Clinical trial NCT03700164: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: Cold Exposure
Glucose Tolerance
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Glucose and insulin concentrations in response to an oral glucose load
timeFrame: 3 hours post glucose drink, measured 90 minutes after the cold exposure
Secondary outcomes:
measure: Energy expenditure measured using indirect calorimetry
timeFrame: 30 minutes before and during the 1 hour of cold exposure
measure: Core temperature measured using a telemetric pill
timeFrame: 30 minutes before and during the 1 hour of cold exposure
measure: Skin blood flow measured using laser doppler flowmetry
timeFrame: 30 minutes before and during the 1 hour of cold exposure
measure: Shivering activity assessed using surface electromyography
timeFrame: 30 minutes before and during the 1 hour of cold exposure
measure: Systolic and diastolic blood pressure measured using an automatic blood pressure device
timeFrame: 30 minutes before and during the 1 hour of cold exposure
measure: Thermal sensation
timeFrame: 30 minutes before and during the 1 hour of cold exposure
measure: Skin temperature measured using iButtons
timeFrame: 30 minutes before and during the 1 hour of cold exposure
measure: Heart rate measured using chest heart rate monitor sensor
timeFrame: 30 minutes before and during the 1 hour of cold exposure
measure: Comfort
timeFrame: 30 minutes before and during the 1 hour of cold exposure
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Wouter van Marken Lichtenbelt, PhD
role: PRINCIPAL_INVESTIGATOR
References: