Shivering and Glucose Homeostasis

January 13, 2022 updated by: Maastricht University

The Effect of Prolonged Shivering Thermogenesis on Glucose Homeostasis in Overweight/Obese Humans

The purpose of this study is to investigate the effect of prolonged shivering thermogenesis on glucose homeostasis in overweight/obese humans.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Caucasian
  • Healthy (as determined by dependent physician based on medical questionnaire)
  • Man, or postmenopausal (defined as at least 1year post cessation of menses) woman
  • Aged 40 - 75 years at the start of the study
  • BMI 27 and 35 kg/m2
  • Stable dietary habits (no weight loss or gain >3kg in the past 3 months)

Exclusion Criteria:

  • - Not meeting all inclusion criteria
  • Medication use known to hamper subject's safety during study procedures
  • Co-morbidities to which the intervention or program that may pose as a complicating factor
  • Subjects diagnosed with cardiovascular diseases or cancer
  • Fasting plasma glucose ≥ 7.0 mmol/l
  • Haemoglobin < 7.8 mmol/l for women, or < 8.4 mmol/l for men
  • Previously diagnosed with type 2 diabetes
  • Abuse alcohol/drug abuse
  • Subjects who do not want to be informed about unexpected medical findings during the screening/study or do not wish that their physician is informed.
  • Engagement in structured exercise > 2h per week
  • Participation in another biomedical study within 1 month before the first study
  • Smoking
  • Cold-acclimated, such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cold acclimation arm
An oral glucose tolerance test will be performed on day 1 of the study. The next day (day 2), subjects will be exposed to shivering thermogenesis for at least 1 hour. The day after, an oral glucose tolerance test will be performed (day 3). The following 9 days, subjects will be exposed daily to shivering thermogenesis for at least 1 hour (day 4-12). On the last day (day 13), an oral glucose tolerance test will be performed.
Other: Cold exposure
Subjects will be exposed to shivering thermogenesis for at least 1 hour for 10 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
area under the curve (AUC) of the glucose tolerance test
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
area under the curve (AUC) of the glucose tolerance test before cold exposure, 1 day after cold exposure and after 9 consecutive days of cold exposure.
1 day following cold exposure and following 9 consecutive days of cold exposure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
skeletal muscle GLUT4 translocation
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between skeletal muscle GLUT4 translocation, as assessed by wide-field microscopy both before and after cold acclimation
1 day following cold exposure and following 9 consecutive days of cold exposure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between insulin sensitivity as estimated from the insulin and glucose concentrations during the OGTT both before and after cold acclimation.
1 day following cold exposure and following 9 consecutive days of cold exposure
Heart rate
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between heart rate during cold exposure both before and after cold acclimation
1 day following cold exposure and following 9 consecutive days of cold exposure
Blood pressure
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between blood pressure during cold exposure both before and after cold acclimation
1 day following cold exposure and following 9 consecutive days of cold exposure
Energy expenditure
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between energy expenditure as assessed by indirect calorimetry both before and after cold acclimation
1 day following cold exposure and following 9 consecutive days of cold exposure
Substrate oxidation
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between substrate oxidation as assessed by indirect calorimetry both before and after cold acclimation
1 day following cold exposure and following 9 consecutive days of cold exposure
Plasma substrates
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between plasma substrates change during cold acclimation (including insulin, FFA, glucose) both before and after cold acclimation
1 day following cold exposure and following 9 consecutive days of cold exposure
Plasma hormones
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between plasma hormones change during cold acclimation (including insulin, FFA, glucose) both before and after cold acclimation
1 day following cold exposure and following 9 consecutive days of cold exposure
Skeletal muscle intramyocellular substrate content
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between skeletal muscle intramyocellular substrate content both before and after cold acclimation
1 day following cold exposure and following 9 consecutive days of cold exposure
Protein expression in skeletal muscle
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between protein expression in skeletal muscle both before and after cold acclimation of specific pathways as determined by western blot
1 day following cold exposure and following 9 consecutive days of cold exposure
Gene expression in skeletal muscle
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Comparison between gene expression in skeletal muscle both before and after cold acclimation of specific pathways as determined by RT-qPCR
1 day following cold exposure and following 9 consecutive days of cold exposure
Body temperatures
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Change in both skin and core temperature upon cold acclimation as assessed by means of temperatures sensors and a core temperature pill
1 day following cold exposure and following 9 consecutive days of cold exposure
Shivering activity
Time Frame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Muscle shivering activity as determined by EMG. Comparison between shivering activity before and after cold acclimation
1 day following cold exposure and following 9 consecutive days of cold exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wouter van Marken Lichtenbelt, Prof., Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL73487.068.20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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