Nonshivering ThermogenisisNCT02486419
Human Neck Brown Adipose Tissue mRNA Profile, a Seasonal Variation Study.
An observational study of Nonshivering Thermogenisis, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nonshivering Thermogenisis
- What is being tested?
- Outdoor weather
- How many people
- 95 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients admitted for neck surgery at Aarhus University Hospital.
Who may be able to join
- written concent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Nonshivering Thermogenisis
- Being tested
- Outdoor weather
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor weatherOther
Seasonal changes in temperature
| Study group | Role | What they receive |
|---|---|---|
| Summer | Not described Receives: Other: Outdoor weather | |
| Winter | Not described Receives: Other: Outdoor weather |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonshivering ThermogenisisStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Peter Breining, Aarhus University Hospital
- Investigators
- Bjørn Richelsen, MD, PhD, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486419
- Sponsor's protocol ID
- 1-10-72-297-14
- Status last verified
- Aug 2016
- First submitted
- 22 Jun 2015
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Neck Brown Adipose Tissue mRNA Profile, a Seasonal Variation Study.
- ClinicalTrials.gov ID
- NCT02486419
- Acronym / sponsor ID
- 1-10-72-297-14
- Conditions
- Nonshivering Thermogenisis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Feb 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Summer | – | Other: Outdoor weather |
| Winter | – | Other: Outdoor weather |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted for neck surgery at Aarhus University Hospital.
Key inclusion criteria (1 listed)
- written concent
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outdoor weatherSeasonal changes in temperature | Other | Summer, Winter |
Primary outcome
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,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjørn Richelsen, MD, PhD study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonshivering Thermogenisis, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.