1, 2015:

– 324,199 active patients were identified.

– The median age was 52 years and the majority were female (54%).

• Overweight 121,287 (37.4%)

• Obese level 1 (BMI 30-34.9) 75,199 (23.2%)

• 255,775 (78.9 %)

• Obese level 2 (BMI 35-39.9) 34,152 (10.5%)

• Obese level 3 (BMI >40) 25,137 (7.8%)

Burguera et al. TOS 2016

• Obese level 3 (BMI >40) 25,137 (7.8%)

Documentation of an ICD9 code for obesity:

• Of all the patients with a

• BMI > 30 (N = 134,488), only 48%

• BMI > 40 (N = 25,137), only 77%

had a diagnosis of obesity

BARRIERS TO OBESITY therapy:

1. Obesity thought not to be a real disease

1. Self inflicted

2. Controlling weight requires continues effort

Knowledge not enough to control the disease

BMI: 33BMI: 29

BMI: 36BMI: 34

BMI: 32

BMI: 28

An intensive life-style program offered to patients with morbid obesity, who are not candidates or not

interested in undergoing bariatric surgery.

In the context of Shared Medical Appointments.

Team: Endocrinologist, Exercise Physiology, Psychologist, Nutritionist, Nursing, Surgeon

Bariatric & Endocrinology and Cardiology Metabolic Institutes

Objective: To develop an optimal medical weight loss program to offer patients with BMI > 35 non-

surgical candidates

Program included in CCF Health Plan

It is our goal to accomplish a 10-15% weight after 12 months of intervention and weight loss

maintenance after 30 months

Interdisciplinary Life style

Intervention Program

The Look AHEAD study was the first randomized controlled trial to examine whether

weight loss, combined with increased physical activity, reduced cardiovascular morbidity

and mortality in overweight and obese individuals with type 2 DM.

Tratamiento medico obesidad morbida:meds,terapia conductual, nutricion y actividad

Objectives To evaluate the impact of:

An intensive lifestyle intervention program in patients with MO, that included: Health education in areas of nutrition and physical activity & group therapy

Compared to:

Medical group that received traditional treatment

Surgical group made up of patients with morbid obesity that have undergone bariatric surgery as treatment for their obesity

This study was carried out for a period of 24 months Plus 6 months follow up

Estudio TRAMOMTANA. EudraCT 2009-

013737-24

Tur J, et al.. Endocrinol Nutr. 2011

Tur J. et al. Clin Endo. 2013

Burguera B. al. International Journal of Endocrinology. 2015

Recruitment

Estudio TRAMOMTANA. Nº

EudraCT 2009-013737-24

Morbid obesity

IMC>40 Kg./m2

N = 143

Surgical

group

N = 37

Medical group

N =106

Intensive

treatment

N = 60

Tradicional

medical treatment

N = 46

Randomization

Participants and Interventions

• Physical activity:

– Evaluation and personalized exerciseadvice.

• Nutrition:

– Evaluation and nutritionalcounseling. Mediterraneandiet (without caloricrestricition).

Estudio TRAMOMTANA. EudraCT 2009-

013737-24

Inform and motivateClose follow up

PRIMARY ENDPOINT: two years data

PRIMARY ENDPOINT two years data

PRIMARY ENDPOINT two years data

Interdisciplinary Life style

Intervention Program

To providing our patients with the necessary therapeutic tools, which will allow them to:

• Become more accountable

• Slowly obtain control over their weight

• Improve at the same time their general health

Patients have visits every 4 weeks

Team; Nutrition; Endocrine; Psychologist; Exercise Physiologist and surgeon

Visits are in the context of shared medical appointment

Duration: 3 years

APPETITE

REGULATION

ADIPOSTAT: SET POINT

DIET PH ACTIVITY STRESS SLEEP GI

FLORA

LIGHTFAT

signals

APPETITE

REGULATION

VITAMINS

MEDICATIONS

BARIATRIC SURGERYADIPOSTAT: SET POINT

• Mediterranean Diet: Focused around plant based foods(fresh fruits, vegetables, whole grains, and beans/lentils) Encourages heart healthy fats such as nuts, seeds, olive oil, avocado Limited red meat encouraging more fish, seafood and poultry Low-fat dairy Allows flexibility with food choices Typical average weight loss of 3-5 pounds per month while enjoying a variety of healthy food

choices•

• Meal Replacement Plan:

Uses pre-packaged shakes or bars that you can purchase from your local store in place of 2 meals per day paired with a piece of fruit or vegetable, and 1 balanced meal per day. You are additionally given 1-2 healthy snacks per day as desired.

Easy to start and very structured with limited food preparation and cooking Controls calories consistently each day to increase the weight loss process Average weight loss of 6-12 pounds per month

•

• Protein Sparing Modified Fast: Very low carb diet focused on lean meat, low carb vegetables, and limited fats. Promotes increased weight loss through a low carb diet by putting the body into a “ketosis” or

rapid weight loss mode Strict program where monthly labs work is required Typical average weight loss is 8-15 pounds per month•

1. Nutrition. Patients can select one of three dietary programs:

2.- Encourage an improvement on their life style

Regular physical activity

Personalized program:

Walking

Upper body exercises

Swimming

Integrated in daily activities

Short term goal

Plan a head

• We pay special attention to appetite control. It is very difficult to help people to lose weight without reducing their appetite.

