Recruiting

Metabolism Research

Sponsor:

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

Code:

NCT02692885

Conditions

Brown Adipose Tissue (BAT) Physiology

Phenotyping

Brown Adipocytes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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

Brown Adipose Tissue (BAT) Physiology

Phenotyping

Brown Adipocytes

Study ID

NCT02692885

Start date

Mar 22, 2016

Status verified date

Jul 29, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION/EXCLUSION CRITERIA FOR SUBJECTS UNDERGOING SURGERY (COHORT 1)

INCLUSION CRITERIA:

  • Male or female
  • Any ethnicity
  • 18 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.

EXCLUSION CRITERIA:

  • Inability to provide consent.
  • Pregnancy

INCLUSION/EXCLUSION CRITERIA FOR ALL OTHER SUBJECTS (HEALTHY VOLUNTEERS AND NON-SURGICAL PATIENTS (COHORT 2):

INCLUSION CRITERIA:

  • Male or female
  • Any ethnicity
  • 18-80 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)

EXCLUSION CRITERIA:

  • 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.
  • Addiction to alcohol or substances of abuse within the last 5 years; current use of drugs or alcohol (CAGE greater than or equal to 2).
  • Inability to provide consent.

All subjects will be fully informed of the aims, nature, and risks of the study prior to giving written informed consent.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Establish a comprehensive genetic and functional map of human brown and white adipose tissue. [ Time Frame: tissue is collected the day of procedure/surgery ]
  • Determine which anthropometric and genetic factors influence the growth and function of human BAT. [ Time Frame: 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. [ Time Frame: tissue is collected the day of procedure/surgery ]

Central Contacts and Locations

Central contacts

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

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

Aaron M Cypess, M.D.

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

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

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

Last update posted

Jul 31, 2026

Last verified

Jul 29, 2026

Keywords

  • Phenotype
  • Adipose Tissue
  • Brown Adipose Tissue
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-07-31.