The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients

NCT ID: NCT05610046

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-26
• Study Completion Date: 2023-12-31

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Non-heated sauna session

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.

Group Type: SHAM_COMPARATOR

Sham sauna

Intervention Type: DEVICE

Participants will sit in an inactive infrared sauna at room temperature (21° Celsius) for a total of 40 minutes.

Heated sauna session

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.

Group Type: EXPERIMENTAL

Infrared sauna heating

Intervention Type: DEVICE

Participants will sit in an infrared sauna at 60° Celsius (humidity not controlled in an infrared sauna) for a total of 40 minutes.

Interventions

Infrared sauna heating

Participants will sit in an infrared sauna at 60° Celsius (humidity not controlled in an infrared sauna) for a total of 40 minutes.

Intervention Type: DEVICE

Sham sauna

Participants will sit in an inactive infrared sauna at room temperature (21° Celsius) for a total of 40 minutes.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luc JC van Loon, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University Medical Centre +

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

METC 22-057

Identifier Type: -

Identifier Source: org_study_id