Heat Therapy in Patients With Type 2 Diabetes Mellitus

Not Applicable

Withdrawn

• Conditions: Insulin Resistance; Diabetes Mellitus, Type 2
• Interventions: Procedure: Passive heating; Procedure: Thermoneutral

• Registration Number: NCT05237219
• Lead Sponsor: University of Pecs

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-14
• Study Start: 2022-05-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20
• Primary Completion: 2024-01-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passive heating	Passive heating	Patients will be randomized to receive whole-body passive heating via 38°C natural thermal mineral water baths.
Thermoneutral	Thermoneutral	Patients randomized to the comparator group will dip in thermoneutral natural thermal mineral water (30-32°C).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in mean blood pressure	4,8, and 12-weeks	Absolute change from baseline to follow-up in mean blood pressure.
Change in the proportion of nephropathy	4,8, and 12-weeks	Absolute change from baseline to follow-up in the proportion of nephropathy
Change in total cholesterol level	4,8, and 12-weeks	Absolute change from baseline to follow-up in total cholesterol level.
Change in low-density lipoprotein cholesterol level	4,8, and 12-weeks	Absolute change from baseline to follow-up in low-density lipoprotein cholesterol level.
Change in hemoglobin A1c level	4 and 8 weeks	Absolute change from baseline to follow-up in hemoglobin A1c level.
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	4,8, and 12-weeks	Absolute change from baseline to follow-up in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Change in body mass index	4,8, and 12-weeks	Absolute change from baseline to follow-up in body mass index. Weight and height will be combined to report BMI in kg/m\^2.
Change in the proportion of retinopathy	4,8, and 12-weeks	Absolute change from baseline to follow-up in the proportion of retinopathy
Change in triglyceride level	4,8, and 12-weeks	Absolute change from baseline to follow-up in triglyceride level.
Change in creatinine level	4,8, and 12-weeks	Absolute change from baseline to follow-up in creatinine.
Insulin signaling in polymorphonuclear cells	4,8, and 12-weeks	Difference between the two groups in the level of protein expression using flow cytometry.
Heat Shock Protein expression	4,8, and 12-weeks	Difference between the two groups in the level of protein expression using flow cytometry.
Change in fasting plasma glucose	4,8, and 12-weeks	Absolute change from baseline to follow-up in fasting plasma glucose.
Change in the proportion of hypertension	4,8, and 12-weeks	Absolute change from baseline to follow-up in the proportion of hypertension
Change in alkaline phosphatase (ALP)	4,8, and 12-weeks	Absolute change from baseline to follow-up in alkaline phosphatase (ALP).
Decrease of daily insulin dose	4,8, and 12-weeks	Absolute change from baseline to follow-up of the daily insulin dose.
Change in the prevalence of electrocardiogram events	4,8, and 12-weeks	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.).
Change in high-density lipoprotein cholesterol level	4,8, and 12-weeks	Absolute change from baseline to follow-up in high-density lipoprotein cholesterol level.
Change in gamma-glutamyl transferase (GGT).	4,8, and 12-weeks	Absolute change from baseline to follow-up in gamma-glutamyl transferase (GGT).
Change in glomerular filtration rate	4,8, and 12-weeks	Absolute change from baseline to follow-up in glomerular filtration rate.
Change in thrombocyte aggregation	4,8, and 12-weeks	Absolute change from baseline to follow-up in thrombocyte aggregation.
Lipidom of plasma cells	4,8, and 12-weeks	High sensitivity shotgun mass spectrometry will be used to characterize the lipidome of plasma, and polymorphonuclear blood cells.
Change in fasting insulin	4,8, and 12-weeks	Absolute change from baseline to follow-up in fasting insulin.
Change in heart output	4,8, and 12-weeks	Absolute change from baseline to follow-up in heart output.
Change in the proportion of neuropathy	4,8, and 12-weeks	Absolute change from baseline to follow-up in the proportion of neuropathy
Change in aspartate transaminase (AST)	4,8, and 12-weeks	Absolute change from baseline to follow-up in aspartate transaminase (AST).
Change in alanine transaminase (ALT)	4,8, and 12-weeks	Absolute change from baseline to follow-up in alanine transaminase (ALT).
Lipidom of polymorphonuclear cells	4,8, and 12-weeks	High sensitivity shotgun mass spectrometry will be used to characterize the lipidome of plasma, and polymorphonuclear blood cells.
Change in obstructive sleep apnea proportion	4,8, and 12-weeks	Change in the proportion of obstructive sleep apnea from baseline to follow-up
Change in the proportion of abnormal overnight pulse oximetry	4,8, and 12-weeks	Absolute change from baseline to follow-up in the proportion of abnormal overnight pulse oximetry.
Change in 24-hour blood pressure	4,8, and 12-weeks	Absolute change from baseline to follow-up in 24-hour blood pressure

Trial Locations

Locations (1)

Institute for Translational Medicine, University of Pécs; 🇭🇺 Pécs, Hungary