ObesityNCT02205021
Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome
An observational study of Obesity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Accumulation of fat in the neck using tape measures has been linked to increased cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat using computed tomography will show that specific fat compartments in the neck contribute differently to cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 91 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2014
- 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 91 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retrospective search of whole-body PET/CT examinations and consecutively selected imaging studies.
Who may be able to join
- no history of malignancy at the time of image acquisition
- fasting glucose measured immediately prior to PET/CT
Who cannot join
- history of neck cancer, radiation therapy, and/or surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Compartmental Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome
Accumulation of fat in the neck using tape measures has been linked to increased cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat using computed tomography will show that specific fat compartments in the neck contribute differently to cardiovascular risk.
- Conditions
- Obesity
- Being tested
- No intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship of specific neck compartments to cardiovascular risk
Cardiovascular risk measures were obtained within one year of CT imaging of the neck.
Measured: 1 year between PET/CT and cardiometabolic marker measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torriani, Martin,M.D., Massachusetts General Hospital
- Investigators
- Martin Torriani, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205021
- Sponsor's protocol ID
- 2012P001603
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2014
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Torriani M, Gill CM, Daley S, Oliveira AL, Azevedo DC, Bredella MA. Compartmental neck fat accumulation and its relation to cardiovascular risk and metabolic syndrome. Am J Clin Nutr. 2014 Nov;100(5):1244-51. doi: 10.3945/ajcn.114.088450. Epub 2014 Sep 3.
PubMed 25332322
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compartmental Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02205021
- Acronym / sponsor ID
- 2012P001603
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- First posted
- 31 Jul 2014 (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.
Accumulation of fat in the neck using tape measures has been linked to increased cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat using computed tomography will show that specific fat compartments in the neck contribute differently to cardiovascular risk.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 91 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective search of whole-body PET/CT examinations and consecutively selected imaging studies.
Key inclusion criteria (2 listed)
- no history of malignancy at the time of image acquisition
- fasting glucose measured immediately prior to PET/CT
Key exclusion criteria (1 listed)
- history of neck cancer, radiation therapy, and/or surgery
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 |
|---|---|---|
| No intervention | Other | All subjects |
Primary outcome
Relationship of specific neck compartments to cardiovascular risk
Time frame: 1 year between PET/CT and cardiometabolic marker measures
Cardiovascular risk measures were obtained within one year of CT imaging of the neck.
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 31 Jul 2014.
- Derived from this study: PubMed 25332322Torriani M, Gill CM, Daley S, Oliveira AL, Azevedo DC, Bredella MA. Compartmental neck fat accumulation and its relation to cardiovascular risk and metabolic syndrome. Am J Clin Nutr. 2014 Nov;100(5):1244-51. doi: 10.3945/ajcn.114.088450. Epub 2014 Sep 3.
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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.
Martin Torriani, M.D. principal investigator
Massachusetts General Hospital
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 Massachusetts General Hospital 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 31 Jul 2014. 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?
Relationship of specific neck compartments to cardiovascular risk (time frame: 1 year between PET/CT and cardiometabolic marker measures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02205021, which also lists 1 linked publication.
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 31 Jul 2014.