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Completed

NCT Number: NCT04516018

Shivering and Glucose Homeostasis

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

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Key information

Conditions

Healthy Overweight/Obese Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold exposure

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2020
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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