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Diabetes Mellitus, Type 2HEATEDNCT05237219

Heat Therapy in Patients With Type 2 Diabetes Mellitus

A study testing Passive heating and Thermoneutral in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Pecs at 1 site in Hungary.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2, Insulin Resistance
What is being tested?
Passive heating and Thermoneutral
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteHungary
Study dates
1 May 2022to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Institute for Translational Medicine, University of Pécs

    Pécs, 7624

Other trials in Hungary

About this study

Official title: The Effect of HEAT Therapy on patiEnts With Type 2 Diabetes Mellitus (HEATED): Protocol of a Randomized, Two-arm Controlled Trial

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.

Read the 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.

Being tested
Passive heating, Thermoneutral
Keywords
insulin resistance, balneotherapy, additional therapy, alternative therapy, heat shock proteins
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Passive heatingProcedure or surgery

    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 or surgery

    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.

Study groups in NCT05237219
Study groupRoleWhat they receive
Passive heatingExperimentalPatients will be randomized to receive whole-body passive heating via 38°C natural thermal mineral water baths.
Receives: Procedure: Passive heating
ThermoneutralActive comparatorPatients randomized to the comparator group will dip in thermoneutral natural thermal mineral water (30-32°C).
Receives: Procedure: Thermoneutral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in hemoglobin A1c level

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

    Measured: 12 weeks

Secondary outcomes (31)

  1. Change in hemoglobin A1c level

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

    Measured: 4 and 8 weeks

  2. Change in fasting plasma glucose

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

    Measured: 4,8, and 12-weeks

  3. Change in fasting insulin

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

    Measured: 4,8, and 12-weeks

  4. 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).

    Measured: 4,8, and 12-weeks

  5. Decrease of daily insulin dose

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

    Measured: 4,8, and 12-weeks

  6. 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.

    Measured: 4,8, and 12-weeks

  7. Change in mean blood pressure

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

    Measured: 4,8, and 12-weeks

  8. Change in heart output

    Absolute change from baseline to follow-up in heart output.

    Measured: 4,8, and 12-weeks

  9. 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.).

    Measured: 4,8, and 12-weeks

  10. Change in the proportion of hypertension

    Absolute change from baseline to follow-up in the proportion of hypertension

    Measured: 4,8, and 12-weeks

  11. Change in the proportion of retinopathy

    Absolute change from baseline to follow-up in the proportion of retinopathy

    Measured: 4,8, and 12-weeks

  12. Change in the proportion of nephropathy

    Absolute change from baseline to follow-up in the proportion of nephropathy

    Measured: 4,8, and 12-weeks

  13. Change in the proportion of neuropathy

    Absolute change from baseline to follow-up in the proportion of neuropathy

    Measured: 4,8, and 12-weeks

  14. Change in total cholesterol level

    Absolute change from baseline to follow-up in total cholesterol level.

    Measured: 4,8, and 12-weeks

  15. Change in low-density lipoprotein cholesterol level

    Absolute change from baseline to follow-up in low-density lipoprotein cholesterol level.

    Measured: 4,8, and 12-weeks

  16. Change in high-density lipoprotein cholesterol level

    Absolute change from baseline to follow-up in high-density lipoprotein cholesterol level.

    Measured: 4,8, and 12-weeks

  17. Change in triglyceride level

    Absolute change from baseline to follow-up in triglyceride level.

    Measured: 4,8, and 12-weeks

  18. Change in alkaline phosphatase (ALP)

    Absolute change from baseline to follow-up in alkaline phosphatase (ALP).

    Measured: 4,8, and 12-weeks

  19. Change in alanine transaminase (ALT)

    Absolute change from baseline to follow-up in alanine transaminase (ALT).

    Measured: 4,8, and 12-weeks

  20. Change in aspartate transaminase (AST)

    Absolute change from baseline to follow-up in aspartate transaminase (AST).

    Measured: 4,8, and 12-weeks

  21. Change in gamma-glutamyl transferase (GGT).

    Absolute change from baseline to follow-up in gamma-glutamyl transferase (GGT).

    Measured: 4,8, and 12-weeks

  22. Change in glomerular filtration rate

    Absolute change from baseline to follow-up in glomerular filtration rate.

    Measured: 4,8, and 12-weeks

  23. Change in creatinine level

    Absolute change from baseline to follow-up in creatinine.

    Measured: 4,8, and 12-weeks

  24. Change in thrombocyte aggregation

    Absolute change from baseline to follow-up in thrombocyte aggregation.

    Measured: 4,8, and 12-weeks

  25. Heat Shock Protein expression

    Difference between the two groups in the level of protein expression using flow cytometry.

    Measured: 4,8, and 12-weeks

  26. Insulin signaling in polymorphonuclear cells

    Difference between the two groups in the level of protein expression using flow cytometry.

    Measured: 4,8, and 12-weeks

  27. Lipidom of polymorphonuclear cells

    High sensitivity shotgun mass spectrometry will be used to characterize the lipidome of plasma, and polymorphonuclear blood cells.

    Measured: 4,8, and 12-weeks

  28. Lipidom of plasma cells

    High sensitivity shotgun mass spectrometry will be used to characterize the lipidome of plasma, and polymorphonuclear blood cells.

    Measured: 4,8, and 12-weeks

  29. Change in obstructive sleep apnea proportion

    Change in the proportion of obstructive sleep apnea from baseline to follow-up

    Measured: 4,8, and 12-weeks

  30. Change in the proportion of abnormal overnight pulse oximetry

    Absolute change from baseline to follow-up in the proportion of abnormal overnight pulse oximetry.

    Measured: 4,8, and 12-weeks

  31. Change in 24-hour blood pressure

    Absolute change from baseline to follow-up in 24-hour blood pressure

    Measured: 4,8, and 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start1 May 2022 (estimated)
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Why it stopped: The human resources required to start enrollment were not available anymore.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05237219
Sponsor's protocol ID
818-2/2022/EÜIG
Acronym
HEATED
Status last verified
Apr 2023
First submitted
5 Jan 2022
Last updated
20 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sebok J, Edel Z, Vancsa S, Farkas N, Kiss S, Eross B, Torok Z, Balogh G, Balogi Z, Nagy R, Hooper PL, Geiger PC, Wittmann I, Vigh L, Dembrovszky F, Hegyi P. Heat therapy shows benefit in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. Int J Hyperthermia. 2021;38(1):1650-1659. doi: 10.1080/02656736.2021.2003445.

    PubMed 34808071

  • Romeo GR, Lee J, Shoelson SE. Metabolic syndrome, insulin resistance, and roles of inflammation--mechanisms and therapeutic targets. Arterioscler Thromb Vasc Biol. 2012 Aug;32(8):1771-6. doi: 10.1161/ATVBAHA.111.241869.

    PubMed 22815343

  • Salas-Salvado J, Diaz-Lopez A, Ruiz-Canela M, Basora J, Fito M, Corella D, Serra-Majem L, Warnberg J, Romaguera D, Estruch R, Vidal J, Martinez JA, Aros F, Vazquez C, Ros E, Vioque J, Lopez-Miranda J, Bueno-Cavanillas A, Tur JA, Tinahones FJ, Martin V, Lapetra J, Pinto X, Daimiel L, Delgado-Rodriguez M, Matia P, Gomez-Gracia E, Diez-Espino J, Babio N, Castaner O, Sorli JV, Fiol M, Zulet MA, Bullo M, Goday A, Martinez-Gonzalez MA; PREDIMED-Plus investigators. Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial. Diabetes Care. 2019 May;42(5):777-788. doi: 10.2337/dc18-0836. Epub 2018 Nov 2.

    PubMed 30389673

  • Brunt VE, Howard MJ, Francisco MA, Ely BR, Minson CT. Passive heat therapy improves endothelial function, arterial stiffness and blood pressure in sedentary humans. J Physiol. 2016 Sep 15;594(18):5329-42. doi: 10.1113/JP272453. Epub 2016 Jun 30.

    PubMed 27270841

  • Hoekstra SP, Bishop NC, Faulkner SH, Bailey SJ, Leicht CA. Acute and chronic effects of hot water immersion on inflammation and metabolism in sedentary, overweight adults. J Appl Physiol (1985). 2018 Dec 1;125(6):2008-2018. doi: 10.1152/japplphysiol.00407.2018. Epub 2018 Oct 18.

    PubMed 30335579

  • Hooper PL, Balogh G, Rivas E, Kavanagh K, Vigh L. The importance of the cellular stress response in the pathogenesis and treatment of type 2 diabetes. Cell Stress Chaperones. 2014 Jul;19(4):447-64. doi: 10.1007/s12192-014-0493-8. Epub 2014 Feb 13.

    PubMed 24523032

  • Hooper PL. Hot-tub therapy for type 2 diabetes mellitus. N Engl J Med. 1999 Sep 16;341(12):924-5. doi: 10.1056/NEJM199909163411216. No abstract available.

    PubMed 10498473

  • Sebok J, Edel Z, Dembrovszky F, Farkas N, Torok Z, Balogh G, Peter M, Papp I, Balogi Z, Nusser N, Peter I, Hooper P, Geiger P, Eross B, Wittmann I, Vancsa S, Vigh L, Hegyi P. Effect of HEAT therapy in patiEnts with type 2 Diabetes mellitus (HEATED): protocol for a randomised controlled trial. BMJ Open. 2022 Jul 12;12(7):e062122. doi: 10.1136/bmjopen-2022-062122.

    PubMed 35820741

Questions about this trial

What is this clinical trial studying?

A study testing Passive heating and Thermoneutral in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Pecs at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hemoglobin A1c level (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05237219, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.

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