Human Neck Brown Adipose Tissue mRNA Profile, a Seasonal... | NCT02486419

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

NCT02486419

Sponsor

Aarhus University Hospital

Status

Completed

Last Update Posted

Aug 3, 2016Estimated

Enrollment

95Actual

Phase

Not provided

Conditions

Nonshivering Thermogenisis

Interventions

Outdoor weather

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jun 22, 2015

First Submission Date that Met QC Criteria

Jun 30, 2015

First Posted Date

Jul 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2016

Last Update Posted Date

Aug 3, 2016Estimated

Name	Class
Novo Nordisk A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Summer			Other: Outdoor weather
Winter			Other: Outdoor weather

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Outdoor weather	Other	Seasonal changes in temperature	Summer Winter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

written concent

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients admitted for neck surgery at Aarhus University Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bjørn Richelsen, MD, PhD	Aarhus University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus	Central Jutland	8000	Denmark