Clinical trial NCT02274805: Collection of Human Tissue Samples From the Neck Region for Characterization of Its Molecular and Biochemical Signatures
Official title: Collection of Human Tissue Samples From the Neck Region for Characterization of Its Molecular and Biochemical Signatures
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Keywords: Brown adipose tissue
Neck surgery
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and older presenting for surgery in the neck area
* Able to provide informed consent

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Collection of brown adipose neck tissue
timeFrame: Day of scheduled surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
Study officials:
affiliation: Translational Research Institute for Metabolism and Diabetes
name: Lauren Sparks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cypess 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.
citation: Wijers 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.
citation: Vijgen 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.
citation: Vijgen 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.
citation: Vijgen 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.
citation: van 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.
citation: Vosselman 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.
citation: van 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.