An interventional study of Passive heating and Thermoneutral in Diabetes Mellitus, Type 2 and Insulin Resistance, sponsored by University of Pecs. Withdrawn at 1 site in Hungary. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by University of Pecs · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
Patients will be randomized to receive whole-body passive heating via 38°C natural thermal mineral water baths.
Procedure: Passive heating
Patients randomized to the comparator group will dip in thermoneutral natural thermal mineral water (30-32°C).
Procedure: Thermoneutral
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.
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.
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
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.
Time frame: 4,8, and 12-weeks
Change in heart output
Absolute change from baseline to follow-up in heart output.
Time frame: 4,8, and 12-weeks
Change in the prevalence of electrocardiogram events
Change in the prevalence of electrocardiogram events from baseline to follow-up. Electrocardiogram events represent a composite endpoint of any new events detected using a 12 lead electrocardiogram (e.g., myocardial infarction, atrial fibrillation, atrioventricular block, etc.).
Time frame: 4,8, and 12-weeks
Change in the proportion of hypertension
Absolute change from baseline to follow-up in the proportion of hypertension
Time frame: 4,8, and 12-weeks
Change in the proportion of retinopathy
Absolute change from baseline to follow-up in the proportion of retinopathy
Time frame: 4,8, and 12-weeks
Change in the proportion of nephropathy
Absolute change from baseline to follow-up in the proportion of nephropathy
Time frame: 4,8, and 12-weeks
Change in the proportion of neuropathy
Absolute change from baseline to follow-up in the proportion of neuropathy
Time frame: 4,8, and 12-weeks
Change in total cholesterol level
Absolute change from baseline to follow-up in total cholesterol level.
Time frame: 4,8, and 12-weeks
Change in low-density lipoprotein cholesterol level
Absolute change from baseline to follow-up in low-density lipoprotein cholesterol level.
Time frame: 4,8, and 12-weeks
Change in high-density lipoprotein cholesterol level
Absolute change from baseline to follow-up in high-density lipoprotein cholesterol level.
Time frame: 4,8, and 12-weeks
Change in triglyceride level
Absolute change from baseline to follow-up in triglyceride level.
Time frame: 4,8, and 12-weeks
Change in alkaline phosphatase (ALP)
Absolute change from baseline to follow-up in alkaline phosphatase (ALP).
Time frame: 4,8, and 12-weeks
Change in alanine transaminase (ALT)
Absolute change from baseline to follow-up in alanine transaminase (ALT).
Time frame: 4,8, and 12-weeks
Change in aspartate transaminase (AST)
Absolute change from baseline to follow-up in aspartate transaminase (AST).
Time frame: 4,8, and 12-weeks
Change in gamma-glutamyl transferase (GGT).
Absolute change from baseline to follow-up in gamma-glutamyl transferase (GGT).
Time frame: 4,8, and 12-weeks
Change in glomerular filtration rate
Absolute change from baseline to follow-up in glomerular filtration rate.
Time frame: 4,8, and 12-weeks
Change in creatinine level
Absolute change from baseline to follow-up in creatinine.
Time frame: 4,8, and 12-weeks
Change in thrombocyte aggregation
Absolute change from baseline to follow-up in thrombocyte aggregation.
Time frame: 4,8, and 12-weeks
Heat Shock Protein expression
Difference between the two groups in the level of protein expression using flow cytometry.
Time frame: 4,8, and 12-weeks
Insulin signaling in polymorphonuclear cells
Difference between the two groups in the level of protein expression using flow cytometry.
Time frame: 4,8, and 12-weeks
Lipidom of polymorphonuclear cells
High sensitivity shotgun mass spectrometry will be used to characterize the lipidome of plasma, and polymorphonuclear blood cells.
Time frame: 4,8, and 12-weeks
Lipidom of plasma cells
High sensitivity shotgun mass spectrometry will be used to characterize the lipidome of plasma, and polymorphonuclear blood cells.
Time frame: 4,8, and 12-weeks
Change in obstructive sleep apnea proportion
Change in the proportion of obstructive sleep apnea from baseline to follow-up
Time frame: 4,8, and 12-weeks
Change in the proportion of abnormal overnight pulse oximetry
Absolute change from baseline to follow-up in the proportion of abnormal overnight pulse oximetry.
Time frame: 4,8, and 12-weeks
Change in 24-hour blood pressure
Absolute change from baseline to follow-up in 24-hour blood pressure
Time frame: 4,8, and 12-weeks
Plan to share: No
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