ObesityHuman BATNCT02274805
Collection of Human Tissue Samples From the Neck Region for Characterization of Its Molecular and Biochemical Signatures
An observational study of Obesity, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to gather tissue (from the neck region), specimens (blood and urine) and medical record data from many patients and store them in one place so that scientists have the information they need to conduct research and learn about new ways to predict, identify and treat illness, specifically… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Adults presenting for surgery in the neck area
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2014to 1 Dec 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a protocol for the collection of muscle and adipose tissues from patients of Dr. Alric Simmonds undergoing surgery in the neck region as part of their clinical care. In addition to the tissues collected at the time of the procedure, these patients will also be asked to provide additional blood samples before their procedure either at their pre-operative visit or on the morning of the surgery.
Who may be able to join
- Adults aged 18 and older presenting for surgery in the neck area
- Able to provide informed consent
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
The purpose of the study is to gather tissue (from the neck region), specimens (blood and urine) and medical record data from many patients and store them in one place so that scientists have the information they need to conduct research and learn about new ways to predict, identify and treat illness, specifically those related to obesity and diabetes.
Read the detailed description
This protocol is designed to actively collect biospecimens (specifically, tissue from the neck region) and clinical data for donation to the TRI-MD, specifically, Dr. Sparks' laboratory. These specimens and data will be available to Dr. Sparks for future research activity in accordance with the Florida Hospital and Translational Research Institute for Metabolism and Diabetes (TRI) policies.
- Conditions
- Obesity
- Being tested
- Adults presenting for surgery in the neck area
- Keywords
- Brown adipose tissue, Neck surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adults presenting for surgery in the neck areaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Adults presenting for surgery in the neck area | Not described Receives: Procedure: Adults presenting for surgery in the neck area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of brown adipose neck tissue
Any tissue deemed suitable by the surgeon and/or the research team during the neck surgery for the study's research objectives will be removed and collected for donation to this protocol. When there is enough tissue available, half will be snap frozen for extraction of DNA, RNA and protein. The other half will be cryopreserved for the future production of viable cells. When there is not enough tissue, the person collecting the samples will determine the processing. For research purposes, we aim to collect up to 500mg of each tissue.
Measured: Day of scheduled surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start17 Nov 2014
- Primary completion25 Apr 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Sparks, PhD, Principal investigator, Translational Research Institute for Metabolism and Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274805
- Sponsor's protocol ID
- TRIMD FH 644456
- Acronym
- Human BAT
- Status last verified
- Apr 2026
- First submitted
- 9 Sep 2014
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718.
PubMed 19357405Cypess AM, Lehman S, Williams G, Tal I, Rodman D, Goldfine AB, Kuo FC, Palmer EL, Tseng YH, Doria A, Kolodny GM, Kahn CR. Identification and importance of brown adipose tissue in adult humans. N Engl J Med. 2009 Apr 9;360(15):1509-17. doi: 10.1056/NEJMoa0810780.
PubMed 19357406Wijers SL, Schrauwen P, Saris WH, van Marken Lichtenbelt WD. Human skeletal muscle mitochondrial uncoupling is associated with cold induced adaptive thermogenesis. PLoS One. 2008 Mar 12;3(3):e1777. doi: 10.1371/journal.pone.0001777.
PubMed 18335051Vijgen G, van Marken Lichtenbelt W. Brown adipose tissue: clinical impact of a re-discovered thermogenic organ. Front Biosci (Elite Ed). 2013 Jun 1;5(3):823-33. doi: 10.2741/e663.
PubMed 23747899Vijgen GH, Bouvy ND, Leenen L, Rijkers K, Cornips E, Majoie M, Brans B, van Marken Lichtenbelt WD. Vagus nerve stimulation increases energy expenditure: relation to brown adipose tissue activity. PLoS One. 2013 Oct 23;8(10):e77221. doi: 10.1371/journal.pone.0077221. eCollection 2013.
PubMed 24194874Vijgen GH, Sparks LM, Bouvy ND, Schaart G, Hoeks J, van Marken Lichtenbelt WD, Schrauwen P. Increased oxygen consumption in human adipose tissue from the "brown adipose tissue" region. J Clin Endocrinol Metab. 2013 Jul;98(7):E1230-4. doi: 10.1210/jc.2013-1348. Epub 2013 Jun 19.
PubMed 23783102van der Lans AA, Hoeks J, Brans B, Vijgen GH, Visser MG, Vosselman MJ, Hansen J, Jorgensen JA, Wu J, Mottaghy FM, Schrauwen P, van Marken Lichtenbelt WD. Cold acclimation recruits human brown fat and increases nonshivering thermogenesis. J Clin Invest. 2013 Aug;123(8):3395-403. doi: 10.1172/JCI68993. Epub 2013 Jul 15.
PubMed 23867626Vosselman MJ, Brans B, van der Lans AA, Wierts R, van Baak MA, Mottaghy FM, Schrauwen P, van Marken Lichtenbelt WD. Brown adipose tissue activity after a high-calorie meal in humans. Am J Clin Nutr. 2013 Jul;98(1):57-64. doi: 10.3945/ajcn.113.059022. Epub 2013 May 29.
PubMed 23719558van Rooijen BD, van der Lans AA, Brans B, Wildberger JE, Mottaghy FM, Schrauwen P, Backes WH, van Marken Lichtenbelt WD. Imaging cold-activated brown adipose tissue using dynamic T2*-weighted magnetic resonance imaging and 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography. Invest Radiol. 2013 Oct;48(10):708-14. doi: 10.1097/RLI.0b013e31829363b8.
