Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes

The Look AHEAD Research Group. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med2013;369(2):145-154. Available here

No reduction in the composite cardiovascular (CV) primary outcome of first occurrence of death from CV causes, nonfatal myocardial infarction (MI), nonfatal stroke, or hospitalization for angina, was seen with intensive lifestyle intervention in the Look AHEAD study.

Primary outcome
There were 403 events in the intensive lifestyle intervention group (1.83/100 person-years) vs 418 events (1.92/100 person-years) in the diabetes support and education group (control; hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.83-1.09; P=0.51). No significant differences were seen when the primary outcome was examined by subgroups, which included baseline cardiovascular disease (CVD), sex, and race/ethnic group.

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Look AHEAD: No Reduction in CV Events with Lifestyle Changes   
 

Secondary CV outcomes
No reduction was seen in the intensive lifestyle intervention group vs the control group, respectively:

  • Death from CV causes, nonfatal MI, or nonfatal stroke: 267 events (1.17/100 person-years) vs 283 events (1.25/100 person-years); HR, 0.93; 95% CI, 0.79-1.10; P=0.42.
  • Death from any cause, nonfatal MI, or nonfatal stroke: 496 events (2.25/100 person-years) vs 529 events (2.43/100 person-years); HR, 0.93; 95% CI, 0.82-1.05; P=0.23.
  • Death from any cause, nonfatal MI, nonfatal stroke, hospitalization for angina, coronary artery bypass grafting; percutaneous coronary intervention, hospitalization for heart failure, carotid endarterectomy, or peripheral vascular disease: 577 events (2.67/100 person-years) vs 600 events (2.81/100 person-years); HR, 0.94; 95% CI, 0.84-1.05; P=0.29.

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Look AHEAD: No Reduction in Secondary CV Outcomes with Lifestyle Changes   
  

Weight reduction
Greater weight reduction was seen among subjects assigned to intensive lifestyle intervention vs those assigned to control.

  • Largest differences seen at Year 1: 8.6% mean weight loss from baseline for intensive lifestyle intervention vs 0.7% for control
  • Study end: average weight loss from baseline 6.0% for intensive lifestyle intervention group vs 3.5% for control


In the intensive lifestyle intervention group, weight regain was seen through Year 5, followed by a subsequent gradual weight decrease. Gradual but consistent weight loss was seen throughout the trial in the control group.

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Look AHEAD: Greater Weight Reduction with Lifestyle Changes   
 

Improvement in A1C, CVD risk factors
When compared with the control group, subjects in the intensive lifestyle intervention group had:

  • Greater improvement in A1C, which was mostly seen during the first year but benefit was partly sustained throughout follow-up
  • Improvement in CVD risk factors, except LDL-C; improvement diminished over time
  • Greater improvement in fitness

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Look AHEAD: Lifestyle Changes Improve Glycemic Control, CV Risk Factors   
 


About Look AHEAD
Look AHEAD compared the effects of intensive lifestyle management with diabetes education on weight loss and CV outcomes among overweight/obese patients with type 2 diabetes.

Look AHEAD was stopped after median follow-up of 9.6 years due to futility. The study’s primary outcome was a composite of first occurrence of CV death, nonfatal MI, nonfatal stroke, and hospitalization for angina*.

Participant characteristics were similar between the intensive lifestyle intervention (n=2,570) and diabetes support and education (control; n=2,575) groups at baseline, with more subjects in the intensive lifestyle intervention group using statins, insulin, and antihypertensive therapy.
 

  • Average age: 58.7 yrs
  • 60% female
  • Mean body mass index (BMI): 36.0 kg/m2  
  • Median diabetes duration: 5 yrs
  • CVD history: 14% of subjects


*Added to primary outcome after 2 years of study due to lower than expected cardiovascular event rate in the control group.

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Look AHEAD: Primary Outcome, Participant Characteristics   
 
 
Look AHEAD=Action for Health in Diabetes
  

July 2013 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional/commercial interest.  

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Last Modified: 3/23/2015