A secondary analysis of clinical trial data found that an intensive lifestyle intervention with sustained weight loss may help reduce cardiovascular risk among patients with type 2 diabetes (T2D) who are overweight or obese. These findings were published in eClinicalMedicine.
In this analysis, data from the Look AHEAD (Clinictrails.gov identifier: NCT00017953) study, which was a multicenter, randomized controlled clinical trial, were analyzed. Patients (N=4312) with T2D who were overweight or obese were randomly assigned to receive either intensive lifestyle intervention (ILI) with a goal of 7% or more body weight loss (n=2194) or diabetes support and education (n=2118). Patients were stratified by the time in range (TIR) of their weight loss goal. Cardiovascular outcomes of patients with TIR 0% (n=727), greater than 0% to 50% (n=656), and greater than 50% (n=811) were compared with the diabetes support and education (DSE) cohort using a propensity score matching approach.
Patient cohorts were well balanced. Patients were aged mean 57.9 to 59.8 years, 53.9% to 62.7% were women, and BMI was 35.6 to 36.5 at baseline.
During a median follow-up of 9.5 years, the primary composite outcome of death from cardiovascular causes, nonfatal myocardial infarction (MI), nonfatal stroke, or hospitalization for angina occurred among 352 ILI and 342 DSE participants. No significant group differences in the primary outcome were observed (hazard ratio [HR], 0.99; 95% CI, 0.85-1.15; P =.883).
Stratified by TIR, incidence rates of the primary outcome decreased progressively from 19.5% among the 0% group to 18.9% among the greater than 0% to 50% group and 14.5% among the greater than 50% group compared with 15.7%, 15.6%, and 19.5% in the matched DSE groups, respectively.
Compared with the matched controls, the greater than 50% group was associated with decreased risk for the primary outcome (adjusted HR [aHR], 0.55; 95% CI, 0.40-0.76; P <.001); death from cardiovascular causes, nonfatal MI, or nonfatal stroke (aHR, 0.41; 95% CI, 0.28-0.61; P <.001); death from any cause, nonfatal MI, nonfatal stroke, or hospitalization for angina (aHR, 0.56; 95% CI, 0.42-0.74; P <.001); and death from any cause, nonfatal MI, nonfatal stroke, hospitalization for angina, coronary-artery bypass grafting, percutaneous coronary intervention, hospital admission for heart failure, carotid endarterectomy, or peripheral vascular disease (aHR, 0.60; 95% CI, 0.46-0.78; P <.001).
The 0% cohort was associated with increased risk for death from any cause, nonfatal MI, nonfatal stroke, hospitalization for angina, coronary artery bypass grafting, percutaneous coronary intervention, hospital admission for heart failure, carotid endarterectomy, or peripheral vascular disease (aHR, 1.27; 95% CI, 1.01-1.59; P =.038).
Similar results were observed in a sensitivity analysis when the control group was also stratified by TIR.
This study may have included some selection bias as the ability to maintain weight loss after the study intervention may have been influenced by psychological or social factors.
“…among adults with overweight [or] obesity and type 2 diabetes, cardiovascular effects of ILI are not apparent if they have TIR of 0% to 50%, whereas those with TIR of greater than 50% to 100% are at significantly lower risk of cardiovascular events compared with the matched participants who undergo DSE,” the study authors wrote. “These findings provided the new evidence for the recommendations contained in the current guidelines and emphasized the importance of maintaining the lower body weight after achieving weight loss through improvements in diet and physical activity.”
Liu M, Huang R, Xu L, et al. Cardiovascular effects of intensive lifestyle intervention in adults with overweight/obesity and type 2 diabetes according to body weight time in range. eClinicalMedicine. Published online May 26, 2022. doi:10.1016/j.eclinm.2022.101451