Total energy expenditure is comparable between patients with and without diabetes mellitus: Clinical Evaluation of Energy Requirements in Patients with Diabetes Mellitus (CLEVER-DM) Study

Objective Assessment of total energy expenditure (TEE) is essential for appropriate recommendations regarding dietary intake and physical activity in patients with and without diabetes mellitus (DM). However, few reports have focused on TEE in patients with DM, particularly in Asian countries. Therefore, we evaluated TEE in Japanese patients with DM using the doubly labeled water (DLW) method and physical activity level (PAL). Research design and methods In this cross-sectional observational study, we evaluated 52 patients with type 2 DM and 15 patients without DM. Free-living TEE was measured over 12-16 days by the DLW method, and PAL was calculated as TEE divided by the basal metabolic rate (BMR) as assessed by indirect calorimetry. The equivalence margin was defined as 5 kcal/kg/day. Results The numbers of patients with DM treated with insulin, oral antidiabetic drugs, and diet were 18 (34.6%), 20 (38.5%), and 14 (26.9%), respectively. The mean±SD level of glycated hemoglobin was 6.9%±0.8% and 5.5%±0.3% in the DM and non-DM group, respectively (p<0.001). The mean body mass index was 23.3±3.0 and 22.7±2.1 kg/m 2 in the DM and non-DM group, respectively. The mean TEE per kilogram body weight adjusted for sex and age was 36.5 kcal/kg/day and 37.5 kcal/kg/day in the DM and non-DM group, respectively, with no significant difference (mean difference,-1.0 kcal/kg/day; 95% CI-4.2 to 2.3 kcal/kg/day). The BMR tended to be higher in the DM than in the non-DM group (mean difference, 33 kcal/day; 95% CI,-15 to 80 kcal/day). The mean PAL adjusted for sex and age was 1.71 and 1.81 in the DM and non-DM group, respectively, without a significant difference (mean difference,-0.10; 95% CI-0.21 to 0.01). Conclusion TEE was comparable between Japanese patients with and without DM. Trial registration number UMIN000023051.