Human Neck Brown Adipose Tissue mRNA Profile, a Seasonal Variation Study.

Nonshivering Thermogenisis Clinical Trial

Official title:

Human Neck Brown Adipose Tissue mRNA Profile, a Seasonal Variation Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486419
• Other study ID #: 1-10-72-297-14
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: August 2, 2016
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

The primary objective in this study is to examine the seasonal variation in genetic markers in the deep neck adipose tissue in humans.

Human adipose tissue biopsies are taken from patients admitted for elective surgery in the neck. During the surgical procedure a subcutaneous adipose tissue biopsy is taken for reference.

Description:

The knowledge of brown adipose tissue (BAT) is derived mainly from studies in rodents where cold is an important regulator of BAT development and function. Yet, little is known about the regulation of BAT in humans.

With this study the investigators aim to investigate the effects of seasonal changes in outdoor temperature on genetic markers of BAT in human deep neck adipose tissue.

Project participants are patients who are admitted to Aarhus University Hospital for elective neck surgery. Operations are primarily due to suspected malignancy in the thyroid gland or hyperparathyroidism.No additional surgery is necessary to obtain the biopsies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• written concent

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Nonshivering Thermogenisis

Intervention

Other:
• Outdoor weather
Seasonal changes in temperature

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Region Midtjylland

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in gene expression in BAT associated genes (PGC1a, UCP1, CIDEA, PRDM16)	biopsies will be grouped depending on outdoor temperature, differences in subcutaneous- and deep neck values,	1 day (The biopsies will be taken as a "point in time" value. Differences between seasons will be assesed. And so will correlations between genes at one point in time.)	No