The Effect of Cold Exposure on Glucose Tolerance | NCT03700164

Studies
The Effect of Cold Exposure on Glucose Tolerance

NCT03700164

Sponsor

Maastricht University

Status

Completed

Last Update Posted

Jul 14, 2020Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Hyperglycemia

Interventions

Temperature

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2019Actual

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Nov 1, 2019Actual

First Submitted Date

Sep 11, 2018

First Submission Date that Met QC Criteria

Oct 8, 2018

First Posted Date

Oct 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2020

Last Update Posted Date

Jul 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Temperature	Other	Water-perfused suit.	Cold exposure Thermoneutral (Control)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Wouter van Marken Lichtenbelt, PhD	Maastricht University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		Maastricht		6229 ER	Netherlands

ID	Term
D006943	Hyperglycemia

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D013696	Temperature

ID	Term
D013816	Thermodynamics
D055585	Physical Phenomena
D014887	Weather
D001272	Atmosphere

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.