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Clinical Trials/NCT03700164
NCT03700164CompletedNot Applicable

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

Maastricht University2 sites in 1 country16 target enrollmentStarted: January 11, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
2
Primary Endpoint
Glucose and insulin concentrations in response to an oral glucose load

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Glucose and insulin concentrations in response to an oral glucose load

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

Secondary Outcomes

  • Skin temperature measured using iButtons(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(30 minutes before and during the 1 hour of cold exposure)
  • Comfort(30 minutes before and during the 1 hour of cold exposure)
  • 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)
  • Shivering activity assessed using surface electromyography(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)
  • Skin blood flow measured using laser doppler flowmetry(30 minutes before and during the 1 hour of cold exposure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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