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.

Background: Interventions capable of modulating the heat shock response (HSR), such as physical exercise and heat therapy (HT), are potential therapeutic strategies for the prevention and treatment of diabetes.

Objective: This study aims to evaluate the effects of resistance training (RT) and HT on HbA1c levels, metabolic and inflammatory profiles, gut microbiota, and HSR in patients with type 2 diabetes mellitus (T2DM).

Design and setting: A randomized, double-blind, parallel clinical trial will be conducted for 12 weeks in southern Brazil.

Methods: Participants with T2DM will be randomized into control (any intervention), RT, or HT groups. In the RT group, participants will perform supervised exercise, and the HT group will undergo whole-body heat treatment in an environmental chamber initially set at 55.0°C, both on three non-consecutive days of the week (60 min). Blood samples will be collected before and after 12 weeks of treatment. Heat shock response, body composition and physical fitness, glycemic control, lipid profile, gut microbiota composition and diversity, inflammatory markers, and flow-mediated dilation will be evaluated.

Conclusion: Since the HSR response is decreased in individuals with diabetes, we believe that improving the HSR may be important in preventing chronic complications associated with T2DM. This randomized clinical trial will determine the efficacy of HT compared to RT in improving HSR when combined with conventional therapy in individuals with T2DM. Multiple HT and RT effects may contribute to a lower mortality risk in these individuals.

Clinical trial registration: Unique Identifier NCT05847075. https://clinicaltrials.gov/study/NCT05847075.