Shivering and Glucose Homeostasis

Not Applicable

Completed

• Conditions: Healthy Overweight/Obese
• Interventions: Other: Cold exposure

• Registration Number: NCT04516018
• Lead Sponsor: Maastricht University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-17
• Study Start: 2020-09-01
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cold acclimation arm	Cold exposure	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands