Collection of Human Tissue Samples From the Neck Region for Characterization of Its Molecular and Biochemical Signatures

NCT02274805 | Completed DMC

• 1 other identifier: TRIMD FH 644456
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Brown adipose tissue; Neck surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Day of scheduled surgery

Study Arms (1)

Adults presenting for surgery in the neck area

Procedure: Adults presenting for surgery in the neck area

Interventions

Adults presenting for surgery in the neck area PROCEDURE

Adults presenting for surgery in the neck area

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (9)

• 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.

  PMID: 19357405 BACKGROUND

• 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.

  PMID: 19357406 BACKGROUND

• 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.

  PMID: 18335051 BACKGROUND

• 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.

  PMID: 23747899 BACKGROUND

• 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.

  PMID: 24194874 BACKGROUND

• 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.

  PMID: 23783102 BACKGROUND

• 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.

  PMID: 23867626 BACKGROUND

• 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.

  PMID: 23719558 BACKGROUND

• 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.

  PMID: 23695084 BACKGROUND

Related Links

• Florida Hospital Translational Research Institute for Metabolism and Diabetes

Biospecimen

Retention: SAMPLES WITH DNA

Muscle and adipose tissue from the neck region, and blood samples

MeSH Terms

Conditions

Obesity

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lauren Sparks, PhD

  Translational Research Institute for Metabolism and Diabetes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: October 24, 2014
• Study Start: November 17, 2014
• Primary Completion: April 25, 2019
• Study Completion: December 1, 2020
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)