PubMed 23695084
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Human Tissue Samples From the Neck Region for Characterization of Its Molecular and Biochemical Signatures
- ClinicalTrials.gov ID
- NCT02274805
- Acronym / sponsor ID
- Human BAT / TRIMD FH 644456
- Conditions
- Obesity
- Keywords
- Brown adipose tissue, Neck surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Oct 2014 (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 purpose of the study is to gather tissue (from the neck region), specimens (blood and urine) and medical record data from many patients and store them in one place so that scientists have the information they need to conduct research and learn about new ways to predict, identify and treat illness, specifically those related to obesity and diabetes.
Detailed description
This protocol is designed to actively collect biospecimens (specifically, tissue from the neck region) and clinical data for donation to the TRI-MD, specifically, Dr. Sparks' laboratory. These specimens and data will be available to Dr. Sparks for future research activity in accordance with the Florida Hospital and Translational Research Institute for Metabolism and Diabetes (TRI) policies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults presenting for surgery in the neck area | – | Procedure: Adults presenting for surgery in the neck area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a protocol for the collection of muscle and adipose tissues from patients of Dr. Alric Simmonds undergoing surgery in the neck region as part of their clinical care. In addition to the tissues collected at the time of the procedure, these patients will also be asked to provide additional blood samples before their procedure either at their pre-operative visit or on the morning of the surgery.
Key inclusion criteria (2 listed)
- Adults aged 18 and older presenting for surgery in the neck area
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Unable to provide informed consent
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 |
|---|---|---|
| Adults presenting for surgery in the neck area | Procedure or surgery | Adults presenting for surgery in the neck area |
Primary outcome
Collection of brown adipose neck tissue
Time frame: Day of scheduled surgery
Any tissue deemed suitable by the surgeon and/or the research team during the neck surgery for the study's research objectives will be removed and collected for donation to this protocol. When there is enough tissue available, half will be snap frozen for extraction of DNA, RNA and protein. The other half will be cryopreserved for the future production of viable cells. When there is not enough tissue, the person collecting the samples will determine the processing. For research purposes, we aim to collect up to 500mg of each tissue.
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 17 Apr 2026.
- Background: PubMed 19357405van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718.
- Background: PubMed 19357406Cypess AM, Lehman S, Williams G, Tal I, Rodman D, Goldfine AB, Kuo FC, Palmer EL, Tseng YH, Doria A, Kolodny GM, Kahn CR. Identification and importance of brown adipose tissue in adult humans. N Engl J Med. 2009 Apr 9;360(15):1509-17. doi: 10.1056/NEJMoa0810780.
- Background: PubMed 18335051Wijers SL, Schrauwen P, Saris WH, van Marken Lichtenbelt WD. Human skeletal muscle mitochondrial uncoupling is associated with cold induced adaptive thermogenesis. PLoS One. 2008 Mar 12;3(3):e1777. doi: 10.1371/journal.pone.0001777.
- Background: PubMed 23747899Vijgen G, van Marken Lichtenbelt W. Brown adipose tissue: clinical impact of a re-discovered thermogenic organ. Front Biosci (Elite Ed). 2013 Jun 1;5(3):823-33. doi: 10.2741/e663.
- Background: PubMed 24194874Vijgen GH, Bouvy ND, Leenen L, Rijkers K, Cornips E, Majoie M, Brans B, van Marken Lichtenbelt WD. Vagus nerve stimulation increases energy expenditure: relation to brown adipose tissue activity. PLoS One. 2013 Oct 23;8(10):e77221. doi: 10.1371/journal.pone.0077221. eCollection 2013.
- Background: PubMed 23783102Vijgen GH, Sparks LM, Bouvy ND, Schaart G, Hoeks J, van Marken Lichtenbelt WD, Schrauwen P. Increased oxygen consumption in human adipose tissue from the "brown adipose tissue" region. J Clin Endocrinol Metab. 2013 Jul;98(7):E1230-4. doi: 10.1210/jc.2013-1348. Epub 2013 Jun 19.
- Background: PubMed 23867626van der Lans AA, Hoeks J, Brans B, Vijgen GH, Visser MG, Vosselman MJ, Hansen J, Jorgensen JA, Wu J, Mottaghy FM, Schrauwen P, van Marken Lichtenbelt WD. Cold acclimation recruits human brown fat and increases nonshivering thermogenesis. J Clin Invest. 2013 Aug;123(8):3395-403. doi: 10.1172/JCI68993. Epub 2013 Jul 15.
- Background: PubMed 23719558Vosselman MJ, Brans B, van der Lans AA, Wierts R, van Baak MA, Mottaghy FM, Schrauwen P, van Marken Lichtenbelt WD. Brown adipose tissue activity after a high-calorie meal in humans. Am J Clin Nutr. 2013 Jul;98(1):57-64. doi: 10.3945/ajcn.113.059022. Epub 2013 May 29.
- Background: PubMed 23695084van Rooijen BD, van der Lans AA, Brans B, Wildberger JE, Mottaghy FM, Schrauwen P, Backes WH, van Marken Lichtenbelt WD. Imaging cold-activated brown adipose tissue using dynamic T2*-weighted magnetic resonance imaging and 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography. Invest Radiol. 2013 Oct;48(10):708-14. doi: 10.1097/RLI.0b013e31829363b8.
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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.
Lauren Sparks, PhD principal investigator
Translational Research Institute for Metabolism and Diabetes
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 Obesity, run by AdventHealth Translational Research Institute at 1 site in United States.
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 2 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 17 Apr 2026. 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 United States. 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?
Collection of brown adipose neck tissue (time frame: Day of scheduled surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02274805, which also lists 9 linked publications.
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 17 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.