Hyperglycemia
Conditions
Keywords
Cold Exposure, Glucose Tolerance
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.
Interventions
OTHERTemperature
Water-perfused suit.
Sponsors
Maastricht University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose and insulin concentrations in response to an oral glucose load | 3 hours post glucose drink, measured 90 minutes after the cold exposure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Core temperature measured using a telemetric pill | 30 minutes before and during the 1 hour of cold exposure | — |
| Skin blood flow measured using laser doppler flowmetry | 30 minutes before and during the 1 hour of cold exposure | — |
| Shivering activity assessed using surface electromyography | 30 minutes before and during the 1 hour of cold exposure | — |
| Systolic and diastolic blood pressure measured using an automatic blood pressure device | 30 minutes before and during the 1 hour of cold exposure | — |
| Energy expenditure measured using indirect calorimetry | 30 minutes before and during the 1 hour of cold exposure | — |
| Skin temperature measured using iButtons | 30 minutes before and during the 1 hour of cold exposure | — |
| Heart rate measured using chest heart rate monitor sensor | 30 minutes before and during the 1 hour of cold exposure | — |
| Comfort | 30 minutes before and during the 1 hour of cold exposure | How comfortable or uncomfortable the participant perceives the environment. Comfort assessed with a visual analogue scale (scale ranging from very comfortable to very uncomfortable). |
| Thermal sensation | 30 minutes before and during the 1 hour of cold exposure | How warm or cold the participant perceives the environment. Assessed with a visual analogue scale (scale ranging from cold to hot). |
Countries
Netherlands
Outcome results
None listed