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Includes the Adobe Acrobat Reader for reading and printing publications.
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Contains the following key public domain (not copyrighted) U.S. Government publication(s) on one CD-ROM in both Microsoft PowerPoint and Adobe Acrobat PDF file formats:
TITLE:
To Prevent / Delay Type 2 Diabetes - A Trail of Evidence . . .67 pages (slides)
SLIDE TOPICS, SUBTOPICS and CONTENTS:
To Prevent / Delay Type 2 Diabetes A Trail of Evidence . . . Presentation Outline General concepts to diabetes specific High risk is high cost Diabetes – the disease burden Diabetes diagnosis Health promotion for patients with diabetes Pre-diabetes Type 2 diabetes Risk factors for Type 2 diabetes Metabolic syndrome Evidence pyramid Risk Assessment Prevention of Type 2 diabetes– evidence from randomized trials, cohort studies, and RCTs Health promotion strategies to prevent / delay Type 2 diabetes High Risk is High Cost ! Low Risk Maintenance: Keep Low Risk, Low Risk ! Why Diabetes Prevention? BUMEDNOTE 6230 (Dec 2004) – “FY2005 Navy Medicine Disease State and Condition Management Program” Great policy guidance to reduce variation in healthcare delivery at all MTFs for target diseases and conditions Diabetes is one of three target disease states for FY2005 2005 focus -- Effective TREATMENT and management of existing diseases and conditions 2006 and beyond – Future BUMEDNOTEs [Hopefully] Integrate PREVENTION into local MTF programs to prevent disease and to stabilize and improve health for patients with certain diseases and conditions Diabetes: The Disease Burden 18 million Americans have diabetes Sixth leading cause of death in US (disease based) Incidence increased 61% since 1991 Individual patients develop considerable collateral damage to multiple organ systems Expensive – $132 Billion per year for diabetes direct and indirect costs (11% of U.S. Healthcare expenditures)
2005 Criteria for the Diagnosis of Diabetes Mellitus Symptoms of diabetes plus casual plasma glucose ≥ 200 mg/dl. Casual is defined as any time of day without regard to time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss. - OR FPG ≥ 126 mg/dl. Fasting is defined as no caloric intake for at least 8 hrs. - OR 2-h postload glucose ≥ 200 mg/dl during an OGTT. The test should be performed as described by WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. Targeted Health Promotion Strategies for Diabetes Disease Management Programs Diabetics - reduce health risks Immunizations (pneumococcal / influenza) Tobacco cessation Glycemic control (HbA1c < 7%) Blood pressure management Cholesterol and lipid management (LDL < 100) Nutrition and weight management Aspirin therapy to prevent cardiovascular events Exercise Impaired Glucose Tolerance (IGT) and Impaired Fasting Glucose (IFG) Pre-diabetes -- Glucose is too high for normal but not diagnostic for diabetes; risk factor for developing diabetes Categories for fasting plasma glucose (FPG) values: FPG < 100 mg/dl = normal fasting glucose FPG 100-125 mg/dl = IFG (impaired fasting glucose) FPG ≥ 126 mg/dl = provisional diagnosis of diabetes (unconfirmed) Categories for 2-h postload glucose values from oral glucose tolerance test (OGTT): 2-h glucose < 140 mg/dl = normal glucose tolerance 2-h glucose 140-199 mg/dl = IGT (impaired glucose tolerance) 2-h glucose ≥ 200 mg/dl = provisional diagnosis of diabetes Diabetes in US 18.2 million people, 90 – 95% Type 2 Diabetes in US 18.2 million people, 90 – 95% Type 2 Type 2 Diabetes Resistance to insulin action AND Relative, rather than absolute, insulin deficiency – inadequate compensatory insulin secretory response Hyperglycemia with pathological (macrovascular & microvascular) and functional changes in target tissues over many years before clinical symptoms Other nomenclature used in the literature Non-insulin dependent diabetes mellitus (NIDDM) Adult onset diabetes mellitus Type II diabetes mellitus
Risk factors, Type 2 diabetes Family history of diabetes (parent or sibling) Race / ethnicity / gender Older age History of gestational diabetes – 20 to 50% chance of diabetes in 5 – 10 years Impaired glucose metabolism (IGT, IFG) Obesity Body fat distribution Physical inactivity
Adjusted Medical Charges by BMI Categories and Health Risk Levels Diabetes Incidence Rate by BMI Categories and Health Risk Levels Total Diabetes Incidence Rate by BMI Categories Total Diabetes Incidence Rate by Health Risk Levels Metabolic Syndrome Definition – NHLBI (ATP III ) Three or more of the following Abdominal obesity - waist circumference Men ≥ 40 in, women ≥ 35 in. High serum triglycerides (≥ 150 mg/dl) Decreased HDL Cholesterol Men < 40 mg/dl, women < 50 mg/dl High blood pressure (≥ 130/ ≥ 85 mm Hg) High fasting glucose (≥ 110 mg/dl) Associated with development of Type 2 diabetes and cardiovascular disease Metabolic Syndrome Prevalence – data from NHANES III (Third National Health and Nutrition Examination Survey JAMA 2002; 287(3):356-359) Overall unadjusted prevalence 22% (Using 2000 census data, 47 million US residents) Rates increase with age (for example) Ages 20 – 29, prevalence 6.7% Ages 60 – 69, prevalence 43.5% Race / gender differences African Americans (57% higher prevalence in women vs. men) Mexican Americans (26% higher prevalence in women vs. men) Finding Individuals at High Risk for Type 2 Diabetes Identify individuals with Pre-diabetes Individuals have no symptoms FPG – patient acceptance. Oral GTT (2-hour) - Used in RCTs; variable acceptance for clinical / public health / population health practice Questionnaires, symptom–risk (Diabetes Care 1997;20:491-6) Online “Diabetes risk test” – http://www.diabetes.org Age, ht., wt., gestational diabetes, family hx., exercise habits Logistic regression prediction model – (San Antonio Heart Study, Ann Intern Med 2002: 136:575-581) “Clinical model” Age, gender, ethnic group, fasting glucose, systolic BP, HDL cholesterol, BMI, family hx. of diabetes Age, gender, ethnic group, family history of diabetes were strongest predictors of diabetes risk Validated in Mexican-American population The Evidence Pyramid What is known about “Preventing or Delaying Type 2 Diabetes?” Randomized trial in Malmo, Sweden “Prevention of type 2 (non-insulin-dependent) diabetes mellitus by diet and physical exercise. The 6-year Malmo feasibility study” (Diabetologia. 1991; 34: 891-8) Uncontrolled study, middle-aged men 5-year protocol – 181 subjects with IGT Dietary changes and physical activity Modest weight loss (2% to 4%) among participants 90% of subjects completed study Normalized glucose tolerance in 50% with impaired IGT Diabetes incidence reduced by 50% What is known about “Preventing or Delaying Type 2 Diabetes?” Prospective Cohort Study “Physical activity and reduced occurrence of non-insulin-dependent diabetes mellitus” (N Engl J Med 1991;325:147-152) Male alumni of U. Pennsylvania sent questionnaires 5990 alumni, 98,524 man-yr follow-up, 1962—1976 Incidence rate for diabetes declined with increased leisure activity (walking, stair climbing, sports, 6% decrease in age-adjusted risk / 500 kcal) Protective effect for physical activity strongest in those at highest risk for NIDDM (high BMI, history hypertension, parental history of diabetes). What is known about “Preventing or Delaying Type 2 Diabetes?” Prospective Cohort Study “A prospective study of exercise and incidence of diabetes among US male physicians” (JAMA 1992;268:63-67) Physicians’ Health Study 21,271 US male physicians, aged 40-84, 5 year protocol, 105,141 person-yr follow-up Exercise at least once per week decreased risk of developing NIDDM by 36% Age adjusted relative risk of NIDDM decreased with increasing frequency of exercise 0.77 one weekly, 0.62 for two to fours times weekly 0.58 for five or more times weekly What is known about “Preventing or Delaying Type 2 Diabetes?” Prospective Cohort Study “Diet, lifestyle, and the risk of type 2 diabetes mellitus in women” (N Engl J Med 2001;345:790-7) Nurses’ Health Study 84,941 US female nurses, 16 year follow-up (1980 to 1996), studied