The Effect of Cold Exposure on Glucose Tolerance

Maastricht University

Status: Completed

Conditions: Hyperglycemia

Treatments: Other: Temperature

Study type: Interventional

Funder types: Other

Identifiers

NCT03700164

COGT

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Cold exposure

Experimental group

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.

Treatment:

Other: Temperature

Thermoneutral (Control)

Other group

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.

Treatment:

Other: Temperature