Understanding how human fat and muscle affect metabolism
The Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
This study is trying to understand how fat and muscle in our bodies affect how we use energy, especially to see if brown fat can help fight obesity and related health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02692885 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of brown adipose tissue (BAT) and muscle in metabolism, particularly how they store and utilize energy. Researchers will collect tissue samples from adults undergoing planned surgeries at the NIH Clinical Center to analyze the physiological and genetic characteristics of these tissues. The study seeks to uncover the mechanisms by which BAT may help combat obesity and related metabolic diseases, potentially leading to new treatment strategies. Participants will not need to make additional visits to the NIH, as samples will be collected during their scheduled surgeries.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for clinically-indicated surgical procedures at the NIH Clinical Center.
Not a fit: Patients who are pregnant or have a history of certain medical conditions or metallic implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new treatments for obesity and metabolic diseases by enhancing our understanding of how brown fat functions.
How similar studies have performed: While the role of brown adipose tissue in metabolism is a relatively novel area of research, preliminary studies have shown promising results in understanding its potential benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Aaron M Cypess, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Ashley M Schmitz, C.R.N.P.
- Email: ashley.schmitz@nih.gov
- Phone: (920) 948-1186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.