6/28/23, 11:02 PM Look AHEAD Pathway Feedback Search Clinical Topics Home Studies Look AHEAD Look AHEAD Disease Disease Diabetes mellitus type 2 Obesity Trial question What is the role of intensive lifestyle intervention in patients with T2DM who are overweight or obese? Study design Multi-center Open label RCT Population Characteristics of study participants 60.0% female N = 5145 40.0% male 5145 patients (3063 female, 2082 male) Inclusion criteria: patients with T2DM who are overweight or obese Key exclusion criteria: schizophrenia or other psychotic disorders, hospitalization for depression in the past six months, alcohol or substance abuse within the past 12 months, use of medications for weight loss, history of bariatric surgery, or pregnancy or nursing Interventions N=2570 an intensive lifestyle intervention (promoted weight loss through decreased caloric intake and increased physical activity) N=2575 standard lifestyle counseling (diabetes support and education) https://web.pathway.md/studies/recKSl80uu11sHzd2 1/2 6/28/23, 11:02 PM Look AHEAD Pathway Primary outcome Incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina 1.9/100 py 1.92 1.83 1.4/100 py 1.0/100 py 0.5/100 py No significant difference 0.0/100 py An intensive lifestyle intervention Standard lifestyle counseling No significant difference in the incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina (1.83 /100 py vs. 1.92 /100 py; HR 0.95, 95% CI 0.83 to 1.09) Secondary outcomes No significant difference in the incidence of cardiovascular death, myocardial infarction or stroke (1.17 /100 py vs. 1.25 /100 py; HR 0.93, 95% CI 0.79 to 1.1) No significant difference in all cause death (0.73 vs. 0.86; HR 0.85, 95% CI 0.69 to 1.04) Safety outcomes No significant differences in severe hypoglycemia, gallstones, amputations, adjudicated fractures, and congestive HF. Significant differences in self-reported fractures (2.51 vs. 2.16 events per 100 person-years, p = 0.01). Conclusion In patients with T2DM who are overweight or obese, an intensive lifestyle intervention was not superior to standard lifestyle counseling with respect to the incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina. Reference Look AHEAD Research Group, Wing RR, Bolin P et al. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. Open reference URL https://web.pathway.md/studies/recKSl80uu11sHzd2 2/2