combined effects of dietary and lifestyle factors Overweight or obesity (BMI) was the single most important predictor of Type 2 diabetes (RR of 38.8 for BMI > 35.0; RR of diabetes was 20.1 for BMI of 30.0 to 34.9) Protective effect for women in low risk categories for three factors (BMI, diet, & exercise) RR of diabetes 0.12 Low risk - “Healthy Lifestyle” in Nurses’ Health Study “Diet, lifestyle, and the risk of type 2 diabetes mellitus in women” (N Engl J Med 2001;345:790-7) BMI < 25 Diet high in cereal fiber & polyunsaturated fat, low in saturated fat and trans fats and glycemic load Regular exercise (30 min per day, vigorous to moderate) No current smoking Moderate intake of alcohol (avg. half drink per day) For women with “healthy lifestyles,” incidence of Type 2 diabetes was 90% lower than found in women without these five factors Relative Risk of Type 2 Diabetes Nurses Health Study (N Engl J Med 2001;345:790-7) Three randomized controlled trials – Lifestyle modification decreases incidence of Type 2 diabetes Da Qing, China Study – 577 pts, 6 year study Lifestyle changes – 31% - 46% decreased incidence Diabetes Care 1997; 20(4):537-544 Finnish Diabetes Prevention Study– 4 yrs. Diet and exercise – 58% decrease in incidence N Engl J Med 2001; 344(18):1343-1350 Diabetes Care 2003; 26(12):3230-3236 Diabetes Prevention Program – 27 sites, 4 yrs. Lifestyle changes – 58% decrease in incidence Metformin treatment – 31% decrease in incidence N Engl J Med 2002; 346(6):393-403 Lifestyle modification decreases incidence of Type 2 diabetes Randomized controlled trial Da Qing, China (Diabetes Care 1997; 20(4):537-544) 577 pts with IGT, 6 year study Randomization by 33 clinic sites not by subject All subjects at clinics had same intervention Control group Diet alone Exercise alone Diet plus exercise RCT - Da Qing, China Research Design Control group – general information about diet and IGT; brochures; no individual or group counseling Diet alone Dietary advice varied by BMI; weight reduction if BMI >=25 Individual counseling; Counseling (small groups) weekly x 1 mo; monthly x 3 months, then q3 months Exercise alone – taught and encouraged to increase leisure physical activity by 1 U/day and by 2 U/day for those < 50 y/o Counseling (small groups) weekly x 1 mo; monthly x 3 months, then q3 months Diet plus exercise RCT - Da Qing, China Incidence of Diabetes (NIDDM) RCT - Da Qing, China Cumulative Incidence of Diabetes (NIDDM) Control group – 0% Diet alone – 31% reduction (P < 0.03) Exercise alone – 46% reduction (P < 0.0005) Diet plus exercise – 42% reduction (P < 0.005) Model adjusted for baseline FPG and BMI
Lifestyle modification decreases incidence of Type 2 diabetes Randomized controlled trial Finnish Diabetes Prevention Study N Engl J Med 2001; 344(18):1343-1350 522 pts middle-aged, overweight (BMI >=25; 55% BMI >30 ), impaired GTT, 5 study centers, study ended early Recruited by screening high risk groups, including first-degree relatives of patients with Type 2 diabetes who voluntarily responded to local advertising Study the feasibility and effects of lifestyle changes to prevent or delay the onset of Type 2 diabetes in subjects with IGT; test an intervention feasible for primary health care. RCT - Finnish Diabetes Prevention Study Research Design Control group – general oral and written information about diet (two-page leaflet) and exercise with 3-day food diary at baseline and at annual visits; no individualized programs Intervention group – detailed individual advice to achieve five goals Reduction in weight of 5% or more Moderate intensity exercise for at least 30 minutes per day Dietary fat to be less than 30% of calories Saturated fat in diet to be less than 10% of calories Increase fiber intake to at least 15 g. per 1000 kcal. Study team – physician, nurse, nutritionist, exercise instructor RCT - Finnish Diabetes Prevention Study Research Design – First year, intensive intervention Intervention group – detailed individual advice on diet Dietary content – Whole grains, vegetables, fruits, low-fat