Implications of The LookAHEAD Trial: Is Weight Loss Beneficial for Patients with Diabetes?
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1 Implications of The LookAHEAD Trial: Is Weight Loss Beneficial for Patients with Diabetes? Boston, MA November 7, 213 Edward S. Horton, MD Professor of Medicine Harvard Medical School Senior Investigator Joslin Diabetes Center Global Projections for the Diabetes Epidemic: World 211 = 366 M 23 = 552 M >51% NAC 37.7 M 51.2 M 36% SACA 25.1 M 39.9 M 59% EUR 52.8 M WP 64.2 M MENA SEA 22% M 32.6 M 59.7 M 83% AFR 14.7 M 28. M 9% 71.4 M 121 M 69% M 6% M = million, AFR = Africa, NAC = North America and Caribbean, EUR = Europe, SACA = South and Central America, MENA = Middle East and North Africa, SEA = South-East Asia, WP = Western Pacific Diabetes Atlas Committee. Diabetes Atlas 5th Edition: IDF 211. Obesity is the Primary Risk Factor for Type 2 Diabetes 5 4 Age-adjusted relative risk of type 2 diabetes 1 Men 1 Women < < BMI 1 Chan JM et al. Diabetes Care 1994;17: ; 2 Colditz G et al. Ann Intern Med 1995;122:
2 The Dual Epidemic: Obesity and Diabetes 65% of adult Americans are overweight (BMI >25) and 32% are obese (BMI >3). 34% have the Metabolic Syndrome (ATP III criteria). There are now an estimated 25.8 million people with DM in the USA (11.3% of adults) and 79 million with Pre-diabetes (IFG/IGT). The lifetime risk of developing DM for people born in 2 is 33% for men and 39% for women. In this population CVD is the major cause of mortality. Look AHEAD Clinical Trial AIM: To determine whether cardiovascular morbidity and mortality in persons with type 2 diabetes can be reduced through intensive lifestyle intervention aimed at producing and maintaining weight loss. 2
3 Primary Outcome The incidence rate of the first post-randomization occurrence of a composite outcome, including cardiovascular death (fatal myocardial infarction and stroke) non-fatal myocardial infarction non-fatal stroke hospitalization for angina over 13.5 yr. follow-up is reduced in the Lifestyle Intervention compared to Diabetes Support and Education. Secondary Outcomes Composite #1 CVD death Non fatal MI Non fatal stroke Composite #2 All cause death Non fatal MI Non fatal stroke Hospitalization for angina Composite #3 All cause death Non fatal MI Non fatal stroke Hospitalization for angina Hospitalization for CHF CABG Carotid endarterectomy Peripheral vascular disease Look AHEAD Interventions Intensive Lifestyle Intervention () Diabetes Support & Education () 3
4 Power Analysis With planned sample of 5, participants, Look AHEAD had greater than 8% probability of detecting an 18% difference in CVD events between the two arms, assuming two sided alpha of.5 primary outcome rate of 2% per year in planned maximum follow up of 13.5 years. Baseline Characteristics of Participants Lifestyle (N=257) (N=2575) Women 59% 6% Minority 37% 37% Age (years) Insulin Users 15% 16% Baseline BMI Baseline Weight (kg) Baseline Waist (cm) History of Prior CVD Event 15% 14% Lifestyle Intervention: Phase I Weight Loss Induction Months 1-6 Weekly contact 3 group sessions/month 1 individual session/month Personal weight loss goal = 1% Study weight loss goal > 7% 4
5 Recommendations Dietary Intake kcal/day < 25 lb kcal/day > 25 lb < 3% calories from fat meal replacements menu plans Physical Activity gradual increase 175 min/wk 1, steps/day (approx. 5 miles) Lifestyle Intervention: Phase II, Weight Loss Maintenance Months 7-12 Reduced contact 2 group sessions/month 1 individual session/month 2 face-to-face contacts/month required; 3 recommended Individual weight loss goal continue weight loss if < 1% weight maintenance if > 1% Diabetes Support and Education 3-4 meetings / year to promote retention health education topics diet exercise social support 5
6 % Weight Loss at 1-Year % Weight Change p <.1.7% % 1-Year Changes in Markers of Diabetes Control Markers of Diabetes Control P-value Hemoglobin A1c (%), BL Hemoglobin A1c (%), Y Fasting glucose (mg/dl), BL Fasting glucose (mg/dl), Y Diabetes medications, BL Diabetes medications, Y1 86.5% 78.6% -7.8% 86.5% 88.7% 2.2%.93 1-Year Changes in Markers of Blood Pressure Control Markers of Blood Pressure Control P-value Systolic BP (mmhg), BL Systolic BP (mmhg), Y Diastolic BP (mmhg), BL Diastolic BP (mmhg), Y Antihypertensive medications, BL Antihypertensive medications, Y1 75.3% 75.2% -.1% 73.7% 75.9% 2.2%
7 1-Year Changes in Markers of Lipid Control Markers of Lipid Control P-value LDL-cholesterol (mg/dl), BL LDL-cholesterol (mg/dl), Y HDL-cholesterol (mg/dl), BL HDL-cholesterol (mg/dl), Y1 Triglycerides (mg/dl), BL Triglycerides (mg/dl), Y1 Lipid lowering medications, BL Lipid lowering medications, Y % 53.% 3.7% % 57.8% 9.4% Four Year Results Percent Weight Change from Baseline Repeated Measures Adjusted for Clinic and Baseline Level P-value for average effect across all visits: p<.1 % Weight change from baseline P-value Baseline (kg) NS Y1 BL <.1 Y2 BL <.1 Y3 BL <.1 Y4 BL <.1 Year 7
8 Percent Fitness Change from Baseline Repeated Measures Adjusting for Clinic and Baseline Level P-value for average effect across all visits: p<.1 % Fitness change from baseline P-value (METS) (METS) Baseline NS Y1 BL <.1 Y4 BL < Year Diabetes Control HbA1c Change from Baseline P-value for average effect across all visits: p<.1 A1c change from baseline P-value Baseline NS Y1 BL <.1 Y2 BL <.1 Y3 BL <.1 Y4 BL Year Blood Pressure Control SBP (mmhg) Change from Baseline P-value for average effect across all visits: p<.1 SBP change from baseline (mmhg) Year P-value (mmhg) (mmhg) Baseline NS Y1 BL <.1 Y2 BL <.1 Y3 BL Y4 BL
9 Blood Pressure Control DBP (mmhg) Change from Baseline Repeated Measures Adjusting for Clinic and Baseline Level P-value for average effect across all visits: p=.1 DBP change from baseline (mmhg) Year P- value (mmhg) (mmhg) Baseline NS Y1 BL <.1 Y2 BL Y3 BL Y4 BL Lipid Control HDL Cholesterol (mg/dl) Change from Baseline P-value for average effect across all visits: p<.1 HDL change from baseline (mg/dl) Year P-value (mg/dl) (mg/dl) Baseline NS Y1 BL <.1 Y2 BL <.1 Y3 BL <.1 Y4 BL <.1 Lipid Control Triglyceride (mg/dl) Change from Baseline P-value for average effect across all visits =.1 Trig change from baseline (mg/dl) Year P-value (mg/dl) (mg/dl) Baseline NS Y1 BL <.1 Y2 BL Y3 BL Y4 BL
10 Lipid Control LDL Cholesterol (mg/dl) Change from Baseline Repeated Measures Adjusting for Clinic and Baseline Level P-value for average effect across all visits: p=.9 LDL change from baseline (mg/dl) Year P-value (mg/dl) (mg/dl) Baseline NS Y1 BL Y2 BL Y3 BL Y4 BL LDL levels fell substantially in both groups over time Ten Year Results had significantly greater weight loss than 1
11 A1c Blood Pressure HDL C and Triglycerides 11
12 had significantly greater reductions in LDL Cholesterol than participants had significantly greater use of medications than Antihypertensive HR=.88 (.78,.89) p=.26 Statins HR=.86 (.78,.94) p =.1 Insulin HR=.74 (.66,.82) p <.1 Differences between and had better weight losses throughout the trial had greater improvements in fitness reduced glycated hemoglobin and need for insulin led to sustained improvements in SBP and HDL C had less improvement in LDL C but also used fewer statins than 12
13 BUT Did reduce cardiovascular morbidity and mortality? Analysis of time to first post randomization occurrence of primary and secondary outcomes in the two groups. Cumulative Hazard for Primary Outcome Non Significant Interaction (p =.6) with CVD History HR =.86 (.72, 1.2) HR = 1.13 (.9, 1.42) 13
14 Subgroup Analyses NOTE: Race/ethnicity groups with smaller numbers of participants are omitted from this table. Primary Study Question Answered 1. No significant difference between and in number of heart disease events that is both groups had a similar number of cardiovascular events. Main study answer was negative. 2. Both groups had a very low number of heart disease events. Both groups had less than half of the expected events. Good news for all. Why did we have so few CVD events? Many participants are taking medication for their diabetes, high blood pressure and high cholesterol (more so in than in ). These medications combined with regular checkups with a health professional may have kept CVD rates low in both groups These results parallel the overall improvement in CVD in the US in recent years 14
15 Other Outcomes Currently Being Analyzed More participants in than in had improvements in Obstructive Sleep Apnea at year % of Participants Same 1 Improved 2 Worse 3 OSA Category Kuna et al, under review More participants in than in actually had remission in Obstructive Sleep Apnea at year % Remission Remission of OSA, AHI < 5 events/h Kuna et al, under review 15
16 Other Areas of Interest Include: Malignancies Cognitive Impairment, Alzheimer s Disease Mobility, falls, physical function Multiple other problems of aging: diabetic micro and macro vascular complications, depression, bone density and fractures, body composition and sarcopenia The Look AHEAD of Tomorrow (at least through 215) intervention has been discontinued. In its place, everyone is being offered group meetings during the year. 6 month phone interviews will continue. Annual Exams will continue. Further follow up beyond August 213 is being planned and funding applied for. Look AHEAD has Succeeded as a Clinical Trial Extremely high retention: 89% of original subjects Excellent adherence to the protocol Sustained weight loss in group Complete data set with numerous outcomes Together, these factors allowed us to answer many questions regarding diabetes and obesity CVD, sleep apnea, cancer, kidney disease, fractures, mental health, mobility, quality of life 16
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