Sanjiv Shah Diabetologist & Endocrinologist Diabetes Action Centre Mumbai, India

Management of pre-diabetes: lifestyle

Sanjiv Shah Diabetes Action Centre

Mumbai, India

Management of prediabetes: Lifestyle

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Learning objectives of the presentation

Highlight the importance of pre-diabetes.

Understand why Lifestyle modification is the best

modality of treatment to prevent diabetes.

Review of most relevant literature on LSI.

Long term cardiac benefits with lifestyle modification

How best to implement lifestyle modification in changing times.

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Epidemiology of Pre-diabetes

• According to the Diabetes Atlas of 2013, IDF estimated 65.1 million diabetic people in India, a number expected to rise.

• Overall prevalence of IGT in India is increasing, reaching 8-16%, higher than prevalence of diabetes itself, and the conversion rate from, IGT to diabetes is 35%.

• The age of onset of Diabetes in Indians is getting younger. • More than 5 % of diabetics are less than 30 years of age. • Therefore, IGT management in India is essential. Sicree R, Shaw J, Zimmet P. Diabetes and impaired glucose tolerance. Gan D, editor. Diabetes Atlas. International Diabetes Federation. Belgium: International Diabetes Federation; 2009.

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PREDIABETES ALGORITHM IFG (100-125),IGT (140-199) METABOLIC SYNDORME (NCEP 2005)

PRIMARY PREVENTION: Evidence-based

• Chinese study : Lifestyle modification

• Finnish study : Lifestyle modification

• DPP / IDPP : Lifestyle vs Metformin

• STOP-NIDDM : Acarbose

• DREAM : Rosiglitazone

• XENDOS : Orlistat

• TRIPOD : Pioglitazone

• NAVIGATOR : Nateglinide

• ORIGIN : Glargine insulin

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Long term follow-up of Da Qing Study

A 20-year follow-up of the Da Qing study determined that lifestyle intervention resulted in a 51% lower incidence of diabetes during active intervention and 43% lower incidence over 20 years, which translated to 3.6 fewer years with diabetes.

Lancet 2008;371:1783-1789.

Over a 6-year period, there was an approximate 2-fold reduction in the incidence of diabetes in individuals practising lifestyle interventions: 7.9 in those receiving lifestyle interventions compared with 14.1 per 100 person years in the control group.

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the Finnish Diabetes Prevention Study

• 522 overweight (BMI ≥25 kg/m2) men and women aged 40 to 65 years with IGT, follow-up for 4 years

• the cumulative incidence of diabetes was - 11% in the lifestyle intervention group, - 23% in the control group. • To prevent 1 case of diabetes, 22 subjects with IGT must be treated with lifestyle intervention for 1 year, • To prevent 1 case of diabetes 5 subjects with IGT for a period of 5 years.

DPP: 3234 participants, for 5 years

0 1 2 3 4

0

10

20

30

40Placebo (n=1082)Metformin (n=1073, p<0.001 vs. Plac)Lifestyle (n=1079, p<0.001 vs. Met , p<0.001 vs. Plac )

Percent developing diabetes

All participants

All participants

Years from randomization

Cum

ula

tive incid

ence (

%)

Placebo (n=1082)

Metformin (n=1073, p<0.001 vs. Placebo)

Lifestyle (n=1079, p<0.001 vs. Metformin , p<0.001 vs. Placebo)

Incidence of Diabetes

Risk reduction

31% by metformin

58% by lifestyle

The DPP Research Group, NEJM 346:393-403, 2002

Placebo

Metformin

Lifestyle

Mean Weight Change

-8

-6

-4

-2

0

0 1 2 3 4

Years from Randomization

Weig

ht

Ch

an

ge (

kg

) Placebo

Metformin

Lifestyle

The DPP Research Group, NEJM 346:393-403, 2002

0

2

4

6

8

0 1 2 3 4

Years from Randomization

ME

T-ho

urs/

wee

k

Placebo Metformin

Lifestyle

Mean Change in Leisure Physical Activity

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Lifestyle modification is better than metformin

• DPPOS study was an extension to DPP and confirmed DPP results over a 10 year follow-up

DPP Research Group. Lancet 2009;374:1677-86

Metformin and Lifestyle Interventions Effectively Delay Diabetes Development for 10 years (DPPOS)

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Diabetes Prevention Program Outcomes Study (DPPOS)

After an average of 10 years follow up, • Patients who were on intensive lifestyle reduced the rate of developing diabetes by 34% and • Delayed the progression to diabetes by about 4 years. • Those treated with metformin reduced the rate of developing diabetes by 18 % and • Delayed diabetes by 2 years.

Lifestyle modification is better than metformin

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Case study

• A 45-year-old woman, has been subjected to health checkup in the office.

• She has a weight of 78 kg, BMI 29. Family h/o DM.

• Her FPG is 115 and PLG is 155 mg/dl.

• GTT 112 / 198 (1hr) / 182 (2hr)

• Her Glycated haemoglobin is 6.2 %

• She has borderline HT, attributes to office stress.

6 months of Lifestyle intervention resulted in 5 kg weight loss and normalization of blood glucose & HbA1c level.

You do get desired result, patients actually do it.

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Results of Indian Diabetes Prevention Programes

Diabetes Care 33:2164–2168, 2010

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Intervention : Recent Literature

Diabetes Prevention in Real World : Diabetes Care 2014 Apr

• Systematic Review and Meta analysis of 22 studies

• Pragmatic Lifestyle Intervention: Programs are effective

• Mean weight loss 2.3 kg (95 % CI, -2.9 to 1.7 )

• More research is needed on, optimal strategies for long term maintenance of weight loss and diabetes prevention.

