Heat Therapy in Patients With Type 2 Diabetes Mellitus (NCT05237219) | Clinical Trial Compass
WithdrawnNot Applicable
Heat Therapy in Patients With Type 2 Diabetes Mellitus
Stopped: The human resources required to start enrollment were not available anymore.
Hungary0Started 2022-05-01
Plain-language summary
Type 2 diabetes mellitus (T2DM) is a significant burden worldwide. In addition to lifestyle intervention, heat therapy has been shown to be effective in improving glycemic control. To date, there are no randomized, controlled trials investigating the efficacy of heat therapy in T2DM. Our aim is to investigate whether heat therapy with natural mineral water can improve blood glucose status in T2DM patients.
The HEATED study is a two-arm, randomized, controlled study. Patients with T2DM were randomly assigned to Group A (bath in 38 ° C natural thermal mineral water) or Group B (bath in thermoneutral water - 30-32 ° C). Both groups participate in up to five interventions per week, representing 50 to 60 heat therapies over the 12-week study. Each intervention lasts 30 minutes, preceded by a medical examination.
Who can participate
Age range
35 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patient with type 2 diabetes diagnosed according to the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) guidelines
* serum glycated hemoglobin (HbA1c) level between 7 and 10% (53-86 mmol/mol)
* signed written informed consent form
Exclusion Criteria:
* other types of diabetes mellitus
* patients with poor glycaemic control or unstable diabetes
* patients with known serious comorbidity and/ or with advanced macrovascular complications
* active bacterial infection or treatment with antibiotics within 3 weeks
* open wounds or skin lesions
* history of skin-related conditions or sensitivity to prolonged water immersion or exposure to pool chemicals
* severe psychiatric pathology or psychosis
* pregnancy or breastfeeding
* judgment by medical provider that heat therapy/ hydrotherapy poses an undue burden or risk
* participating in other ongoing clinical trials
* heat or balneotherapy in the past 3 months
* morbid obesity (body mass index \> 40 kg/m2)
* steroid treatment
* active autoimmune diseases
* coronavirus disease 2019 (COVID-19) in the past 3 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.