prevention of type 2 diabetes mellitus 1. introduction

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Prevention of Type 2 Diabetes Mellitus

1. Introduction

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Prevention of Type 2 Diabetes Mellitus:

This presentation focuses on the prevention of type 2 diabetes mellitus, addressing key questions with respect to why such prevention is imperative. It Includes studies supporting how type 2 diabetes may be prevented or delayed and a call to action.


1.2 Learning Outcomes

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1.3 Why Don't People Change?

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Why is Prevention of Type 2 Diabetes Imperative? presents information focusing on the projected future U.S. diabetes population and suggests a link between the growing numbers of obese individuals and increase in diagnosed diabetes.

1.4 Future Diabetes Population in U.S.

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This is the projected future percentage of the U.S. population with diabetes. The anticipated steady growth in diabetes, from 14.5%14.5% in 2010 to 25.6% in 2030 and 32.7% in 2050, or from approximately 1 in 7 to 1 in 3 individuals, underscores the imperative for preventing both obesity and diabetes.


1.5 Obesity and Diabetes in the US

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Age-adjusted percentage of American adults who were obese (defined as BMI ≥30 kg/m2; top row) or who had diagnosed diabetes (bottom row) for the years 1994, 2000, and 20081

The prevalence of diagnosed diabetes and selected risk factors by county was estimated using data from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System (BRFSS)1 and data from the U.S. Census Bureau's Population Estimates Program2. The surveillance is an ongoing, monthly, state-based telephone survey of the adult population. The survey provides state-specific information on behavioral risk factors and preventive health practices. Respondents were considered to have diabetes (either type 1 or type 2) if they responded “yes” to the question, “Has a doctor ever told you that you have diabetes?”. Respondents were considered obese if their BMI was ≥30 kg/m2, derived from self-report of height and weight. Between 1994 and 2008, the percentage of individuals defined as obese increased, as did the percentage of those with diagnosed diabetes.


2. Type 2 Diabetes Prevention Studies

2.1 Lifestyle Interventions

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Lifestyle interventions can prevent type 2 diabetes onset:

Several randomized clinical trials have shown that individuals at high risk for developing diabetes, for example those with impaired fasting glucose [IFG] or impaired glucose tolerance [IGT], or both, can be given interventions that significantly decrease rate of onset of diabetes. Results of a few of the studies highlighted here are explored in subsequent slides.


2.2 Finnish Diabetes Prevention Study

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In the Finnish Diabetes Prevention Study, 522 overweight (BMI ≥25 kg/m2) men and women ages 40 to 65 years with impaired glucose tolerance (IGT, defined as plasma glucose concentration 140-200 mg/dL 2 hours following an oral glucose challenge) were randomly assigned to either a control group or to a lifestyle intervention group. In the control group, 91 men and 174 women were given general oral and written information about diet in the form of a 2-page leaflet, and exercise at baseline and at annual visits. No specific individualized programs were offered. A 3-day food diary was completed at baseline and at each annual visit; nutrient intakes were then computed.

In the intervention group, 81 men and 176 women were given detailed advice about how to achieve the goals of the intervention, which were to reduce weight by 5% or more, reduce total intake of fat to <30% and saturated fat to <10% of energy consumed, increase fiber intake to at least 15 g/1,000 kilocalories and moderate exercise for at least 30 minutes/day. Dietary advice was tailored to each subject on the basis of 3-day food records completed 4 times annually; participants had 7 sessions with a nutritionist during the first year of the study and 1 session every 3 months thereafter and received individual guidance on increasing level of physical activity. Primary outcome was diagnosed diabetes which at that time meant a fasting plasma glucose of 140 mg/dL or higher or a plasma glucose concentration of 200 mg/dL or higher 2 hours following an oral glucose challenge.


2.3 Study Objective

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The objective of the Finnish Diabetes Prevention Study was to determine the feasibility and effects of lifestyle changes designed to prevent or delay the onset of type 2 diabetes in those with impaired glucose tolerance. The mean duration of study follow-up was 3.2 years. At the end of Year 1, weight loss was a mean of 0.8±3.7 kg in the control group and 4.2±5.1 kg in the intervention group; at Year 2, weight loss was 0.8±4.4 kg in the control group and 3.5±5.5 in the intervention group (which was statistically significant). After 4 years, the incidence of diabetes was 11% in the intervention group compared with 23% in the control group. Diabetes was 58% lower in the intervention group than in the control group. Among those in the intervention group, incidence of diabetes was 63% lower among men and 54% lower among women. This was the first time it was demonstrated that diabetes could be prevented with lifestyle changes.


2.4 Study Conclusion

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The authors concluded that type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects, defined as those with impaired glucose tolerance, which represented an intermediate category between normal glucose tolerance and overt diabetes. Strong evidence suggests modifiable risk factors such as obesity and physical inactivity are the primary non-genetic determinants of type 2 diabetes. Results of this study have found that to prevent 1 case of diabetes, 22 subjects with impaired glucose tolerance must be treated with lifestyle intervention for 1 year, or 5 subjects for 5 years.


2.5 Diabetes Prevention Program

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From 1996-1999, the Diabetes Prevention Program Research Group randomly assigned 3,234 non-diabetic individuals at high risk for diabetes, that is, those with elevated fasting and post-load plasma glucose concentrations, with a BMI ≥24 kg/m2 (or ≥22 kg/m2 in Asians) to:

Standard lifestyle + placebo (n=1082)

Standard lifestyle + metformin (initiated at 850 mg orally once daily and, at one month, increased to twice daily)

Intensive lifestyle intervention (n=1079)

“Standard lifestyle” included written information and an annual 20-30 minute individual session that emphasized the importance of a healthy lifestyle such as following the food pyramid guide, reducing weight, and increasing physical activity.

Primary outcome was diabetes, diagnosed on the basis of an annual oral glucose-tolerance test or a semiannual fasting plasma glucose test

Participants Button:

Diabetes Prevention Program Participants:

The mean age of the participants in the Diabetes Prevention Study was about 51 years. Of the participants, 68% were women and 45% were members of minority groups (19.9% African American, 15.7% Hispanic, 5.3% American Indian, and 4.4% Asian). Average follow-up after the active intervention was 2.8 years (range, 1.8-4.6 years)


Audio Participants (Slide Layer)

2.6 Goals

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Goals of Intensive lifestyle intervention:

In the intensive lifestyle intervention arm of the Diabetes Prevention Program study, participants were asked to lose 7% of their body weight and maintain it by keeping dietary fat to 25% of kilocalories, which were calculated at 1200-1800 kcal/day based on a patient's initial body weight, and to engage in physical activity at least 150


minutes weekly. A 16-lesson curriculum designed to help participants achieve their goals was taught on a one-to-one basis during the first 24 weeks following enrollment and was individualized. Subsequent individual (monthly) and group sessions helped to reinforce behavioral changes.

2.7 Weight Loss Results

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Participants in the Diabetes Prevention Program who were assigned to lifestyle intervention had much greater weight loss and a greater increase in physical activity than those assigned to treatment with metformin or placebo. Metformin and lifestyle intervention were similarly effective in restoring normal fasting glucose values; however, lifestyle intervention was more effective in restoring normal post-load glucose values. Average weight loss was 5.6 kg in the lifestyle group, 2.1 kg in the metformin group, and 0.1 kg in the placebo group. This was truly a landmark study where lifestyle interventions outperformed medications for preventing diabetes.

Button Results:

The results in the intensive lifestyle intervention group, half (50%) of the patients had achieved the goal of weight loss of 7% or more by the end of the 24 week curriculum and 38% had a weight loss of at least 7% at the most recent study visit. Assessed by logs the participants kept, 74% had met the goal of at least 150 minutes of physical activity/week at 24 weeks and 58% at the most recent study visit.


Results Intensive Lifestyle (Slide Layer)

Results Metformin (Slide Layer)


2.8 Incidence and Risk Reduction

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In general, the intensive lifestyle intervention was more effective than either metformin or placebo.1 When the effect of metformin or intensive lifestyle intervention was examined by subgroup, the effect of metformin was less in those who had a lower BMI or a lower fasting glucose concentration than in those with higher values for those variables. There were no differences by gender, age or ethnicity.1 Metformin was more effective in those with a fasting plasma glucose >110 mg/dL, in individuals younger than 60 years, and in those with a higher BMI (>35 kg/m2); however, metformin was not significantly better than placebo in those >60 years of age.1 Based on these findings, metformin may reasonably be recommended for very high-risk individuals; that is, those with risk factors for diabetes and/or more severe or progressive hyperglycemia.2


2.9 Medication Study ACT NOW

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Interventions that may prevent or delay impaired glucose tolerance, which is associated with cardiovascular disease and conversion to type 2 diabetes mellitus are clinically important. The double-blind, placebo-controlled Act Now for Prevention of Diabetes (ACT NOW) study randomly assigned 602 adults with type 2 diabetes mellitus with impaired glucose tolerance to pioglitazone (n=303) or placebo (n=299) to determine whether pioglitazone could reduce the risk of type 2 diabetes. Median follow-up was 2.4 years. Fasting glucose was measured quarterly and oral glucose tolerance tests, annually. Annual incidence rates for type 2 diabetes mellitus were 2.1% in the pioglitazone group vs 7.6% in the placebo arm; compared with placebo, pioglitazone reduced the risk of type 2 diabetes mellitus by 72%. Conversion to normal glucose tolerance occurred in 48% of patients in the pioglitazone group vs 28% in the placebo group. Treatment with pioglitazone vs placebo was associated with significantly reduced levels of fasting glucose, 2-hour glucose, and HbA1c. Weight gain was greater with pioglitazone and edema was more frequent.


2.10 Sustained Effects of Prevention Interventions

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Do Prevention Interventions Have Sustained Effects, includes a review of lifestyle interventions, and medications on preventing, and delaying type 2 diabetes mellitus.

Finnish DPS: Extended follow-up of the Finnish Diabetes Prevention Study assessed the extent to which the originally achieved lifestyle changes and risk reduction remained after discontinuation of active counseling. After 4 years of active intervention, participants who were still free of diabetes were further followed up for 3 years for a total follow-up of 7 years. The investigators measured diabetes incidence, body weight, physical activity, and dietary intakes of fat, saturated fat, and fiber. At 7 years, incidence of type 2 diabetes was 43% lower in the intervention than in the control arm.

Risk reduction was found to be related to success in achieving intervention goals of weight loss, reduced intake of total and saturated fat , increased intake of dietary fiber, and increased physical activity. The investigators concluded that lifestyle intervention in people at high risk for type 2 diabetes resulted in sustained lifestyle changes and a reduction in diabetes incidence that remained after individual lifestyle counseling ceased.

Metformin:

Metformin significantly reduced risk of diabetes in individuals with impaired glucose tolerance who participated in the Diabetes Prevention Program. Diabetes status was assessed by oral glucose tolerance tests (OGTTs) in participants still taking metformin. A repeat oral glucose tolerance test was performed after a brief (1-2 week) washout period in which study medication was withheld. Primary analysis of the study demonstrated that metformin decreased risk of diabetes by 31%. This study shows that 26% of this effect can be accounted for by a pharmacological effect of metformin that did not persist when the drug was stopped. After the washout the incidence of diabetes was still reduced by 25%.


All Studies

This slide summarizes results of the studies just discussed. As results have shown, lifestyle interventions appear to continue to have a long-term, sustained effect compared with pharmacologic treatments.

FinnishAt 7 years, the incidence of diabetes was 43% lower in the intervention than in

the control group

Risk reduction was related to success in achieving goals for weight loss, intake of

saturated fat, fiber and increased physical activity

Lifestyle intervention in people at high risk for type 2 diabetes resulted in sustained

lifestyle changes and a reduction in diabetes incidence that remained after individual

lifestyle counseling ceased

(Slide Layer)


Metformin (Slide Layer)

All Studies (Slide Layer)


2.11 10-Year Follow-Up Study

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Are We Preventing Type 2 Diabetes or Delaying It? examines results of the 10-year follow-up of the Diabetes Prevention Program.

10-year follow-up after the Diabetes Prevention Program found that prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years. We can see that the incidence of diabetes remained lowest in the lifestyle group.


2.12 Cost Effectiveness

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Is Diabetes Prevention Cost-Effective? looks at the cost-effectiveness of lifestyle modification or metformin compared with placebo based on results from the Diabetes Prevention Program. This is important because an intervention program must be cost-effective if it is to be translated into real-world practice.

Published in 2005, this study estimated the lifetime cost-utility of lifestyle modification or metformin based on data from the Diabetes Prevention Program. Intensive lifestyle intervention not only delayed onset and reduced the incidence of type 2 diabetes substantially compared with metformin, but life expectancy increased slightly. Overall, cost per quality adjusted life year (QALY) was $1,124 for lifestyle intervention compared with $31,286 for metformin.

The Diabetes Prevention Program (DPP) and its Outcomes Study (DPPOS) demonstrated that either intensive lifestyle intervention or metformin could prevent type 2 diabetes in high-risk adults for at least 10 years after randomization. This study reported the 10-year within trial cost-effectiveness of the interventions, either intensive lifestyle or treatment with metformin. Prospective data on resource utilization, cost, and quality of life were collected. Economic analyses were performed from health system and societal perspectives.

Detailed cost-effectiveness analyses found that in the diabetes prevention program, lifestyle was cost-effective and metformin was marginally cost-saving compared with placebo over 10 years. The conclusion to be drawn from this landmark study is that

investment in lifestyle and metformin interventions for diabetes prevention in high-risk adults provides good value for the money spent.


