- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01900366
Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity
September 16, 2016 updated by: Rockefeller University
This study will test the potential of two techniques using light properties of adipose tissue to diagnose crown-like structures and inflammation to be compared with pathologic examination of adipose tissue biopsies from ongoing clinical studies.
Study Overview
Detailed Description
Adipose tissue (fat) inflammation is emerging as an important harbinger of disease development including Type 2 diabetes, heart disease and potentially cancer.
The hallmark feature of adipose tissue inflammation is the crown-like structure, a dying fat cell surrounded by immune cells attempting to clear the damage.
Current methods for detecting adipose tissue inflammation rely on invasive procedures such as fat biopsies.
We propose developing methods that use the light reflection properties of inflamed adipose tissue as a potential non-invasive method to detect adipose tissue inflammation.
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- The Rockefeller University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy Volunteer and obese subjects
Description
Inclusion Criteria:
-Subjects currently enrolled in a current Rockefeller University study who will be undergoing adipose tissue biopsies as part of the study protocol
Exclusion Criteria:
-History of any skin disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obese subjects for fat biopsy
10 patients recruited during fat biopsies for sample collection
|
Fat biopsy
|
Lean controls for fat biopsy
5 Lean controls will be recruited
|
Fat biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy
Time Frame: 1 day
|
Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy
Time Frame: 1 day
|
Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jose Aleman, MD PhD, Rockefeller Univesrity
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (ACTUAL)
August 1, 2016
Study Completion (ACTUAL)
August 1, 2016
Study Registration Dates
First Submitted
July 11, 2013
First Submitted That Met QC Criteria
July 11, 2013
First Posted (ESTIMATE)
July 16, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 19, 2016
Last Update Submitted That Met QC Criteria
September 16, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JAL-0809
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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