Diabetes Mellitus, Type 2Sauna-OGTTNCT05610046
The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients
A study testing Infrared sauna heating in people with Diabetes Mellitus, Type 2, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Infrared sauna heating
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Infrared sauna heating, Sham sauna
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared sauna heatingDevice
Participants will sit in an infrared sauna at 60° Celsius (humidity not controlled in an infrared sauna) for a total of 40 minutes.
Sham saunaDevice
Participants will sit in an inactive infrared sauna at room temperature (21° Celsius) for a total of 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Infrared sauna heating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic response (Matsuda index)
OGTT
Measured: 120 minutes
Secondary outcomes (3)
HOMA-IR
fasting glucose and insulin values
Measured: Baseline
Plasma volume/hematocrit
Measured: Throughout test day (3h)
Gutt insulin sensitivity index
from OGTT values
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start26 Jan 2023
- Primary completion14 Apr 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc JC van Loon, Prof. Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610046
- Sponsor's protocol ID
- METC 22-057
- Acronym
- Sauna-OGTT
- Status last verified
- May 2023
- First submitted
- 2 Nov 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients
- ClinicalTrials.gov ID
- NCT05610046
- Acronym / sponsor ID
- Sauna-OGTT / METC 22-057
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Non-heated sauna session | Sham comparator | Device: Sham saunaThe 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. |
| Heated sauna session | Experimental | Device: Infrared sauna heatingThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared sauna heatingParticipants will sit in an infrared sauna at 60° Celsius (humidity not controlled in an infrared sauna) for a total of 40 minutes. | Device | Heated sauna session |
| Sham saunaParticipants will sit in an inactive infrared sauna at room temperature (21° Celsius) for a total of 40 minutes. | Device | Non-heated sauna session |
Primary outcome
Glycaemic response (Matsuda index)
Time frame: 120 minutes
OGTT
3 secondary outcomes
HOMA-IR
Time frame: Baseline
Plasma volume/hematocrit
Time frame: Throughout test day (3h)
Gutt insulin sensitivity index
Time frame: 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc JC van Loon, Prof. Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared sauna heating in people with Diabetes Mellitus, Type 2, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic response (Matsuda index) (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.