NCT01228968

Brief Summary

Subjects will undergo a brief magnetic resonance (MRI) scan. The resulting images will be used to compare two abdominal fat segmentation techniques. The first technique is already validated and in use. The second technique was recently developed and has not been validated. The hypothesis is that the second technique will be the faster and more reliable of the two.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 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

Study Start

First participant enrolled

October 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 6, 2011

Completed
Last Updated

July 11, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

October 25, 2010

Results QC Date

April 11, 2011

Last Update Submit

June 13, 2018

Conditions

Keywords

obesity

Outcome Measures

Primary Outcomes (2)

  • Visceral Fat Volume With Automated Analysis

    This is the measurement of Abdominal Visceral Fat in cubic centimeters as determined with a new automated segmentation program.

    five minutes

  • Visceral Fat Volume With Manual Segmentation

    This is the measure of visceral fat found with our older manual segmentation method

    five minutes

Secondary Outcomes (2)

  • Subcutaneous Fat Volume With Automated Analysis

    five minutes

  • Subcutaneous Fat Volume With Manual Segmentation

    five minutes

Study Arms (1)

Volunteers

Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.

Eligibility Criteria

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

Subjects will have a wide range of body mass index and other physical characteristics.

You may qualify if:

  • ambulatory
  • cognitively sound

You may not qualify if:

  • body mass index less than 18 or greater than 45 kilograms per square meter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Gary Skolnick
Organization
Washington University School of Medicine

Study Officials

  • Samuel Klein, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 27, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 11, 2018

Results First Posted

May 6, 2011

Record last verified: 2018-06

Locations