The Effect of Cold Exposure on Glucose Tolerance

NCT ID: NCT03700164

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2019-11-01

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.

Conditions

Hyperglycemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cold exposure

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.

Group Type: EXPERIMENTAL

Temperature

Intervention Type: OTHER

Water-perfused suit.

Thermoneutral (Control)

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.

Group Type: OTHER

Temperature

Intervention Type: OTHER

Water-perfused suit.

Interventions

Temperature

Water-perfused suit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wouter van Marken Lichtenbelt, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

COGT

Identifier Type: -

Identifier Source: org_study_id