Heat Therapy in Patients With Type 2 Diabetes Mellitus

NCT05237219 | Withdrawn DMC

• 1 other identifier: 818-2/2022/EÜIG
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Keywords

insulin resistance; balneotherapy; additional therapy; alternative therapy; heat shock proteins

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (31)

• Change in hemoglobin A1c level

  4 and 8 weeks

• Change in fasting plasma glucose

  4,8, and 12-weeks

• Change in fasting insulin

  4,8, and 12-weeks

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

  4,8, and 12-weeks

• Decrease of daily insulin dose

  4,8, and 12-weeks

Study Arms (2)

Passive heating

EXPERIMENTAL

Patients will be randomized to receive whole-body passive heating via 38°C natural thermal mineral water baths.

Procedure: Passive heating

Thermoneutral

ACTIVE COMPARATOR

Patients randomized to the comparator group will dip in thermoneutral natural thermal mineral water (30-32°C).

Procedure: Thermoneutral

Interventions

Passive heating PROCEDURE

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.

Passive heating

Thermoneutral PROCEDURE

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.

Thermoneutral

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Institute for Translational Medicine, University of Pécs

Pécs, 7624, Hungary

Location

Related Publications (8)

• 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.

  PMID: 34808071 BACKGROUND

• 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.

  PMID: 22815343 BACKGROUND

• 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.

  PMID: 30389673 BACKGROUND

• 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.

  PMID: 27270841 BACKGROUND

• 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.

  PMID: 30335579 BACKGROUND

• 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.

  PMID: 24523032 BACKGROUND

• 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.

  PMID: 10498473 BACKGROUND

• 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.

  PMID: 35820741 DERIVED

Related Links

• Related info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 14, 2022
• Study Start: May 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)