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Completed

NCT Number: NCT03700164

The Effect of Cold Exposure on Glucose Tolerance

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, 6229 ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Temperature

Other

Water-perfused suit.

Primary outcomes

  1. 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

  1. Energy expenditure measured using indirect calorimetry

    Time frame: 30 minutes before and during the 1 hour of cold exposure

  2. Core temperature measured using a telemetric pill

    Time frame: 30 minutes before and during the 1 hour of cold exposure

  3. Skin blood flow measured using laser doppler flowmetry

    Time frame: 30 minutes before and during the 1 hour of cold exposure

  4. Shivering activity assessed using surface electromyography

    Time frame: 30 minutes before and during the 1 hour of cold exposure

  5. Systolic and diastolic blood pressure measured using an automatic blood pressure device

    Time frame: 30 minutes before and during the 1 hour of cold exposure

  6. Thermal sensation

    Time frame: 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

    Time frame: 30 minutes before and during the 1 hour of cold exposure

  8. Heart rate measured using chest heart rate monitor sensor

    Time frame: 30 minutes before and during the 1 hour of cold exposure

  9. Comfort

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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