Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism

NCT02692885 | Recruiting

• 2 other identifiers: 16006816-DK-0068
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The body uses energy from calories for basic functions like breathing and digesting food. Over time, when a person eats more calories than they burn, they may become overweight or obese. Obesity is a major health concern. Researchers want to look at fat and muscle tissue to learn more about metabolism. That is how the body uses food and other nutrients for normal function and energy. This research may help to develop new treatments for obesity and related diseases. Objective: To learn more about the role of fat and muscle in metabolism, particularly how fat and muscle store and use energy. Eligibility: Adults 18 years and older who have a planned surgery at NIH in which tissue can be collected by the surgeon. Design: Participants will be screened by their regular NIH doctor. Then researchers will contact them about this study. Participants will not have to make extra visits to NIH for this study. Researchers will collect samples during the participant s surgery. These will be fat tissue and skeletal muscle tissue. Muscle tissue will only be taken from tissue that is going to be discarded. Collecting the tissue will not add any time or any extra incisions than what is required for the surgery. After surgery, blood will be drawn. Some participants will have this done in the pre-op or post-op room. Others will have this done during their hospital stay.

Conditions

Phenotyping; Brown Adipocytes; Brown Adipose Tissue (BAT) Physiology

Keywords

Phenotype; Adipose Tissue; Brown Adipose Tissue; Natural History

Outcome Measures

Primary Outcomes (3)

• Establish a comprehensive genetic and functional map of human brown and white adipose tissue.

  To understand the physiology of human BAT and its role in metabolism.

  tissue is collected the day of procedure/surgery

• Determine which anthropometric and genetic factors influence the growth and function of human BAT.

  To understand the physiology of human BAT and its role in metabolism.

  tissue is collected the day of procedure/surgery

• Identify factors within adipose tissue and plasma that (a) stimulate BAT growth and/or activity and/or (b) are released by BAT to regulate metabolism.

  To understand the physiology of human BAT and its role in metabolism.

  tissue is collected the day of procedure/surgery

Study Arms (2)

Healthy Volunteers

Individuals known to have brown adipose tissue, identified by PET/CT following participation/scanning in other clinical studies

Surgical Patients

Individuals undergoing planned, clinically-indicated surgeries

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two cohorts will be studied in this protocol, patients undergoing clinically-indicated surgery (Cohort 1) and healthy volunteers (Cohort 2).

You may not qualify if:

• Male or female
• Any ethnicity
• years or older
• Subject undergoing planned, clinically-indicated surgical procedure at the NIH Clinical Center in which tissue will be accessible and available for collection by the Operating Surgeon.
• Inability to provide consent.
• Pregnancy
• Male or female
• Any ethnicity
• year
• For supraclavicular or dorsocervical adipose biopsy: 18F-FDG PET/CT Scan images available in the CRC PACS system (performed as part of separate protocol)
• History of keloids.
• Currently taking blood thinning or anti-inflammatory medications including anti-platelet or antithrombotic medications.
• Pregnancy
• History of pacemaker, metallic heart valves, aneurysm clip, pedicle screws, metallic foreign body in eye, or other metallic implant only if using fusion technology for the biopsy procedure.
• Psychological conditions including (but not limited to) clinical depression, bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Aaron M Cypess, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley M Schmitz, C.R.N.P.

CONTACT

(920) 948-1186; ashley.schmitz@nih.gov

Aaron M Cypess, M.D.

CONTACT

(301) 435-9267; aaron.cypess@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: February 26, 2016
• Study Start: March 22, 2016
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: With whom - Researchers who provide a methodologically sound proposal@@@@@@@@@@@@For what types of analysis - To achieve aims in the approved proposal.@@@@@@@@@@@@By what mechanism will data be made available? - Proposals should be directed to aaron.cypess@nih.gov. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)