The Effect of Cold Exposure on Glucose Tolerance

Sponsor
Maastricht University (Other)
Overall Status
Completed
CT.gov ID
NCT03700164
Collaborator
(none)
16
1
2
9.7
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Temperature
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Cold Exposure on the Glycaemic and Insulinaemic Responses to an Oral Glucose Load
Actual Study Start Date :
Jan 11, 2019
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Energy expenditure measured using indirect calorimetry [30 minutes before and during the 1 hour of cold exposure]

  2. Core temperature measured using a telemetric pill [30 minutes before and during the 1 hour of cold exposure]

  3. Skin blood flow measured using laser doppler flowmetry [30 minutes before and during the 1 hour of cold exposure]

  4. Shivering activity assessed using surface electromyography [30 minutes before and during the 1 hour of cold exposure]

  5. Systolic and diastolic blood pressure measured using an automatic blood pressure device [30 minutes before and during the 1 hour of cold exposure]

  6. Thermal sensation [30 minutes before and during the 1 hour of cold exposure]

    How warm or cold the participant perceives the environment. Assessed with a visual analogue scale (scale ranging from cold to hot).

  7. Skin temperature measured using iButtons [30 minutes before and during the 1 hour of cold exposure]

  8. Heart rate measured using chest heart rate monitor sensor [30 minutes before and during the 1 hour of cold exposure]

  9. Comfort [30 minutes before and during the 1 hour of cold exposure]

    How comfortable or uncomfortable the participant perceives the environment. Comfort assessed with a visual analogue scale (scale ranging from very comfortable to very uncomfortable).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Maastricht Netherlands 6229 ER

Sponsors and Collaborators

  • Maastricht University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maastricht University
ClinicalTrials.gov Identifier:
NCT03700164
Other Study ID Numbers:
  • COGT
First Posted:
Oct 9, 2018
Last Update Posted:
Jul 14, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maastricht University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2020