Changes in fat mass and lean body mass and outcomes in type 2 diabetes mellitus.

Previous studies have found that fat mass and lean body mass may act differently on the prognosis in patients type 2 diabetes mellitus (T2DM). However, the change of fat mass and lean body mass on prognosis in T2DM patients has not yet been investigated. We performed a Post hoc analysis of data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. Cox proportional hazards models were used to study the relationship between tertiles of the change trend in lean body mass index (LBMI, kg/m2/year) or fat mass index (FMI, kg/m2/year) and major cardiovascular adverse events (MACEs) and all cause mortality. Nine thousand, one hundred seventy-six T2DM patients with a mean follow-up of 9.52 ± 1.89 years were included in our study. The mean change in FMI per year was 0.10 ± 0.48 kg/m2. The mean change in LBMI per year was 0.05 ± 0.38 kg/m2. Normal weight patients had highest FMI/LBMI change; severely obese patients had lowest FMI/LBMI change. A U-shaped relationship was found between the change in FMI/LBMI and all cause mortality. A flat U-shaped relationship was also noted between the change in FMI or LBMI and MACEs. Compared with the second tertile, the first and third tertiles of the change in FMI (HR: 1.18, 95% CI 1.03-1.36; HR: 1.34, 95% CI 1.16-1.54, respectively)/LBMI (HR: 1.24, 95% CI 1.08-1.43; HR: 1.30, 95% CI 1.12-1.50, respectively) had higher all cause mortality; the third tertile of the change in FMI/LBMI showed a marginal increase of MACEs (HR: 1.15, 95% CI 1.01-1.32; HR: 1.17, 95% CI 1.02-1.33, respectively); sensitivity analysis and subgroup analysis showed these associations were not robust. Both lower and larger change in FMI or LBMI are associated with increased all cause mortality compared with the median change among patients with T2DM. Further study is needed to determine whether increased FMI or LBMI increases the risk of MACEs.Trial registration: clinicaltrials.gov., No. NCT00000620.