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

NCT05610046 | Unknown DMC

• 1 other identifier: METC 22-057
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Glycaemic response (Matsuda index)

  OGTT

  120 minutes

Secondary Outcomes (3)

• HOMA-IR

  Baseline

• Plasma volume/hematocrit

  Throughout test day (3h)

• Gutt insulin sensitivity index

  120 minutes

Study Arms (2)

Non-heated sauna session

SHAM COMPARATOR

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.

Device: Sham sauna

Heated sauna session

EXPERIMENTAL

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.

Device: Infrared sauna heating

Interventions

Infrared sauna heating DEVICE

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

Heated sauna session

Sham sauna DEVICE

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

Non-heated sauna session

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre +

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Luc JC van Loon, Prof. Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this trial, neither the participants, nor the researchers who perform the trial days will be blinded to the intervention allocation. However, the researchers performing the blood analysis are blinded to the treatment allocation and are not involved in the research study during the trial days.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover, randomized, controlled trial

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 8, 2022
• Study Start: January 26, 2023
• Primary Completion: April 14, 2023
• Study Completion: December 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

NL (1)