Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism (NCT02692885) | Clinical Trial Compass
RecruitingNot Applicable
Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
United States300 participantsStarted 2016-03-22
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Establish a comprehensive genetic and functional map of human brown and white adipose tissue.
Timeframe: tissue is collected the day of procedure/surgery
2
Determine which anthropometric and genetic factors influence the growth and function of human BAT.
Timeframe: tissue is collected the day of procedure/surgery
3
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.
Timeframe: tissue is collected the day of procedure/surgery
Trial details
NCT IDNCT02692885
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)