• These medications are useful to reduce the patient’s appetite set point in the brain.

• FDA approved.

34

• 3. - Appetite control: weight loss medications.

4. - Healthy sleeping habits

• Lack of sleep is associated to increased appetite

• Referrals to sleep clinic to r/o restless leg syndrome, obstructive sleep apnea, or other sleeping disorders

• Many patients are not aware of the circumstance

• Increases the risk of suffering a heart attack, a stroke, hypertension and hypogonadism

35

.

5. - Try to improve the level of stress in our patients’ life

• Collaborate with our Psychology colleagues at the Bariatric Institute, to assist us with the behavior modification component

• The prevalence of eating disorders, anxiety, depression and other psychiatric disorders is significant in the patients with morbid obesity

• Many of these patients may benefit from antidepressant therapy

• Psychotherapy in the context of SMAs, is also very helpful to address issues related to food addiction, bulimia and binge eating disorders

We provide tools Accountability

1.- Nutrition: quality, quantity, portion sizes, drinks …

2.- Physical Activity: personalized exercise programs.

GOALS: short and midterm

3.- Appetite control: weight loss medications

4.- Sleep patterns. R/o OSA

5.- Stress. Depression. Anxiety

Bariatric surgery, if a medical approach is not successful

Emphasis on :

Phases of Obesity Treatment

Phase I(Weight Loss)

3-6 months

Phase II(Weight-Loss Maintenance)

Indefinitely

When you stop treatment,

the disease comes back!

Weig

ht

120114

92

59

3933

26

13

47 43

26

11

0

20

40

60

80

100

120

140

Baseline 3 months 6 months 12 Months

Number of Participants in Each Program

MEDIT MR PSMF

Total: 206 patientsMediterranean diet: 120 patientsMeal replacement: 39 patientsProtein sparing modified fast: 47 patients

2,6%

5.9%5.4%

6.2%

8.9%

10.8%

6.7%

8.6%9.5%

0

2

4

6

8

10

12

3 months 6 months 12 Months

Average Percent Weight Loss Over TimeBy Diet

MEDIT MR PSMF

2,6%

5.9%5.4%

6.2%

8.9%

10.8%

6.7%

8.6%9.5%

0

2

4

6

8

10

12

3 months 6 months 12 Months

Average Percent Weight Loss Over TimeBy Diet

MEDIT MR PSMF

2,6%

5.9%5.4%

6.2%

8.9%

10.8%

6.7%

8.6%9.5%

0

2

4

6

8

10

12

3 months 6 months 12 Months

Average Percent Weight Loss Over TimeBy Diet

MEDIT MR PSMF

0

10

20

30

40

50

Weight Gain 1-4% 5-9% 10-14% >=15%

Percentage of people by category of weight changes

and diet at 3 Months(N=190)

MEDIT MR PSMF

0

5

10

15

20

25

30

35

40

45

Weight Gain 1-4% 5-9% 10-14% >=15%

Percentage of people by category of weight changes

and diet at 6 Months

MEDIT MR PSMF

0

5

10

15

20

25

30

35

40

45

Weight Gain 1-4% 5-9% 10-14% >=15%

Percentage of people by category of weight changes

and diet at 12 Months

MEDIT MR PSMF

37

38

39

40

41

42

43

44

45

BASELINE 3 MONTHS 6 MONTHS 12 MONTHS

Change of BMI over time

MEDIT MR PSMF

0

10

20

30

40

50

60

70

80

90

Basline 3 Months 6 Months 12 Months

Drop out Rate

METI MR PSMF

• Interdisciplinary lifestyle intervention

• Shared medical appointments x 3 years

• 520 patients, approximately 20 % are Cleveland Clinic employees

• Every 4 weeks (dietitian and physician visits)

• Group consists of 5-8 patients.

• Retention~ 50% of patients who have started the program in MED diet

• Appetite supp. Meds: 80%

• Patients referred to bariatric surgery: 35

• Value of the support that they received from the other participants

Interdisciplinary Life style

Intervention Program

Telemedicine in the

context of SMAs

Telemedicine in the

context of SMAs

Team effort: EMI, BMI and Preventive Cardiology

• Kelly Nocero RN

• Dawn Noe RD

• Hillory Sullivan RD

• Erin Daigle. NP.

• Ninoska Peterson PhD. Psychology BMI

• Leslie Heinberg PhD Psychology. BMI

• Dr. Gordon Blackburn. Cardiology. Exercise Phys.

• Beth Abood RN

• Julia Serrano MA

• Dawn Noe RD

• Anita Hollis

• Toni Blair

• Mavis Delanie

• Kathryn Corte RD

• Shannon Knapp RD

• Ula Abed Alwahab MD

• Beverly Skala

• Kelly Shibuya MD

• Ron Gambino RN

• Elena Baruch MD

• Barto Burguera MD, PhD

CCF WEIGHT LOSS PROGRAM