---
title: The Effect of Cold Exposure on Glucose Tolerance
nct_id: NCT03700164
overall_status: COMPLETED
phase: NA
sponsor: Maastricht University
study_type: INTERVENTIONAL
primary_condition: Hyperglycemia
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03700164.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03700164"
ct_last_update_post_date: 2020-07-14
last_seen_at: "2026-05-12T07:23:08.513Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Effect of Cold Exposure on Glucose Tolerance

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

**NCT ID:** [NCT03700164](https://clinicaltrials.gov/study/NCT03700164)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 16
- **Lead Sponsor:** Maastricht University
- **Conditions:** Hyperglycemia
- **Start Date:** 2019-01-11
- **Completion Date:** 2019-11-01
- **CT.gov Last Update:** 2020-07-14

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **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.
```

## Arms

- **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.
- **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.

## Interventions

- **Temperature** (OTHER) — Water-perfused suit.

## 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

- **Energy expenditure measured using indirect calorimetry** _(time frame: 30 minutes before and during the 1 hour of cold exposure)_
- **Core temperature measured using a telemetric pill** _(time frame: 30 minutes before and during the 1 hour of cold exposure)_
- **Skin blood flow measured using laser doppler flowmetry** _(time frame: 30 minutes before and during the 1 hour of cold exposure)_
- **Shivering activity assessed using surface electromyography** _(time frame: 30 minutes before and during the 1 hour of cold exposure)_
- **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)_
- **Thermal sensation** _(time frame: 30 minutes before and during the 1 hour of cold exposure)_
- **Skin temperature measured using iButtons** _(time frame: 30 minutes before and during the 1 hour of cold exposure)_
- **Heart rate measured using chest heart rate monitor sensor** _(time frame: 30 minutes before and during the 1 hour of cold exposure)_
- **Comfort** _(time frame: 30 minutes before and during the 1 hour of cold exposure)_

## Locations (1)

- Maastricht University, Maastricht, Netherlands

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.maastricht university|maastricht||netherlands` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03700164.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03700164*  
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