Clinical trial NCT04516018: Shivering and Glucose Homeostasis
Official title: The Effect of Prolonged Shivering Thermogenesis on Glucose Homeostasis in Overweight/Obese Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Overweight/Obese
Keywords: Type 2 diabetes mellitus
Shivering thermogenesis
skeletal muscle
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a single arm, longitudinal study (10-day intermittent shivering exposure) in a pre-post design
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: area under the curve (AUC) of the glucose tolerance test
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Secondary outcomes:
measure: skeletal muscle GLUT4 translocation
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Other outcomes:
measure: Insulin sensitivity
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Heart rate
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Blood pressure
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Energy expenditure
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Substrate oxidation
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Plasma substrates
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Plasma hormones
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Skeletal muscle intramyocellular substrate content
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Protein expression in skeletal muscle
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Gene expression in skeletal muscle
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Body temperatures
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
measure: Shivering activity
timeFrame: 1 day following cold exposure and following 9 consecutive days of cold exposure
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Wouter van Marken Lichtenbelt, Prof.
role: PRINCIPAL_INVESTIGATOR
References: