Abstract
BACKGROUND: We assessed the effect of supervised, combined aerobic and resistance exercise on diabetic parameters in Japanese patients with type 2 diabetes mellitus (T2DM). METHODS: This 12-week, multicenter (17 medical institutions), open-label, parallel-group study (clinicaltrials.jp; JapicCTI-184002), randomized (1:1) Japanese patients aged 20-75 years with T2DM and hemoglobin A1c (HbA1c) of 7.0-10.0% to supervised exercise (n = 113) or standard therapy (n = 115). The supervised exercise group undertook supervised aerobic (30 min) and resistance exercise 3 times/week (20 designated gyms). Primary endpoint was change in HbA1c from baseline at week 13. Secondary endpoints were change in fasting blood glucose (FBG), glycoalbumin, fasting insulin, homeostatic model assessment of insulin resistance (HOMA-IR), and HOMA-β at week 13. RESULTS: Of 228 randomized patients, 97 (85.8%) in the supervised exercise group and 108 (93.9%) in the standard therapy group completed the study. Supervised exercise significantly lowered HbA1c at week 13 versus standard therapy (estimated difference in change from baseline [95% confidence interval]: - 0.44% [- 0.61, - 0.28], p < 0.001). Supervised exercise also significantly decreased FBG (estimated difference: - 13.0 [- 19.2, - 6.7] mg/dL) and glycoalbumin (estimated difference: - 1.52% [- 2.10, - 0.93]) compared with standard therapy. Fasting insulin (- 0.5 µIU/mL) and HOMA-IR (- 0.3) decreased with supervised exercise, but group differences were not significant. Treatment-emergent adverse events were more frequent in the supervised exercise group (42.5%) than in the standard therapy group (29.6%); however, no major safety concerns were identified. CONCLUSIONS: A structured, supervised, aerobic and resistance exercise program improved HbA1c and was well accepted among patients with T2DM. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13340-021-00506-5.