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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
  1. Katsutaro Morino1,
  2. Keiko Kondo2,
  3. Shigeho Tanaka3,
  4. Yuki Nishida3,
  5. Satoshi Nakae3,
  6. Yosuke Yamada3,
  7. Satoshi Ugi1,
  8. Keiko Fuse2,
  9. Itsuko Miyazawa1,
  10. Akiko Ohi4,
  11. Kaori Nishida4,
  12. Mika Kurihara4,
  13. Masaya Sasaki4,
  14. Naoyuki Ebine5,
  15. Satoshi Sasaki6,
  16. Fuminori Katsukawa7,
  17. Hiroshi Maegawa1
  18. On behalf of the CLEVER-DM Study research group
  1. 1Department of Medicine, Shiga University of Medical Science, Otsu, Japan
  2. 2Department of Public Health, Shiga University of Medical Science, Otsu, Japan
  3. 3Department of Nutrition and Metabolism, National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, Tokyo, Japan
  4. 4Division of Clinical Nutrition, Shiga University of Medical Science, Otsu, Japan
  5. 5Faculty of Health and Sports Science, Doshisha University, Kyotanabe, Japan
  6. 6Department of Social and Preventive Epidemiology, The University of Tokyo, Tokyo, Japan
  7. 7Sports Medicine Research Center, Keio University, Yokohama, Japan
  1. Correspondence to Dr Katsutaro Morino; morino{at}


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/m2 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.

  • energy expenditure
  • physical activity
  • type 2 diabetes

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  • Presented at Parts of this study were presented in abstract form at the 78th Scientific Sessions of the American Diabetes Association, Orlando, Florida, June 22–26, 2018.

  • Collaborators A complete list of the members of the CLEVER-DM Study is provided in online supplementary information 2. The authors also thank Keiko Kosaka, Eriko Naiki, Chikako Ikeuchi, Takako Fujii, Noriko Yamamoto, Kaori Nagano, Mayumi Yotsushika, Mai Nakaizumi, Akiko Sakata, and Hiroko Kogure for their expert technical assistance. Finally, the authors thank Angela Morben, DVM, ELS, from Edanz Group (, for editing the English text of a draft of this manuscript.

  • Contributors KM and KK contributed to the planning and conduct of the study, and drafted and revised the manuscript. ST contributed to the planning of the study and revised the manuscript. AO, KN, MK, KF, and IM contributed to the conduct of the study. YN, SN, YY, SU, MS, FK, HM, and NE contributed to the planning of the study and revised the manuscript. NE and SS contributed to the planning of the study. All authors read and approved the final manuscript.

  • Funding This study was funded by AMED under Grant Numbers JP17ek0210045 and JP18ek0210112. This study was also supported in part by the Japan Foundation for Applied Enzymology (to KK).

  • Competing interests ST received consigned research funds from Omron Healthcare. The remaining authors declare no competing interests.

  • Patient consent for publication Not required.

  • Ethics approval The study was performed in accordance with the principles contained within the Declaration of Helsinki. The protocol was approved by the ethics committee of Keio University (Protocol No 2015–03), National Institutes of Biomedical Innovation, Health and Nutrition (Protocol No 29), and Shiga University of Medical Science (Protocol No 28–062).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data are available upon reasonable request.