Clinical trial NCT05610046: The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients
Official title: The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover, randomized, controlled trial
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Glycaemic response (Matsuda index)
timeFrame: 120 minutes
Secondary outcomes:
measure: HOMA-IR
timeFrame: Baseline
measure: Plasma volume/hematocrit
timeFrame: Throughout test day (3h)
measure: Gutt insulin sensitivity index
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre +
Study officials:
affiliation: Maastricht University
name: Luc JC van Loon, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: