ObesityNCT02346474
Cross Calibration of Two Dual Energy Densitometers and Comparison of Regional Adipose Tissue Measurements by iDXA and MRI
An observational study of Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: It is important for doctors to know how much fat a person has in his or her body. Machines called DXAs measure how much fat mass and fat-free mass a person has. Researchers in this study have a new DXA machine, and they want to know if it measures body fat as well as the old machine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2015to 31 Mar 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: greater than or equal to 18 years old
- Individuals will be recruited to represent a broad range of BMI such that approximately equal numbers of men and women in BMI groups of < 25 kg/m(2), greater than or equal to 25 kg/m(2)-<30 kg/m(2), and greater than or equal to 30kg/m(2) are represented.
- NIH employees will be allowed to participate
Who cannot join
- Individuals who, based on their radiation history and by our local radiation exposure reports, would exceed the safety limits imposed by current Phoenix Radiation Safety Committee radiation safety guidelines.
- Pregnant females, due to exposure to research related radiation in this study
- Presence of a pacemaker or other implantable devices/shrapnel which may interfere with the MRI scan.
- Central nervous system disease ( such as cerebrovascular accidents, dementia, and neurodegenerative disorders) which preclude individuals from being able to provide informed consent.
- Current or past history of: bipolar disorder, schizophrenia or presence of psychotic symptoms, bulimia nervosa or anorexia nervosa, or current major depressive disorder which preclude individuals from being able to provide informed consent.
- Weight > 350 pounds (limit of currently used DXA scan)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross Calibration of Two Dual Energy Densitometers and Comparison of Regional Adipose Tissue Measurements by iDXA and MRI.
Background:
- It is important for doctors to know how much fat a person has in his or her body. Machines called DXAs measure how much fat mass and fat-free mass a person has. Researchers in this study have a new DXA machine, and they want to know if it measures body fat as well as the old machine. They also want to see how body fat readings from the new DXA compare to readings from a magnetic resonance imaging (MRI) scan.
Read more
Objectives:
- To see if two DXA machines give the same results when measuring body fat. Also, to know whether the DXA and MRI give the same results in measuring visceral and subcutaneous fat.
Eligibility:
- People 18 years and older who weigh less than 350 pounds.
Design:
- Participants will be screened with a medical history and physical exam. Women will have a pregnancy test. Researchers will make sure participants are able to have an MRI if they volunteered to.
- Participants will have their body fat measured by each DXA scanner. They will lie quietly on a padded table while being scanned. The scan uses X-rays to take pictures of the body. Both scans will be done on the same morning and will take 10-15 minutes on both machines.
- Some participants also will have their body fat measured with MRI. They will lie in a long, tube-shaped scanner. The machine uses strong magnetic fields and radio waves to take pictures of internal organs. Participants will sign an additional consent form for this procedure.
Read the detailed description
Our Research unit (NIDDK) recently acquired a new x-ray unit (the General Electric (GE) Lunar iDXA) for measurement of body composition (how much fat someone has as a percent of their weight). This machine provides clearer and crisper images. The unit also has a larger table to allow patients up to 450 lbs (204 kg) to be scanned. The larger table allows for easier positioning of tall and heavy patients. We would like to use this new machine in the future but want to see whether our current DXA unit (the Lunar Prodigy Densitometer by GE) and the Lunar iDXA Densitometer (GE) measure the same percentage of a person s body fat. If there are measurement differences between the two machines, we will develop a way to convert the new results to more closely match the results from the current DXA unit. Thus, in this study, we will be asking volunteers to undergo scanning for measurement of body fat on both machines on the same day.
Fat within the belly which is around organs (called visceral fat or VAT) is linked to more bad health outcomes than fat which is just underneath the skin (called subcutanoues fat or SAT). Along with standardizing the DXA - body composition measurement results we would like to compare VAT and SAT estimates from iDXA with values obtained by MRI. The precise MRI measurements completely avoid radiation exposure for the volunteers but are far more time consuming. Knowing that the results of iDXA match up with or correlate with the MRI results would allow us to use iDXA measurements to estimate visceral and subcutaneous adipose tissue depots in ongoing and the future studies.
