The Effect of Cold Exposure on Glucose Tolerance

NCT03700164 | Completed

• 1 other identifier: COGT
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Cold Exposure; Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• Glucose and insulin concentrations in response to an oral glucose load

  3 hours post glucose drink, measured 90 minutes after the cold exposure

Secondary Outcomes (9)

• 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

Study Arms (2)

Cold exposure

EXPERIMENTAL

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

Thermoneutral (Control)

OTHER

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

Interventions

Temperature OTHER

Water-perfused suit.

Cold exposure; Thermoneutral (Control)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• White European.
• Male.
• Age 18 - 40 years at the start of the study.
• BMI ≥ 20 and \< 30 kg/m2.

You may not qualify if:

• 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.
• 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.
• Smoking.
• Active diseases (cardiovascular, diabetes mellitus, liver, kidney, cancer or other).

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Temperature

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment, Controlled; Environment and Public Health

Study Officials

• Wouter van Marken Lichtenbelt, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: October 9, 2018
• Study Start: January 11, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

NL (1)