ObesityNCT01900366
Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity
An observational study of Obesity, run by Rockefeller University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fat Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteer and obese subjects
Who may be able to join
- -Subjects currently enrolled in a current Rockefeller University study who will be undergoing adipose tissue biopsies as part of the study protocol
Who cannot join
- -History of any skin disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Fat Biopsy
- Keywords
- Obesity, Healthy Volunteers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat BiopsyProcedure or surgery
Fat biopsy
| Study group | Role | What they receive |
|---|---|---|
| Obese subjects for fat biopsy | 10 patients recruited during fat biopsies for sample collection Receives: Procedure: Fat Biopsy | |
| Lean controls for fat biopsy | 5 Lean controls will be recruited Receives: Procedure: Fat Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy
Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy
Measured: 1 day
Secondary outcomes (1)
Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy
Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Jose Aleman, MD PhD, Principal investigator, Rockefeller Univesrity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900366
- Sponsor's protocol ID
- JAL-0809
- Status last verified
- Sep 2016
- First submitted
- 11 Jul 2013
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity
- ClinicalTrials.gov ID
- NCT01900366
- Acronym / sponsor ID
- JAL-0809
- Conditions
- Obesity
- Keywords
- Obesity, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- Aug 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese subjects for fat biopsy | – | Procedure: Fat Biopsy10 patients recruited during fat biopsies for sample collection |
| Lean controls for fat biopsy | – | Procedure: Fat Biopsy5 Lean controls will be recruited |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteer and obese subjects
Key inclusion criteria (1 listed)
- -Subjects currently enrolled in a current Rockefeller University study who will be undergoing adipose tissue biopsies as part of the study protocol
Key exclusion criteria (1 listed)
- -History of any skin disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat BiopsyFat biopsy | Procedure or surgery | Lean controls for fat biopsy, Obese subjects for fat biopsy |
Primary outcome
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 secondary outcome
Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Aleman, MD PhD principal investigator
Rockefeller Univesrity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.