Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial.

BACKGROUND Lifestyle interventions produce short-term improvements in glycemia and cardiovascular disease (CVD) risk factors in individuals with type 2 diabetes mellitus, but no long-term data are available. We examined the effects of lifestyle intervention on changes in weight, fitness, and CVD risk factors during a 4-year study. METHODS The Look AHEAD (Action for Health in Diabetes) trial is a multicenter randomized clinical trial comparing the effects of an intensive lifestyle intervention (ILI) and diabetes support and education (DSE; the control group) on the incidence of major CVD events in 5145 overweight or obese individuals (59.5% female; mean age, 58.7 years) with type 2 diabetes mellitus. More than 93% of participants provided outcomes data at each annual assessment. RESULTS Averaged across 4 years, ILI participants had a greater percentage of weight loss than DSE participants (-6.15% vs -0.88%; P < .001) and greater improvements in treadmill fitness (12.74% vs 1.96%; P < .001), hemoglobin A(1c) level (-0.36% vs -0.09%; P < .001), systolic (-5.33 vs -2.97 mm Hg; P < .001) and diastolic (-2.92 vs -2.48 mm Hg; P = .01) blood pressure, and levels of high-density lipoprotein cholesterol (3.67 vs 1.97 mg/dL; P < .001) and triglycerides (-25.56 vs -19.75 mg/dL; P < .001). Reductions in low-density lipoprotein cholesterol levels were greater in DSE than ILI participants (-11.27 vs -12.84 mg/dL; P = .009) owing to greater use of medications to lower lipid levels in the DSE group. At 4 years, ILI participants maintained greater improvements than DSE participants in weight, fitness, hemoglobin A(1c) levels, systolic blood pressure, and high-density lipoprotein cholesterol levels. CONCLUSIONS Intensive lifestyle intervention can produce sustained weight loss and improvements in fitness, glycemic control, and CVD risk factors in individuals with type 2 diabetes. Whether these differences in risk factors translate to reduction in CVD events will ultimately be addressed by the Look AHEAD trial. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00017953.

[1]  R. Levy,et al.  Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. , 1972, Clinical chemistry.

[2]  Claude Bouchard,et al.  Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. , 1998, WMJ : official publication of the State Medical Society of Wisconsin.

[3]  M. Stampfer,et al.  Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. , 2008, The New England journal of medicine.

[4]  R. Wing,et al.  Relative effects of calorie restriction and weight loss in noninsulin-dependent diabetes mellitus. , 1993, The Journal of clinical endocrinology and metabolism.

[5]  Mark A Pereira,et al.  Effect of a Lifestyle Intervention on Change in Cardiorespiratory Fitness in Adults with Type 2 Diabetes: Results from the Look AHEAD Study , 2008, International Journal of Obesity.

[6]  Pi-Sunyer Fx Short-Term Medical Benefits and Adverse Effects of Weight Loss , 1993 .

[7]  T. Wadden,et al.  Two-year changes in lipids and lipoproteins associated with the maintenance of a 5% to 10% reduction in initial weight: some findings and some questions. , 1999, Obesity research.

[8]  Neil R. Powe,et al.  Meta-Analysis: Glycosylated Hemoglobin and Cardiovascular Disease in Diabetes Mellitus , 2004, Annals of Internal Medicine.

[9]  J. Lindström,et al.  Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study , 2006, The Lancet.

[10]  Sodium reduction and weight loss in the treatment of hypertension in older persons: a randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). TONE Collaborative Research Group. , 1998, JAMA.

[11]  A. Avenell,et al.  Effects of weight loss in overweight/obese individuals and long‐term lipid outcomes – a systematic review , 2004, Obesity reviews : an official journal of the International Association for the Study of Obesity.

[12]  R R Wing,et al.  Long-term effects of modest weight loss in type II diabetic patients. , 1987, Archives of internal medicine.

[13]  Claude Bouchard,et al.  Effects of bariatric surgery on mortality in Swedish obese subjects. , 2007, The New England journal of medicine.

[14]  S. Blair,et al.  Cardiorespiratory fitness and body mass index as predictors of cardiovascular disease mortality among men with diabetes. , 2005, Archives of internal medicine.

[15]  B. Swinburn,et al.  Long-term effects of a reduced fat diet intervention on cardiovascular disease risk factors in individuals with glucose intolerance. , 2004, Diabetes research and clinical practice.

[16]  R. Porter,et al.  Clinical practice recommendations for bipolar disorder , 2009, Acta psychiatrica Scandinavica. Supplementum.

[17]  R. Wing,et al.  Comparison of obese NIDDM and nondiabetic women: short- and long-term weight loss. , 1995, Obesity research.

[18]  S. Fowler,et al.  Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. , 2002 .

[19]  M. Flechtner-Mors,et al.  Metabolic and weight-loss effects of a long-term dietary intervention in obese patients. , 1999, The American journal of clinical nutrition.

[20]  The Diabetes Prevention Program (DPP): description of lifestyle intervention. , 2002, Diabetes care.

[21]  T. Wadden,et al.  One‐year Weight Losses in the Look AHEAD Study: Factors Associated With Success , 2009, Obesity.

[22]  T. Wadden,et al.  The Look AHEAD Study: A Description of the Lifestyle Intervention and the Evidence Supporting It , 2006, Obesity.

[23]  S. Blair,et al.  Cardiorespiratory fitness, body composition, and all-cause and cardiovascular disease mortality in men. , 1999, The American journal of clinical nutrition.

[24]  R. Sigal,et al.  Meta-analysis of the effect of structured exercise training on cardiorespiratory fitness in Type 2 diabetes mellitus , 2003, Diabetologia.

[25]  T. Wilt,et al.  Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. , 1999, The New England journal of medicine.

[26]  George A. Bray,et al.  Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in Diabetes) study , 2006, Diabetes & vascular disease research.

[27]  U. Siering,et al.  Long-term Effects of Weight-Reducing Interventions in Hypertensive Patients: Systematic Review and Meta-analysis , 2009 .

[28]  M. Uusitupa,et al.  Habitual physical activity, aerobic capacity and metabolic control in patients with newly-diagnosed Type 2 (non-insulin-dependent) diabetes mellitus: effect of 1-year diet and exercise intervention , 1992, Diabetologia.

[29]  S. Blair,et al.  Cardiorespiratory fitness attenuates the effects of the metabolic syndrome on all-cause and cardiovascular disease mortality in men. , 2004, Archives of internal medicine.

[30]  R. Wing,et al.  Effect of modest weight loss on changes in cardiovascular risk factors: are there differences between men and women or between weight loss and maintenance? , 1995, International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity.

[31]  Ian Janssen,et al.  Metabolic syndrome, obesity, and mortality: impact of cardiorespiratory fitness. , 2005, Diabetes care.

[32]  L. Epstein,et al.  Exercise in a behavioural weight control programme for obese patients with Type 2 (non-insulin-dependent) diabetes , 1988, Diabetologia.

[33]  E. Barrett-Connor,et al.  Sex Differences in Diabetes Risk and the Effect of Intensive Lifestyle Modification in the Diabetes Prevention Program , 2008, Diabetes Care.

[34]  D. Nieman,et al.  Comparison of Weight-Loss Diets with Different Compositions of Fat, Protein, and Carbohydrates , 2010 .

[35]  Matthew D. Davis,et al.  Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. , 2000, The New England journal of medicine.

[36]  Meghan L Butryn,et al.  Efficacy of lifestyle modification for long-term weight control. , 2004, Obesity research.

[37]  T. Valle,et al.  Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. , 2001, The New England journal of medicine.

[38]  M. Butryn,et al.  Behavioral approaches to the treatment of obesity. , 2012 .

[39]  Karen C Johnson,et al.  Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes. , 2003, Controlled clinical trials.

[40]  B. Howard,et al.  Effects of Diet and Exercise in Preventing NIDDM in People With Impaired Glucose Tolerance: The Da Qing IGT and Diabetes Study , 1997, Diabetes Care.

[41]  R. Hanson,et al.  Changes in BMI and weight before and after the development of type 2 diabetes. , 2001, Diabetes care.

[42]  J. Leahy,et al.  Improvements in Diabetes Processes of Care and Intermediate Outcomes: United States, 1988–2002Saaddine JB, Cadwell B, Gregg EW, et al (Centers for Disease Control and Prevention, Atlanta, Ga) Ann Intern Med 144:465–474, 2006§ , 2007 .

[43]  D. Levy,et al.  Impact of high-normal blood pressure on the risk of cardiovascular disease. , 2002, The New England journal of medicine.

[44]  G. Bray,et al.  Reduction in Weight and Cardiovascular Disease Risk Factors in Individuals With Type 2 Diabetes , 2007, Diabetes Care.

[45]  W L Haskell,et al.  Effects of diet and exercise in men and postmenopausal women with low levels of HDL cholesterol and high levels of LDL cholesterol. , 1998, The New England journal of medicine.

[46]  J. Olefsky,et al.  Glycemic effects of intensive caloric restriction and isocaloric refeeding in noninsulin-dependent diabetes mellitus. , 1985, The Journal of clinical endocrinology and metabolism.

[47]  Claude Bouchard,et al.  Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. , 2004, The New England journal of medicine.

[48]  The effects on plasma lipoproteins of a prudent weight-reducing diet, with or without exercise, in overweight men and women. , 1991 .

[49]  J. Huttunen,et al.  Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. Safety of treatment, changes in risk factors, and incidence of coronary heart disease. , 1987, The New England journal of medicine.

[50]  S. Anton,et al.  Preventing Weight Regain After Weight Loss , 2003 .