NCT01900366

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

July 11, 2013

Last Update Submit

September 16, 2016

Conditions

Obesity

Keywords

ObesityHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy

    Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy

    1 day

Secondary Outcomes (1)

  • Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy

    1 day

Study Arms (2)

Obese subjects for fat biopsy

10 patients recruited during fat biopsies for sample collection

Procedure: Fat Biopsy

Lean controls for fat biopsy

5 Lean controls will be recruited

Procedure: Fat Biopsy

Interventions

Fat BiopsyPROCEDURE

Fat biopsy

Lean controls for fat biopsyObese subjects for fat biopsy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Volunteer and obese subjects

You may qualify if:

  • Subjects currently enrolled in a current Rockefeller University study who will be undergoing adipose tissue biopsies as part of the study protocol

You may not qualify if:

  • History of any skin disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Adipose tissue

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose Aleman, MD PhD

    Rockefeller Univesrity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 16, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations

US(1)