Effect of HEAT therapy in patiEnts with type 2 Diabetes mellitus (HEATED): protocol for a randomised controlled trial

Abstract

IntroductionThe burden of type 2 diabetes mellitus (T2DM) is increasing worldwide. Heat therapy has been found effective in improving glycaemic control. However, to date, there is a lack of randomised controlled studies investigating the efficacy of heat therapy in T2DM. Therefore, we aim to investigate whether heat therapy with natural thermal mineral water can improve glycaemic control in patients with T2DM.Methods and analysisThe HEAT therapy in patiEnts with type 2 Diabetes mellitus (HEATED) Study is a single-centre, two-arm randomised controlled trial being conducted at Harkány Thermal Rehabilitation Centre in Hungary. Patients with T2DM will be randomly assigned to group A (bath sessions in 38°C natural thermal mineral water) and group B (baths in thermoneutral water (30°C–32°C)). Both groups will complete a maximum of 5 weekly visits, averaging 50–60 visits over the 12-week study. Each session will last 30 min, with a physical check-up before the bath. At baseline, patients’ T2DM status will be investigated thoroughly. Possible microvascular and macrovascular complications of T2DM will be assessed with physical and laboratory examinations. The short form-36 questionnaire will assess the quality of life. Patients will also be evaluated at weeks 4, 8 and 12. The primary endpoint will be the change of glycated haemoglobin from baseline to week 12. An estimated 65 patients will be enrolled per group, with a sample size re-estimation at the enrolment of 50% of the calculated sample size.Ethics and disseminationThe study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (818-2/2022/EÜIG). Written informed consent is required from all participants. We will disseminate our results to the medical community and will publish our results in peer-reviewed journals.Trial registration numberClinicalTrials.gov, NCT05237219.

Nitric Oxide as a Novel Biomarker for Monitoring Heat Exposure Responses in High Glucose- maintained Keratinocytes

“…Thus, proposing NO pathway as one molecular mechanism via which heat exposure may influence the responses of keratinocytes in high glucose condition. As recently proposed in clinical studies, the duration of heat exposure is a key when investigating its therapeutic effect on diabetes [16][17][18][19]. Given this and our results indicating the altered NO production upon acute heat exposure, we aimed to explore how longer heat exposure, referred as to the chronic exposure, may influence its levels.…”

“…Recently, clinical studies reported that heat therapy has beneficial results in improving insulin sensitivity and glycemic control for diabetic patients [18,19,52,53]. Based on this, we aimed to explore whether frequent heat exposure may improve the levels of NO and consequently HSP-70 protein in high glucose-maintained keratinocytes.…”

“…Importantly, clinical studies claim the therapeutic effects of heat treatments on diabetes through controlling hyperglycemic level and reducing insulin resistance [16][17][18][19]. One proposed hypothesis is that heat can affect human sweating rate and the sweat composition.…”