HyperglycemiaNCT03700164
The Effect of Cold Exposure on Glucose Tolerance
A study testing Temperature in people with Hyperglycemia, run by Maastricht University at 1 site in Netherlands.
Trial summary
The purpose of the study is to evaluate the effect of cold exposure on an individual's glucose tolerance. Previous research has already shown that 10 days acclimation to a mild cold environment (14-15°C) can enhance insulin sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Jan 2019to 1 Nov 2019
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- White European.
- Male.
- Age 18 - 40 years at the start of the study.
- BMI ≥ 20 and < 30 kg/m2.
- Signed informed consent.
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- White European.
- Male or female.
- Women should be postmenopausal or use hormonal contraceptives.
- Age 30 - 75 years at the start of the study.
- BMI ≥ 25 and < 35 kg/m2.
- Generally healthy, no medication use that interferes with metabolism. If volunteers need medication (e.g. statin drugs, NSAIDs), it will be reviewed with the dependent physician on an individual basis.
- Impaired fasting glucose (5.6 mM to 6.9 mM) and/or blood glucose values 7.8-11.0 mM 2h after glucose drink consumption during OGTT in screening.
Who cannot join
- Smoking.
- Active diseases (cardiovascular, diabetes mellitus, liver, kidney, cancer or other).
- Cold-acclimated (takes daily cold baths, works in a refrigerated environment, or regular cold water swimmer).
- Unstable body weight (gain or loss > 5kg in last 3 months).
- Currently undertaking a diet.
- Smoking.
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- Active diseases (cardiovascular, diabetes mellitus, liver, kidney, cancer or other).
- Cold-acclimated (takes daily cold baths, works in a refrigerated environment, or regular cold water swimmer).
- Unstable body weight (gain or loss > 5kg in last 3 months).
- Currently undertaking a diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cold Exposure on the Glycaemic and Insulinaemic Responses to an Oral Glucose Load
The purpose of the study is to evaluate the effect of cold exposure on an individual's glucose tolerance. Previous research has already shown that 10 days acclimation to a mild cold environment (14-15°C) can enhance insulin sensitivity. However, the duration in the cold environment was 6 hours per day which may not be practical for everyone. Therefore, the present study will investigate the effect of a shorter, and more intense cold exposure on an individual's glucose tolerance. It is hypothesised that cold exposure before consuming a glucose drink will enhance glucose clearance.
- Conditions
- Hyperglycemia
- Being tested
- Temperature
- Keywords
- Cold Exposure, Glucose Tolerance
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemperatureOther
Water-perfused suit.
| Study group | Role | What they receive |
|---|---|---|
| Cold exposure | Experimental | Participants will be wrapped in a water-perfused suit. The temperature of the suit will be lowered to 10°C. From the onset of shivering, the participants will remain in the suit for 1 hour. Receives: Other: Temperature |
| Thermoneutral (Control) | Other | Participants will be wrapped in a water-perfused suit. The temperature of the suit will remain at a thermoneutral temperature (32°C) to avoid shivering and excessive sweating.
The duration will be matched to that during the cold exposure. Receives: Other: Temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose and insulin concentrations in response to an oral glucose load
Measured: 3 hours post glucose drink, measured 90 minutes after the cold exposure
Secondary outcomes (9)
Energy expenditure measured using indirect calorimetry
Measured: 30 minutes before and during the 1 hour of cold exposure
Core temperature measured using a telemetric pill
Measured: 30 minutes before and during the 1 hour of cold exposure
Skin blood flow measured using laser doppler flowmetry
Measured: 30 minutes before and during the 1 hour of cold exposure
Shivering activity assessed using surface electromyography
Measured: 30 minutes before and during the 1 hour of cold exposure
Systolic and diastolic blood pressure measured using an automatic blood pressure device
Measured: 30 minutes before and during the 1 hour of cold exposure
Thermal sensation
How warm or cold the participant perceives the environment. Assessed with a visual analogue scale (scale ranging from cold to hot).
Measured: 30 minutes before and during the 1 hour of cold exposure
Skin temperature measured using iButtons
Measured: 30 minutes before and during the 1 hour of cold exposure
Heart rate measured using chest heart rate monitor sensor
Measured: 30 minutes before and during the 1 hour of cold exposure
Comfort
How comfortable or uncomfortable the participant perceives the environment. Comfort assessed with a visual analogue scale (scale ranging from very comfortable to very uncomfortable).
Measured: 30 minutes before and during the 1 hour of cold exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start11 Jan 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- It is anticipated that 32 participants will enrol in the study. Specifically, 16 participants will be healthy individuals and the other 16 will be individuals with impaired fasting glucose (5.6 mM to 6.9 mM) and/or blood glucose values 7.8-11.0 mM 2h after glucose drink consumption during the OGTT in screening. Initially, the study will investigate the effect of the cold exposure on healthy individuals, and then depending on the results in these individuals, the intervention may be tested on participants with impaired glucose metabolism.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wouter van Marken Lichtenbelt, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700164
- Sponsor's protocol ID
- COGT
- Status last verified
- Jul 2020
- First submitted
- 11 Sep 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Exposure on the Glycaemic and Insulinaemic Responses to an Oral Glucose Load
- ClinicalTrials.gov ID
- NCT03700164
- Acronym / sponsor ID
- COGT
- Conditions
- Hyperglycemia
- Keywords
- Cold Exposure, Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 9 Oct 2018 (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.
The purpose of the study is to evaluate the effect of cold exposure on an individual's glucose tolerance. Previous research has already shown that 10 days acclimation to a mild cold environment (14-15°C) can enhance insulin sensitivity. However, the duration in the cold environment was 6 hours per day which may not be practical for everyone. Therefore, the present study will investigate the effect of a shorter, and more intense cold exposure on an individual's glucose tolerance. It is hypothesised that cold exposure before consuming a glucose drink will enhance glucose clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is anticipated that 32 participants will enrol in the study. Specifically, 16 participants will be healthy individuals and the other 16 will be individuals with impaired fasting glucose (5.6 mM to 6.9 mM) and/or blood glucose values 7.8-11.0 mM 2h after glucose drink consumption during the OGTT in screening. Initially, the study will investigate the effect of the cold exposure on healthy individuals, and then depending on the results in these individuals, the intervention may be tested on participants with impaired glucose metabolism.
| Arm | Type | Receives |
|---|---|---|
| Cold exposure | Experimental | Other: TemperatureParticipants will be wrapped in a water-perfused suit. The temperature of the suit will be lowered to 10°C. From the onset of shivering, the participants will remain in the suit for 1 hour. |
| Thermoneutral (Control) | Other | Other: TemperatureParticipants will be wrapped in a water-perfused suit. The temperature of the suit will remain at a thermoneutral temperature (32°C) to avoid shivering and excessive sweating. The duration will be matched to that during the cold exposure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent.
- White European.
- Male.
- Age 18 - 40 years at the start of the study.
- BMI ≥ 20 and < 30 kg/m2.
Key exclusion criteria (10 listed)
- Smoking.
- Active diseases (cardiovascular, diabetes mellitus, liver, kidney, cancer or other).
- Cold-acclimated (takes daily cold baths, works in a refrigerated environment, or regular cold water swimmer).
- Unstable body weight (gain or loss > 5kg in last 3 months).
- Currently undertaking a diet.
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 |
|---|---|---|
| TemperatureWater-perfused suit. | Other | Cold exposure, Thermoneutral (Control) |
Primary outcome
Glucose and insulin concentrations in response to an oral glucose load
Time frame: 3 hours post glucose drink, measured 90 minutes after the cold exposure
9 secondary outcomes
Energy expenditure measured using indirect calorimetry
Time frame: 30 minutes before and during the 1 hour of cold exposure
Core temperature measured using a telemetric pill
Time frame: 30 minutes before and during the 1 hour of cold exposure
Skin blood flow measured using laser doppler flowmetry
Time frame: 30 minutes before and during the 1 hour of cold exposure
Shivering activity assessed using surface electromyography
Time frame: 30 minutes before and during the 1 hour of cold exposure
Systolic and diastolic blood pressure measured using an automatic blood pressure device
Time frame: 30 minutes before and during the 1 hour of cold exposure
Thermal sensation
Time frame: 30 minutes before and during the 1 hour of cold exposure
Skin temperature measured using iButtons
Time frame: 30 minutes before and during the 1 hour of cold exposure
Heart rate measured using chest heart rate monitor sensor
Time frame: 30 minutes before and during the 1 hour of cold exposure
Comfort
Time frame: 30 minutes before and during the 1 hour of cold exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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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.
Wouter van Marken Lichtenbelt, PhD 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 Temperature in people with Hyperglycemia, run by Maastricht University 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 13 inclusion and 10 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: finished, as of the sponsor's last update on 14 Jul 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose and insulin concentrations in response to an oral glucose load (time frame: 3 hours post glucose drink, measured 90 minutes after the cold exposure). 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 14 Jul 2020.