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Shivering and Glucose Homeostasis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04516018
Enrollment
15
Registered
2020-08-17
Start date
2020-09-01
Completion date
2021-12-13
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Overweight/Obese

Keywords

Type 2 diabetes mellitus, Shivering thermogenesis, skeletal muscle

Brief summary

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

Interventions

OTHERCold exposure

Subjects will be exposed to shivering thermogenesis for at least 1 hour for 10 days

Sponsors

Maastricht University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

a single arm, longitudinal study (10-day intermittent shivering exposure) in a pre-post design

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
area under the curve (AUC) of the glucose tolerance test1 day following cold exposure and following 9 consecutive days of cold exposurearea 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

MeasureTime frameDescription
skeletal muscle GLUT4 translocation1 day following cold exposure and following 9 consecutive days of cold exposureComparison between skeletal muscle GLUT4 translocation, as assessed by wide-field microscopy both before and after cold acclimation

Other

MeasureTime frameDescription
Heart rate1 day following cold exposure and following 9 consecutive days of cold exposureComparison between heart rate during cold exposure both before and after cold acclimation
Blood pressure1 day following cold exposure and following 9 consecutive days of cold exposureComparison between blood pressure during cold exposure both before and after cold acclimation
Energy expenditure1 day following cold exposure and following 9 consecutive days of cold exposureComparison between energy expenditure as assessed by indirect calorimetry both before and after cold acclimation
Substrate oxidation1 day following cold exposure and following 9 consecutive days of cold exposureComparison between substrate oxidation as assessed by indirect calorimetry both before and after cold acclimation
Plasma substrates1 day following cold exposure and following 9 consecutive days of cold exposureComparison between plasma substrates change during cold acclimation (including insulin, FFA, glucose) both before and after cold acclimation
Gene expression in skeletal muscle1 day following cold exposure and following 9 consecutive days of cold exposureComparison between gene expression in skeletal muscle both before and after cold acclimation of specific pathways as determined by RT-qPCR
Skeletal muscle intramyocellular substrate content1 day following cold exposure and following 9 consecutive days of cold exposureComparison between skeletal muscle intramyocellular substrate content both before and after cold acclimation
Protein expression in skeletal muscle1 day following cold exposure and following 9 consecutive days of cold exposureComparison between protein expression in skeletal muscle both before and after cold acclimation of specific pathways as determined by western blot
Body temperatures1 day following cold exposure and following 9 consecutive days of cold exposureChange in both skin and core temperature upon cold acclimation as assessed by means of temperatures sensors and a core temperature pill
Shivering activity1 day following cold exposure and following 9 consecutive days of cold exposureMuscle shivering activity as determined by EMG. Comparison between shivering activity before and after cold acclimation
Plasma hormones1 day following cold exposure and following 9 consecutive days of cold exposureComparison between plasma hormones change during cold acclimation (including insulin, FFA, glucose) both before and after cold acclimation
Insulin sensitivity1 day following cold exposure and following 9 consecutive days of cold exposureComparison between insulin sensitivity as estimated from the insulin and glucose concentrations during the OGTT both before and after cold acclimation.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026