Shivering and Glucose Homeostasis

Sponsor
Maastricht University (Other)
Overall Status
Completed
CT.gov ID
NCT04516018
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Cold exposure
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
a single arm, longitudinal study (10-day intermittent shivering exposure) in a pre-post designa single arm, longitudinal study (10-day intermittent shivering exposure) in a pre-post design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Prolonged Shivering Thermogenesis on Glucose Homeostasis in Overweight/Obese Humans
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Dec 13, 2021
Actual Study Completion Date :
Dec 13, 2021

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. area under the curve (AUC) of the glucose tolerance test [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.

Secondary Outcome Measures

  1. skeletal muscle GLUT4 translocation [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

Other Outcome Measures

  1. Insulin sensitivity [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.

  2. Heart rate [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

  3. Blood pressure [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

  4. Energy expenditure [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

  5. Substrate oxidation [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

  6. Plasma substrates [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

  7. Plasma hormones [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

  8. Skeletal muscle intramyocellular substrate content [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

  9. Protein expression in skeletal muscle [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

  10. Gene expression in skeletal muscle [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

  11. Body temperatures [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

  12. Shivering activity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Maastricht Limburg Netherlands 6229ER

Sponsors and Collaborators

  • Maastricht University

Investigators

  • Principal Investigator: Wouter van Marken Lichtenbelt, Prof., Maastricht University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maastricht University
ClinicalTrials.gov Identifier:
NCT04516018
Other Study ID Numbers:
  • NL73487.068.20
First Posted:
Aug 17, 2020
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maastricht University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022