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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Infrared sauna heating
Sham sauna
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Maastricht University Medical Centre +

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Non-heated sauna session

Heated sauna session

Arm 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.

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.

Outcomes

Primary Outcome Measures

Glycaemic response (Matsuda index)
OGTT

Secondary Outcome Measures

HOMA-IR
fasting glucose and insulin values
Plasma volume/hematocrit
Gutt insulin sensitivity index
from OGTT values

Full Information

First Posted
November 2, 2022
Last Updated
May 3, 2023
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05610046
Brief Title
The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients
Acronym
Sauna-OGTT
Official Title
The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 26, 2023 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover, randomized, controlled trial
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-heated sauna session
Arm Type
Sham Comparator
Arm 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.
Arm Title
Heated sauna session
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Infrared sauna heating
Intervention Description
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
Intervention Name(s)
Sham sauna
Intervention Description
Participants will sit in an inactive infrared sauna at room temperature (21° Celsius) for a total of 40 minutes.
Primary Outcome Measure Information:
Title
Glycaemic response (Matsuda index)
Description
OGTT
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
HOMA-IR
Description
fasting glucose and insulin values
Time Frame
Baseline
Title
Plasma volume/hematocrit
Time Frame
Throughout test day (3h)
Title
Gutt insulin sensitivity index
Description
from OGTT values
Time Frame
120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, Prof. Dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre +
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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