Postprandial hyperglycaemia increases the risk of CVD and MI

Blood coagulation

Fibrinolysis

IMT

Dyslipidaemia

Insulin resistance

CVD: cardiovascular disease; IMT: intima-media thickness; MI: myocardial infarction; NO: nitric oxide

Postprandial

hyperglycaemia

Oxidative stress

Endothelial

dysfunction

( NO release)

-60

-40

-20

0

20

40

60

RELATIONSHIP BETWEEN WEIGHT CHANGE AND CHD RISK FACTOR SUM: FRAMINGHAM OFFSPRING STUDY

Wilson et al. Arch Intern Med 1999;159:1104.

*P<0.002 vs baseline.

Ch

ange

in R

isk

Fact

or

Sum

(%

)

Men Women

Weight Change During 16-y Follow-up

+20% *

+37% *

* -48%

* -40%

Loss >2.25 kg Gain >2.25 kg

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• Medical nutrition therapy:

Reduction and modification of caloric intake, simple sugars and saturated/hydrogenated fat intake, to achieve weight loss in individuals who are overweight or obese.

• Limited alcohol consumption

• Avoidance of tobacco products

• Adequate quantity and quality of sleep

• Appropriately prescribed physical activity(30 min/day)

• Stress reduction

Therapeutic Lifestyle Management

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EPIC-InterAct Study: DM prevention & fiber

• Cohort of more than 340,000 individuals from 10 European countries designed to investigate the relationships between diet, lifestyle, environment, and chronic diseases.

• 11 years of follow up, the investigators identified 12,403 new cases of type 2 diabetes. (Subcohort of 16,835 controls)

• Investigators found it was highest for cereal fiber (HR 0.81), slightly lower for vegetable fiber (HR 0.84) and absent for fruit fiber (HR 0.98)

Diabetologia. 2015 May 29

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• “The potential mechanisms could include

- feeling physically full for longer,

- prolonged release of hormonal signals,

- slowed down nutrient absorption, or

- altered fermentation in the large intestine.

• All these mechanisms could lead to a lower BMI and reduce risk of developing type 2 diabetes,"

EPIC-InterAct Study: DM prevention & fiber

Diabetologia. 2015 May 29

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Difficulties in maintaining lifestyle modifications

the following strategies have been shown to increase the likelihood of patient success:

• Patient self-monitoring

• Realistic and stepwise goal setting

• Stimulus control

• Cognitive strategies

• Social support

• Appropriate reinforcement

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Do not select Metformin for this purpose

Inspite of the evidence that Metformin helps prevent type 2 DM, it is prescribed only in 3.7% of patients with PreDiabetes. A new retrospective cohort analysis from USA.

Ann Int Med, Apr15

Metformin is not approved for prediabetes in Malaysia, Hongkong, India, Thailand, Pakistan. In Phillipines & Singapore, it is approved after failure of Lifestyle modification.

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The Look AHEAD Research Group

• RESULTS : The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 yrs.

• Weight loss was greater in the intervention group than in the control group throughout the study.

• (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end).

N Engl J Med 2013; 369:145-154

You do get desired result, patients actually do it.

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Avoiding Diabetes Through Action Plan Targeting (ADAPT)

Int J Med Inform 2014 Sep;83(9):636-47

• The trial has developed a system that combines evidence-based interventions for behavioral change with existing health record technology to improve primary care providers’ ability to effectively counsel patients on lifestyle behavior changes.

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Avoiding Diabetes Through Action Plan Targeting (ADAPT)

Int J Med Inform 2014 Sep;83(9):636-47

• The ADAPT system combines

- shared goal setting and feedback,

- patient contracts,

- tailored approaches,

- reminders, and other strategies

to integrate evidence-based behavior change principles into the electronic health record to optimize PCP counseling efficacy during routine visits.

• The ADAPT system has the potential to be an adaptable and scalable technology-enabled behavior change tool for PCPs.

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Interventions: Current Situation

• Lifestyle Modifications • Weight Loss / Maintenance

• Target / Goal - Realistic?

• Intermittent , Face-to-Face Care

• Medication and Monitoring : Not Prescribed

Poor Adherence

Healthcare needs better tools to support patients, and patients need more support

• New Modalities (Diabetes Care, June 2014,37: 1759)

• Internet computer based

• Mobile based : SMS text

• Mobile based : Smartphone app

Need paid hybrid Smartphone + web platform that physicians, nurses, coaches, patients & patients’ family can use easily.

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Impact of technology

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Potential of new way of communication

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Take home message and conclusions

It is extremely important to prevent diabetes, to prevent tsunami of diabetes. Lifestyle modification is the best modality of diabetes prevention. ( strong Evidence-based) LSI is superior to pharmacological therapy in terms of cost and safety.

There are multiple health benefits with lifestyle modification.

There are multiple new ways of implementing LSI, and using future generation apps offers big promise.

Metformin is either not approved, or not prescribed by doctors.

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Social media and behavior change

Review

Are Health Behavior Change Interventions That Use Online

Social Networks Effective? A Systematic Review •Carol A Maher1et al J Med Internet Res 2014 Feb

Thank you for voting in my favor

www.excemed.org

IMPROVING THE PATIENT’S LIFE THROUGH

MEDICAL EDUCATION

4-5 July 2015

MUMBAI, INDIA

2015 Asia Pacific Conference on Cardiometabolic Diseases Management