The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients (Sauna-OGTT)

Maastricht University Medical Centre (MUMC)

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Infrared sauna heating; Device: Sham sauna

Study type: Interventional

Funder types: Other

Identifiers

NCT05610046

METC 22-057

Details and patient eligibility

About

Type 2 diabetes mellitus (T2DM) is a metabolic disease with a rapidly increasing incidence world-wide. The disease is characterizedby a decreased glucose tolerance as a result of insulin resistance, resulting in poor blood glycaemic control. Blood glucose loweringmedications are widely available, but their effect stagnates as T2DM progresses. New treatment regimens are required to combatthe disease. Although therapies such as physical exercise have been shown to induce beneficial effects on glycaemic control inT2DM patients, not all patients are able to perform exercise. Passive heating treatment (PHT) might be an alternative strategy toreduce insulin resistance, as it has been postulated to have comparable effects on the cardiovascular system as exercise. PHT hasbeen linked to numerous health benefits, including improved cardiovascular- and pulmonary function, pain alleviation and metabolichealth. In addition, long term use of PHT shows promising effects on glycaemic control in T2DM patients. However, the acute effectsof PHT on glucoregulation are yet to be determined. Therefore, in this study we will assess the acute impact of passive heat treatment on the post-prandial glycaemic response during an OGTT in T2DM patients

Enrollment: 12 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥50 years old
• Body mass index 18.5 - 35 kg/m2
• DM type 2
• Using oral blood glucose lowering medication
• Able to give informed consent

Exclusion criteria

• Insulin dependence
• Changes in diabetes medication in the past 3 months
• Allergy for one of the food items used
• >5% weight change in the previous 6 months
• Participating in a structured (progressive) exercise program, or in the past 3 months.
• Frequent (once per week or more) user of infrared (or traditional) sauna in the past 3 months
• Inability to tolerate sauna/high temperatures
• Smoking
• Diagnosed with cardiovascular disease (e.g. unstable angina pectoris or recent myocardial infarction), kidney failure (eGFR < 60 ml/min/1.73m2), rheumatoid arthritis
• Diagnosed musculoskeletal, GI tract, metabolic (except diabetes) or pulmonary (e.g. COPD) disorders that are expected to influence study outcomes
• Having a pacemaker, defibrillator, or any other type of metal implant

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Non-heated sauna session

Sham Comparator group

Description:

The test days will consist of sitting in an infrared sauna cabin (HM-LSE-3 Professional edition, Health Mate, Belgium). Participants will sit in an infrared sauna at 21° Celsius for a total of 40 minutes.

Treatment:

Device: Sham sauna

Heated sauna session

Experimental group

Description:

The test days will consist of sitting in an infrared sauna cabin (HM-LSE-3 Professional edition, Health Mate, Belgium). Participants will sit in an infrared sauna at 60° Celsius (humidity not controlled in an infrared sauna) for a total of 40 minutes.

Treatment:

Device: Infrared sauna heating