milk, low-fat meats, soft margarine, vegetable oils rich in monounsaturated fats Adjustment of diet based upon 3-day food diary – four times per year Each subject has seven sessions (30-60 min) with a nutritionist in the first year plus voluntary group sessions Each subject had one session every three months thereafter Intervention group – detailed individual advice on exercise Endurance exercises (walking, jogging, swimming, ball games, skiiing) recommended to increase aerobic capacity Supervised, individually tailored, progressive circuit-training resistance exercises to improve strength of large muscle groups Exercise competition, twice, between five study centers
RCT - Finnish Diabetes Prevention Study Results Intervention group – significant changes compared to controls (first year) Weight (about 5% decrease vs 1% decrease in controls) Waist circumference Glucose levels (FPG, 2hr post load 75 g glucose challenge Blood pressure (systolic and diastolic) Intervention group – first year, 50–85 percent participation in circuit–type resistance training exercise sessions Cumulative incidence of diabetes – 58% lower in intervention group; 63% lower for men in intervention group; 54% lower among women NNT -- 22 patients for one year or 5 patients for five years Finnish Diabetes Prevention Study Self-reported Changes in Diet and Exercise Habits, Year One Finnish Diabetes Prevention Study Success in Reaching Lifestyle Goals Year One RCT - Finnish Diabetes Prevention Study Incidence of Diabetes (First Year) Lifestyle modification decreases incidence of Type 2 diabetes Randomized controlled trial Diabetes Prevention Program (DPP) Study N Engl J Med 2001; 344(18):1343-1350 Largest number of patients in RCT to prevent diabetes Three interventions 27 sites in USA Standardized methods: Protocol and procedures manual Staff training DPP - Eligibility Criteria Age > 25 years Elevated plasma glucose 2 hour glucose 140-199 mg/dl (7.8- <11.1 mmol/L) and Fasting glucose 95-125 mg/dl (5.3- <7.0 mmol/L) Body mass index > 24 kg/m2 All racial and ethnic groups goal of up to 50% from high risk populations DPP Population DPP Population Sex Distribution Age Distribution DPP - Interventions RCT - Diabetes Prevention Program – USA Research Design – Three groups Control group + Standard Lifestyle Placebo medication + standard lifestyle recommendations (written information about diet and exercise and annual 20 – 30 min individual counseling on healthy lifestyle, diet, & exercise) Medication group + Standard Lifestyle Metformin medication (850 mg twice daily + standard lifestyle recommendations (written information about diet and exercise and annual 20 – 30 min individual counseling on healthy lifestyle, diet, & exercise) Intensive Lifestyle Intervention DPP - Lifestyle Intervention An intensive lifestyle intervention program with specific goals: Achieve > 7% loss of body weight and maintain weight reduction Healthy diet Low-fat < 25% of calories from fat Low-calorie -- 1200-1800 kcal/day Physical activity at moderate intensity > 150 minutes per week DPP - Lifestyle Intervention Structure 16 session core curriculum (over 24 weeks) Long-term maintenance program Supervised by a case manager Access to lifestyle support staff Dietitian Behavior counselor Exercise specialist
DPP - The Core Curriculum 16 session course conducted over 24 weeks Education and training in diet, and exercise methods and behavior modification skills Emphasis on: Self monitoring techniques Problem solving Individualizing programs Self esteem, empowerment, and social support
DPP - Post Core Program Self-monitoring and other behavioral strategies Monthly visits Must be seen in person at least every two months Supervised exercise sessions offered Periodic group classes and motivational campaigns Tool box strategies Provide exercise videotapes, pedometers Enroll in health club or cooking class
Diabetes Prevention Program Intensive Lifestyle Intervention Results 50% of subjects achieved weight loss of 7% or more at 24 weeks 74% of subjects at 24 weeks met the goal of > 150 minutes of activity per week Average weight loss was 5.6 kg, compared to 2.1 kg for metformin and 0.1 kg for placebo (P < 0.001) Mean Weight Change Mean Change in Leisure Physical Activity
Diabetes Incidence Rates by Age Diabetes Incidence Rates by Sex Diabetes Incidence Rates by Ethnicity Diabetes Incidence Rates by BMI Diabetes Prevention Program Study Effect of Intervention on Incidence of Type 2 Diabetes Lifestyle modification decreases incidence of Type 2 diabetes Summary of two RCTs Finnish Diabetes Prevention Study 522 pts, overweight (BMI >=25), impaired GTT Diet and exercise – 58% decrease in incidence Weight loss – 5% or more, nutrition counseling Fat intake < 30% calories, sat fat <10% calories, increase fiber intake (15 g/1000 kcal) Exercise – moderate, at least 30 min per day Diabetes Prevention Program 3234 pts, 27 sites, BMI >=24, impaired GTT Lifestyle changes – 58% decrease in incidence Weight loss – 7%, low calorie, low fat diet Physical activity – 150 minutes per week Prevent / Delay Type 2 Diabetes Four randomized controlled trials – Medications decrease incidence of Type 2 diabetes Diabetes Prevention Program – 1073 pts., 27 sites, 4 yrs. Double-blind, placebo-controlled trial, NNT 13 pts for 3 yrs. Metformin treatment + lifestyle advice – 31% decrease in incidence Metformin – biguanide; decreases hepatic glucose output and increases insulin action N Engl J Med 2002; 346(6):393-403 STOP – NIDDM Trial – 714 pts., 9 countries, 3.3 yrs avg f/u. Double-blind, placebo-controlled trial – NNT 11 pts. for 3.3 yrs. Acarbose treatment (100 mg three times / d) – 32% decrease in risk Acarbose – α-glucosidase inhibitor, decreases insulin resistance and postprandial hyperglyemia Pts. often discontinued meds (acarbose – 31%, placebo – 19%) Lancet 2002; 359:2072-77 Prevent / Delay Type 2 Diabetes Four randomized controlled trials – Medications decrease incidence of Type 2 diabetes Troglitazone in Prevention of Diabetes (TRIPOD) Study 266 pts., Hispanic women with previous GDM, 30 mo. median f/u Troglitazone treatment + lifestyle advice– 56% decrease in incidence Troglitazone – reduces insulin resistance Troglitazone no longer marketed in US Diabetes 2002; 51:2796-2803 XENical in the Prevention of Diabetes in Obese Subject (XENDOS) Study – 3305 pts., 22 sites, 4 yrs. Double-blind, placebo-controlled trial – NNT 11 pts. for 3.3 yrs. Moderate lifestyle changes plus drug (Orlistat or placebo) Orlistat (120 mg three times daily) – 37% decrease in risk Orlistat – gastrointestinal lipase inhibitor, weight loss drug Diabetes Care 2004; 27:155-161 To Prevent / Delay Type 2 Diabetes . . . Summary of the Evidence Excellence evidence that Type 2 diabetes in adults can be prevented or delayed (three to six years) Multiple RCTs with similar interventions reduce incidence Modest weight loss (5% to 7% of body weight) Moderate intensity exercise up to 150 min / week Healthier diet Incidence of Type 2 diabetes decreased by 31% to 58% Dose response for exercise seen in both RCTs and cohort studies Dose response for multiple risk factors in Finnish DPS Intensive lifestyle interventions had similar or stronger effects than medications alone No published RCT has randomized lifestyle interventions AND medications to prevent or delay Type 2 diabetes Prevent / Delay Type 2 Diabetes How Could This Information Influence Health Promotion Programs Integrate PREVENTION in diabetes disease management plans Focus existing HP programs outcomes onto diabetes cohort – immunizations, tobacco cessation, blood pressure, cholesterol Screen for individuals at high risk to develop Type 2 diabetes What method will you use? Will your method be cost effective? Early identification of the metabolic syndrome (Elective determination of BMI and waist circumference at PRT screening) Comprehensive lifestyle modification programs Risk factor reduction Low risk factor maintenance IRB approved clinical research for prevention and wellness Creating Healthy Populations
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