Effect of heat therapy compared with strength training on metabolic profile, heat shock response, inflammation, cardiovascular responses and microbiota in individuals with type 2 diabetes: Study protocol of a randomized trial

Abstract

Abstract Background: Heat shock response (HSR) is blocked in diabetes, but can be partially restored by resistance training. Some people have difficulties in performing physical exercise, therefore, an alternative therapy is heat therapy (HT). Interventions capable of modulating HSR, such as physical exercise and heat therapy, are candidates as therapeutic strategies combined in the prevention and treatment of diabetes. This study aims to evaluate the effect of resistance training (RT) and HT in type 2 diabetes mellitus (T2DM) on HbA1c levels, metabolic and inflammatory profile, gut microbiota, and HSR. Methods: A randomized, double-blind, parallel clinical trial will be conducted for 12 weeks. Participants with T2DM will be randomized into intervention groups Control (C), RT or HT. In the control group, participants will not receive any intervention. In the intervention group RT, participants will perform supervised exercise (~60 min) on three non-consecutive days of the week. Participants in the HT group will undertake whole body heat treatment in an environmental chamber initially set at 55.0oC on three non-consecutive days of the week (60 min). Blood samples will be collected before and after 12 weeks of treatment, to evaluate heat shock response, body composition and physical fitness, glycemic control, lipid profile, gut microbiota composition and diversity, inflammatory markers and flow mediated dilation. Discussion: Since HSR response is decreased in individuals with diabetes, we believe that improving HSR may be important to prevent chronic complications associated with T2DM. This randomized clinical trial will determine the efficacy of HT compared to RT for improving HR when added to conventional therapy in individuals with T2DM. The multiple HT and RT effects might contribute to lower mortality risk in these individuals. Our study is the first to evaluate the efficacy of HT and RT, for 12 weeks, in glucose, lipid and inflammatory profile, microbiota, and HR in individuals with T2DM. Moreover, we will maintain the experimental protocol for 12 weeks, which is the time necessary to obtain changes in the main parameter of diabetes control, HbA1c. Trial registration: NCT05847075. Registered on ClinicalTrials.gov, 05/06/23.