The Effect of Cold Exposure on Glucose Tolerance

Hyperglycemia Clinical Trial

Official title:

The Effect of Cold Exposure on the Glycaemic and Insulinaemic Responses to an Oral Glucose Load

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700164
• Other study ID #: COGT
• Status: Completed
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: July 2020
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Other:
• Temperature
Water-perfused suit.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose and insulin concentrations in response to an oral glucose load		3 hours post glucose drink, measured 90 minutes after the cold exposure
Secondary	Energy expenditure measured using indirect calorimetry		30 minutes before and during the 1 hour of cold exposure
Secondary	Core temperature measured using a telemetric pill		30 minutes before and during the 1 hour of cold exposure
Secondary	Skin blood flow measured using laser doppler flowmetry		30 minutes before and during the 1 hour of cold exposure
Secondary	Shivering activity assessed using surface electromyography		30 minutes before and during the 1 hour of cold exposure
Secondary	Systolic and diastolic blood pressure measured using an automatic blood pressure device		30 minutes before and during the 1 hour of cold exposure
Secondary	Thermal sensation	How warm or cold the participant perceives the environment. Assessed with a visual analogue scale (scale ranging from cold to hot).	30 minutes before and during the 1 hour of cold exposure
Secondary	Skin temperature measured using iButtons		30 minutes before and during the 1 hour of cold exposure
Secondary	Heart rate measured using chest heart rate monitor sensor		30 minutes before and during the 1 hour of cold exposure
Secondary	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).	30 minutes before and during the 1 hour of cold exposure