The 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.The 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.The 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.ClinicalTrials.gov,
NCT05237219.
