The Effect of Cold Exposure on Glucose Tolerance

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia
• Intervention / Treatment: Other: Temperature

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 ER
    • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Temperature; Water-perfused suit.
OTHER: 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.	Other: Temperature; Water-perfused suit.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure measured using indirect calorimetry		30 minutes before and during the 1 hour of cold exposure
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
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
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	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

Collaborators and Investigators

• Sponsor: Maastricht University
• Investigators: Principal Investigator: Wouter van Marken Lichtenbelt, PhD, Maastricht University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 11, 2019
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Glucose Tolerance; Cold Exposure
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: COGT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No