NCT05237219 - Heat Therapy in Patients With Type 2 Diabetes Mellitus | Crick

Overview

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.

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. The study aims 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 will be 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 will participate in up to five interventions per week, representing 50 to 60 heat therapies over the 12-week study. Each intervention will last 30 minutes, preceded by a medical examination. At baseline, patients' T2DM status will be recorded and possible micro- and macrovascular complications of T2DM are assessed by physical and laboratory tests. In addition, sensory and autonomic neuropathy will be assessed using Neurometer, Neuropad, and 128 Hz tuning fork tests. Quality of life will be assessed using the SF-36 questionnaire. In addition to baseline, patient data will be recorded at 4, 8, and 12 weeks. During routine blood collection, biobank storage will be performed via plus blood samples collection. The primary endpoint will be the change from baseline in glycated hemoglobin by week 12 in both groups. Based on a preliminary estimate of the number of items, 65 patients per group are planned to be included in the HEATED study. The results of the study described above may provide information on the utility of heat therapy in type 2 diabetics. Using the samples stored in the biobank, further analyzes will be performed at the end of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Diabetes Mellitus, Type 2 Insulin Resistance

Interventions

Passive heatingPROCEDURE

Patients will perform baths in 38°C natural thermal mineral water a maximum of five times per week, over a 12-week period. This will result in a maximum of 60 visits. Each visit will take a maximum of 30 minutes with a physical check-up before and after the bath.

ThermoneutralPROCEDURE

Patients will perform baths in 30-32°C natural thermal mineral water a maximum of five times per week, over a 12-week period. This will result in a maximum of 60 visits. Each visit will take a maximum of 30 minutes with a physical check-up before and after the bath.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute for Translational Medicine, University of Pécs

Pécs, Hungary

Outcomes

Primary Outcomes

Change in hemoglobin A1c level

The absolut changes in the hemoglobin A1c from baseline to 12-weeks between the two groups will be compared.

Time frame: 12 weeks

Secondary Outcomes

Change in hemoglobin A1c level

Absolute change from baseline to follow-up in hemoglobin A1c level.

Time frame: 4 and 8 weeks

Change in fasting plasma glucose

Absolute change from baseline to follow-up in fasting plasma glucose.

Time frame: 4,8, and 12-weeks

Change in fasting insulin

Absolute change from baseline to follow-up in fasting insulin.

Time frame: 4,8, and 12-weeks

Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Absolute change from baseline to follow-up in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).

Time frame: 4,8, and 12-weeks

Decrease of daily insulin dose

Absolute change from baseline to follow-up of the daily insulin dose.

Time frame: 4,8, and 12-weeks

Change in body mass index

Absolute change from baseline to follow-up in body mass index. Weight and height will be combined to report BMI in kg/m\^2.

Time frame: 4,8, and 12-weeks

Change in mean blood pressure

Absolute change from baseline to follow-up in mean blood pressure.