ObesityNCT01228968
Toward an Automated Method of Abdominal Fat Segmentation of MR Images
An observational study of Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Feb 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Subjects will have a wide range of body mass index and other physical characteristics.
Who may be able to join
- ambulatory
- cognitively sound
Who cannot join
- body mass index less than 18 or greater than 45 kilograms per square meter
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
- Conditions
- Obesity
- Keywords
- obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: five minutes
Visceral Fat Volume With Manual Segmentation
This is the measure of visceral fat found with our older manual segmentation method
Measured: five minutes
Secondary outcomes (2)
Subcutaneous Fat Volume With Automated Analysis
This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with new automated anatomical segmentation software.
Measured: five minutes
Subcutaneous Fat Volume With Manual Segmentation
This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with the older manual segmentation technique.
Measured: five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228968
- Sponsor's protocol ID
- MRImethods060229
- Status last verified
- Jun 2018
- First submitted
- 25 Oct 2010
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward an Automated Method of Abdominal Fat Segmentation of MR Images
- ClinicalTrials.gov ID
- NCT01228968
- Acronym / sponsor ID
- MRImethods060229
- Conditions
- Obesity
- Keywords
- obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will have a wide range of body mass index and other physical characteristics.
Key inclusion criteria (2 listed)
- ambulatory
- cognitively sound
Key exclusion criteria (1 listed)
- body mass index less than 18 or greater than 45 kilograms per square meter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visceral Fat Volume With Automated Analysis
Time frame: five minutes
This is the measurement of Abdominal Visceral Fat in cubic centimeters as determined with a new automated segmentation program.
Visceral Fat Volume With Manual Segmentation
Time frame: five minutes
This is the measure of visceral fat found with our older manual segmentation method
2 secondary outcomes
Subcutaneous Fat Volume With Automated Analysis
Time frame: five minutes
Subcutaneous Fat Volume With Manual Segmentation
Time frame: five minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Samuel Klein, M.D. principal investigator
Washington University School of Medicine
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 Washington University School of Medicine 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 2 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 11 Jul 2018. 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?
Yes. Results are posted in the registry (first posted 6 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visceral Fat Volume With Automated Analysis (time frame: five minutes). The study lists 2 primary outcomes in all. 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 11 Jul 2018.