2.13 Lower-Cost Settting Evidence-based Intervention Studies

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Can Evidence-Based Interventions Be Delivered Effectively in Lower-Cost Settings?” examines three studies.

DEPLOY, the first study to demonstrate the YMCA is a promising vehicle for disseminating Diabetes Prevention Program lifestyle intervention into the community, demonstrated a significant reduction in weight, BMI, and total cholesterol after 4-6 month.

POWER found that significant weight loss can be sustained over 2 years with both in-person and remote-only behavioral weight-loss interventions.

Employing Diabetes TeleHealth to institute a diabetes self-management education (DSME) intervention was found to improve metabolic control and reduce cardiovascular risk in an ethnically diverse, rural population.

DEPLOY:

This is the first study to demonstrate the YMCA is a promising vehicle for disseminating the diabetes prevention program lifestyle intervention into the community. The DEPLOY (Diabetes Education & Prevention with a Lifestyle Intervention Offered at the YMCA) Pilot Study randomized 92 adults to either a group lifestyle intervention (n=46) or control (brief counseling; n=46) at two YMCA facilities in Indiana. Adults had a BMI ≥24 kg/m2, ≥2 diabetes risk factors, and a casual capillary blood glucose 110-199 mg/dL. The 4-6-month follow-up visit was completed by 83% of those in the control group and 85% in the intervention group.

Compared with the control group, adults at high risk for developing diabetes significantly achieved and maintained: a mean 6% reduction in baseline body weight, a mean 6% reduction in BMI, and a mean 22 mg/dL reduction in total cholesterol. These differences were sustained after 12 months.


POWER:

This 2-year trial, randomized 415 patients with a baseline body mass index (BMI) of 36.6, a mean weight of 104 kg, and at least one cardiovascular risk factor to one of two behavioral weight-loss interventions in which primary care providers reinforced participation at routinely scheduled visits:

1) Remote weight-loss support via telephone, a study-specific Web site, and e-mail;

2) In-person support during group and individual sessions plus remote support as above;

3) In the control arm, weight loss was self-directed.

The mean age was 54 years; 64% were women and 41% were black. At 2 years, mean change in weight from baseline was 0.8 kg in the control group, 4.6 kg in the remote support only group, and 5.1 kg in the in-person support group. The percentage of those losing ≥5% of initial weight was 18.8% in the control group, 38.2% in the remote-support only group, and 41.4% in the in-person support group. Weight change from baseline did not differ significantly between the two behavioral weight-loss intervention groups. The study concluded that behavioral interventions, both in-person and remotely, can help obese patients achieve and sustain significant weight loss.

TeleHealth:

This 1-year randomized trial evaluated a remote comprehensive diabetes self-management education intervention, Diabetes TeleCare, in a population treated at a federally qualified health center in rural South Carolina. Participants were randomized to Diabetes TeleCare, a 12-month, 13-session curriculum delivered by a dietitian and nurse or certified diabetes educator using telehealth strategies, or usual care. As shown on this slide, improvement in glycated hemoglobin (GHb) was significantly greater in the intervention group compared with usual care from baseline to 6 and 12 months. In a subset of the sample who completed a 24-month follow-up visit, glycated hemoglobin was reduced from baseline to 12 and 24 months in the Diabetes TeleCare group. Improvement in LDL cholesterol was also significantly greater in the intervention group vs. usual care. The study found that employing Diabetes TeleHealth to institute a diabetes self-management education intervention improved metabolic control and reduced cardiovascular risk in an ethnically diverse, rural population.


DEPLOY

POWER


TeleHealth

3.10 End of Presentation

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3.11 Take Out Menu

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In the absence of risk factor criteria, testing diabetes should begin at age 45 years. If results are normal, testing should be repeated at least at 3-year intervals, with consideration of more frequent testing depending on initial results and risk status. Age is a major risk factor for diabetes; therefore, testing of individuals without other risk factors should begin no later than at age 45 years. The rationale for the 3-year interval is that false negatives will be repeated before substantial time elapses, and there is little likelihood that an individual will develop significant complications of diabetes within 3 years of a negative test result. Given the need for follow-up and discussion of abnormal results, testing should be conducted within the health care setting. Community screening outside a health care setting is not recommended because people with positive tests may not seek, or have access to, appropriate follow-up testing and care. Conversely, there may be failure to ensure appropriate repeat testing for individuals who test negative. Community screening may also be poorly targeted - it may fail to reach the groups most at risk and inappropriately test those at low risk (the worried well) or even those already diagnosed.

prevention of type 2 diabetes mellitus 1. introduction

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