NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-DK-0068

Sponsoring Institute

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

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Phenotype;
Adipose Tissue;
Brown Adipose Tissue

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

--Back to Top--

Eligibility

IINCLUSION/EXCLUSION CRITERIA FOR SUBJECTS UNDERGOING SURGERY (COHORT 1)

-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:

-None

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

-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).

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


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Aaron M. Cypess, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)



Ashley M. Schmitz, C.R.N.P.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10-CRC RM 6-3940
10 CENTER DR
BETHESDA MD 20814
(301) 827-5259
ashley.schmitz@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02692885

--Back to Top--