Heat Therapy in Patients With Type 2 Diabetes Mellitus
Key facts
- Who runs it
- University of Pecs
- Where
- Hungary1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 1 May 2022
- Ended
- 1 Jun 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Passive heating
- Thermoneutral
- Record updated
- 20 April 2023
- Why it stopped
- The human resources required to start enrollment were not available anymore.
Who can take part
- Age
- 35 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- active bacterial infection or treatment with antibiotics within 3 weeks
- judgment by medical provider that heat therapy/ hydrotherapy poses an undue burden or risk
- steroid treatment
- other types of diabetes mellitus
- patients with poor glycaemic control or unstable diabetes
- history of skin-related conditions or sensitivity to prolonged water immersion or exposure to pool chemicals
- severe psychiatric pathology or psychosis
- active autoimmune diseases
- coronavirus disease 2019 (COVID-19) in the past 3 months
- patients with known serious comorbidity and/ or with advanced macrovascular complications
- open wounds or skin lesions
- pregnancy or breastfeeding
- participating in other ongoing clinical trials
- heat or balneotherapy in the past 3 months
- morbid obesity (body mass index > 40 kg/m2)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Passive heatingTreatment being tested
Patients will be randomized to receive whole-body passive heating via 38°C natural thermal mineral water baths.
- ThermoneutralExisting treatment, for comparison
Patients randomized to the comparator group will dip in thermoneutral natural thermal mineral water (30-32°C).
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of HEAT Therapy on patiEnts With Type 2 Diabetes Mellitus (HEATED): Protocol of a Randomized, Two-arm Controlled Trial
- Record updated
- 20 April 2023