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

August 2, 2016 updated by: Peter Breining, Aarhus University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus, Region Midtjylland, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted for neck surgery at Aarhus University Hospital.

Description

Inclusion Criteria:

  • written concent

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Summer
Other: Outdoor weather
Seasonal changes in temperature
Winter
Other: Outdoor weather
Seasonal changes in temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in gene expression in BAT associated genes (PGC1a, UCP1, CIDEA, PRDM16)
Time Frame: 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.)
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.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Novo Nordisk A/S

Investigators

  • Study Director: Bjørn Richelsen, MD, PhD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (ESTIMATE)

July 1, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1-10-72-297-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Outdoor weather

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe