NCT05884177

Brief Summary

Brown adipose tissue (BAT) produces heat through non-shivering thermogenesis. It is activated by cold exposure, and when activated it utilizes fatty acids and glucose in order to produce heat. The tissue is especially present in newborns, who not yet have gained a layer of insulating fat to protect from heat loss, and not yet have gained much muscle to produce heat through shivering thermogenesis. It was long thought that BAT mass hereafter would retract. Modern imaging tools have proved that BAT is persistent and active in some adults. The presence and activity of BAT is negatively correlated with obesity and obesity-related metabolic disorders. The tissue retracts with advancing age and increasing BMI, and it is sensitive to environmental factors, such as diet, weather and climate. The key to activating BAT in subjects that have lost it remains elusive. BAT is activated to produce heat when exposed to cold. Populations that are most cold exposed include people living in the Arctic. It is known that people of Arctic origin such as indigenous Inuit and indigenous Siberians have genetically adapted to and are acclimatized to the cold through several genetic changes, and possibly by upregulating BAT depots and activity. The investigators aim to dig deeper into the activation mechanisms in BAT, by investigating BAT mass and activity in Greenlanders and non-Greenlanders by use of stage-of-the-art modern techniques.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 4, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

May 4, 2023

Last Update Submit

August 21, 2023

Conditions

Keywords

Brown Adipose Tissue

Outcome Measures

Primary Outcomes (1)

  • BAT detection

    BAT mass in the cervical-upper thoracic, abdominal, and paravertebral regions at room temperature and following short-term cold exposure. BAT mass on PET/CT scans will be quantified by the degree of glucose uptake: Maximum standard unit value (SUVmax)

    Through study completion, analysis for an average of 1 year

Secondary Outcomes (5)

  • Temperature of the core and at the skin on multiple sites

    Through study completion, analysis for an average of 1 year

  • Changes in thyroid function

    Through study completion, analysis for an average of 1 year

  • Changes in metabolites

    Through study completion, analysis for an average of 1 year

  • Insulin sensitivity

    Through study completion, analysis for an average of 1 year

  • Adipose tissue composition

    Through study completion, analysis for an average of 1 year

Study Arms (2)

Greenlanders

Subjects born in Greenland with parents born in Greenland

Other: Short-term cold exposure

non-Greenlanders

Subjects not born in Greenland with parents not born in Greenland

Other: Short-term cold exposure

Interventions

Short-term cold exposure

Greenlandersnon-Greenlanders

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy, lean, young Greenlanders and non-Greenlanders living in Denmark

You may qualify if:

  • Ability to give informed consent
  • Ability to follow written and verbal instructions

You may not qualify if:

  • Pregnancy and breastfeeding
  • Alpha- or beta-adrenergic affecting medication.
  • Thyroid dysfunction
  • Liver or kidney disease
  • Treatment for diabetes
  • MODY and TBC1D4
  • Treatment of obesity
  • Cardiovascular disease
  • Cancer within 3 years
  • Mb Renaud
  • Hospitalisation for psychiatric disease
  • Antipsychotic medication
  • Drug abuse within 1-year
  • Alcohol abuse
  • Plasma glucose \> 11 mM
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Related Publications (1)

  • Motzfeldt Jensen M, Almasi CE, Kjaergaard B, Rasmussen BS, Andersen MK, Schubert M, Hansen T, Ellervik C, Scheele C, Jorgensen ME, Andersen S. Brown Adipose Tissue and Metabolic Markers Differ Between Greenlanders and Danes with Cold-Activation. J Clin Endocrinol Metab. 2025 Nov 17:dgaf615. doi: 10.1210/clinem/dgaf615. Online ahead of print.

Central Study Contacts

Mette MM Jensen, MD

CONTACT

Stig Andersen, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department Head

Study Record Dates

First Submitted

May 4, 2023

First Posted

June 1, 2023

Study Start

September 18, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Restrictions apply due to limited number of participants

Locations