Back to resultsThe Effect of Cold Exposure on Glucose Tolerance
Primary Purpose
Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Temperature
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring Cold Exposure, Glucose Tolerance
Eligibility Criteria
Inclusion Criteria of healthy population:
- Signed informed consent.
- White European.
- Male.
- Age 18 - 40 years at the start of the study.
- BMI ≥ 20 and < 30 kg/m2.
Exclusion Criteria of healthy population:
- 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.
Inclusion Criteria of prediabetes population:
- Signed informed consent.
- 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.
Exclusion Criteria of prediabetes population:
- 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.
Sites / Locations
- Maastricht University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cold exposure
Thermoneutral (Control)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Glucose and insulin concentrations in response to an oral glucose load
Secondary Outcome Measures
Energy expenditure measured using indirect calorimetry
Core temperature measured using a telemetric pill
Skin blood flow measured using laser doppler flowmetry
Shivering activity assessed using surface electromyography
Systolic and diastolic blood pressure measured using an automatic blood pressure device
Thermal sensation
How warm or cold the participant perceives the environment. Assessed with a visual analogue scale (scale ranging from cold to hot).
Skin temperature measured using iButtons
Heart rate measured using chest heart rate monitor sensor
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).
Full Information
NCT ID
NCT03700164
First Posted
September 11, 2018
Last Updated
July 13, 2020
Sponsor
Maastricht University
1. Study Identification
Unique Protocol Identification Number
NCT03700164
Brief Title
The Effect of Cold Exposure on Glucose Tolerance
Official Title
The Effect of Cold Exposure on the Glycaemic and Insulinaemic Responses to an Oral Glucose Load
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Cold Exposure, Glucose Tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold exposure
Arm Type
Experimental
Arm Description
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.
Arm Title
Thermoneutral (Control)
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Temperature
Intervention Description
Water-perfused suit.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Energy expenditure measured using indirect calorimetry
Time Frame
30 minutes before and during the 1 hour of cold exposure
Title
Core temperature measured using a telemetric pill
Time Frame
30 minutes before and during the 1 hour of cold exposure
Title
Skin blood flow measured using laser doppler flowmetry
Time Frame
30 minutes before and during the 1 hour of cold exposure
Title
Shivering activity assessed using surface electromyography
Time Frame
30 minutes before and during the 1 hour of cold exposure
Title
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
Title
Thermal sensation
Description
How warm or cold the participant perceives the environment. Assessed with a visual analogue scale (scale ranging from cold to hot).
Time Frame
30 minutes before and during the 1 hour of cold exposure
Title
Skin temperature measured using iButtons
Time Frame
30 minutes before and during the 1 hour of cold exposure
Title
Heart rate measured using chest heart rate monitor sensor
Time Frame
30 minutes before and during the 1 hour of cold exposure
Title
Comfort
Description
How comfortable or uncomfortable the participant perceives the environment. Comfort assessed with a visual analogue scale (scale ranging from very comfortable to very uncomfortable).
Time Frame
30 minutes before and during the 1 hour of cold exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria of healthy population:
Signed informed consent.
White European.
Male.
Age 18 - 40 years at the start of the study.
BMI ≥ 20 and < 30 kg/m2.
Exclusion Criteria of healthy population:
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.
Inclusion Criteria of prediabetes population:
Signed informed consent.
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.
Exclusion Criteria of prediabetes population:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wouter van Marken Lichtenbelt, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
ZIP/Postal Code
6229 ER
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Effect of Cold Exposure on Glucose Tolerance
We'll reach out to this number within 24 hrs