NCT04516018

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

July 24, 2020

Last Update Submit

January 13, 2022

Conditions

Healthy Overweight/Obese

Keywords

Type 2 diabetes mellitusShivering thermogenesisskeletal muscle

Outcome Measures

Primary Outcomes (1)

  • area under the curve (AUC) of the glucose tolerance test

    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.

    1 day following cold exposure and following 9 consecutive days of cold exposure

Secondary Outcomes (1)

  • skeletal muscle GLUT4 translocation

    1 day following cold exposure and following 9 consecutive days of cold exposure

Other Outcomes (12)

  • Insulin sensitivity

    1 day following cold exposure and following 9 consecutive days of cold exposure

  • Heart rate

    1 day following cold exposure and following 9 consecutive days of cold exposure

  • Blood pressure

    1 day following cold exposure and following 9 consecutive days of cold exposure

  • +9 more other outcomes

Study Arms (1)

Cold acclimation arm

EXPERIMENTAL

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

Interventions

Cold exposureOTHER

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

Cold acclimation arm

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • Sellers AJ, van Beek SMM, Hashim D, Baak R, Pallubinsky H, Moonen-Kornips E, Schaart G, Gemmink A, Jorgensen JA, van de Weijer T, Kalkhoven E, Hooiveld GJ, Kersten S, Hesselink MKC, Schrauwen P, Hoeks J, van Marken Lichtenbelt WD. Cold acclimation with shivering improves metabolic health in adults with overweight or obesity. Nat Metab. 2024 Dec;6(12):2246-2253. doi: 10.1038/s42255-024-01172-y. Epub 2024 Dec 6.

    PMID: 39643644DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Wouter van Marken Lichtenbelt, Prof.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: a single arm, longitudinal study (10-day intermittent shivering exposure) in a pre-post design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

August 17, 2020

Study Start

September 1, 2020

Primary Completion

December 13, 2021

Study Completion

December 13, 2021

Last Updated

January 14, 2022

Record last verified: 2022-01

Locations

NL(1)