Look AHEAD
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
40.0% male
N = 5145
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).
Primary outcome
Incidence of CV death, nonfatal MI, nonfatal stroke, or hospitalization for angina
1.83
1.92
1.9/100 py
1.4/100 py
1.0/100 py
0.5/100 py
0.0/100 py
An intensive lifestyle
intervention
Standard lifestyle
counseling
No significant
difference ↔
No significant difference in the incidence of CV death, nonfatal MI, 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 CV death, MI 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 CV death, nonfatal MI, 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.
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