- Conditions
- Obesity
- Keywords
- Subcutaneous Fat, Visceral Fat
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of body fat measurements
Measured: 1 year
Secondary outcomes (1)
Comparison of DXA and MRI visceral fat
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study start24 Jan 2015
- Primary completion28 Jul 2016
- Study completion31 Mar 2020
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jonathan Krakoff, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346474
- Sponsor's protocol ID
- 999915054
- Other IDs
- 15-DK-N054
- Status last verified
- Apr 2020
- First submitted
- 24 Jan 2015
- Last updated
- 7 Apr 2020
- Results posted
- No
Publications
Reinhardt M, Piaggi P, DeMers B, Trinidad C, Krakoff J. Cross calibration of two dual-energy X-ray densitometers and comparison of visceral adipose tissue measurements by iDXA and MRI. Obesity (Silver Spring). 2017 Feb;25(2):332-337. doi: 10.1002/oby.21722. Epub 2016 Dec 21.
PubMed 28000375
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Calibration of Two Dual Energy Densitometers and Comparison of Regional Adipose Tissue Measurements by iDXA and MRI.
- ClinicalTrials.gov ID
- NCT02346474
- Acronym / sponsor ID
- 999915054
- Conditions
- Obesity
- Keywords
- Subcutaneous Fat, Visceral Fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 24 Jan 2015 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 27 Jan 2015 (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.
Background:
- It is important for doctors to know how much fat a person has in his or her body. Machines called DXAs measure how much fat mass and fat-free mass a person has. Researchers in this study have a new DXA machine, and they want to know if it measures body fat as well as the old machine. They also want to see how body fat readings from the new DXA compare to readings from a magnetic resonance imaging (MRI) scan.
Objectives:
- To see if two DXA machines give the same results when measuring body fat. Also, to know whether the DXA and MRI give the same results in measuring visceral and subcutaneous fat.
Eligibility:
- People 18 years and older who weigh less than 350 pounds.
Design:
- Participants will be screened with a medical history and physical exam. Women will have a pregnancy test. Researchers will make sure participants are able to have an MRI if they volunteered to.
- Participants will have their body fat measured by each DXA scanner. They will lie quietly on a padded table while being scanned. The scan uses X-rays to take pictures of the body. Both scans will be done on the same morning and will take 10-15 minutes on both machines.
- Some participants also will have their body fat measured with MRI. They will lie in a long, tube-shaped scanner. The machine uses strong magnetic fields and radio waves to take pictures of internal organs. Participants will sign an additional consent form for this procedure.
Detailed description
Our Research unit (NIDDK) recently acquired a new x-ray unit (the General Electric (GE) Lunar iDXA) for measurement of body composition (how much fat someone has as a percent of their weight). This machine provides clearer and crisper images. The unit also has a larger table to allow patients up to 450 lbs (204 kg) to be scanned. The larger table allows for easier positioning of tall and heavy patients. We would like to use this new machine in the future but want to see whether our current DXA unit (the Lunar Prodigy Densitometer by GE) and the Lunar iDXA Densitometer (GE) measure the same percentage of a person s body fat. If there are measurement differences between the two machines, we will develop a way to convert the new results to more closely match the results from the current DXA unit. Thus, in this study, we will be asking volunteers to undergo scanning for measurement of body fat on both machines on the same day.
Fat within the belly which is around organs (called visceral fat or VAT) is linked to more bad health outcomes than fat which is just underneath the skin (called subcutanoues fat or SAT). Along with standardizing the DXA - body composition measurement results we would like to compare VAT and SAT estimates from iDXA with values obtained by MRI. The precise MRI measurements completely avoid radiation exposure for the volunteers but are far more time consuming. Knowing that the results of iDXA match up with or correlate with the MRI results would allow us to use iDXA measurements to estimate visceral and subcutaneous adipose tissue depots in ongoing and the future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (6 listed)
- Individuals who, based on their radiation history and by our local radiation exposure reports, would exceed the safety limits imposed by current Phoenix Radiation Safety Committee radiation safety guidelines.
- Pregnant females, due to exposure to research related radiation in this study
- Presence of a pacemaker or other implantable devices/shrapnel which may interfere with the MRI scan.
- Central nervous system disease ( such as cerebrovascular accidents, dementia, and neurodegenerative disorders) which preclude individuals from being able to provide informed consent.
- Current or past history of: bipolar disorder, schizophrenia or presence of psychotic symptoms, bulimia nervosa or anorexia nervosa, or current major depressive disorder which preclude individuals from being able to provide informed consent.
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
Comparison of body fat measurements
Time frame: 1 year
1 secondary outcome
Comparison of DXA and MRI visceral fat
Time frame: 1 year
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 7 Apr 2020.
- Derived from this study: PubMed 28000375Reinhardt M, Piaggi P, DeMers B, Trinidad C, Krakoff J. Cross calibration of two dual-energy X-ray densitometers and comparison of visceral adipose tissue measurements by iDXA and MRI. Obesity (Silver Spring). 2017 Feb;25(2):332-337. doi: 10.1002/oby.21722. Epub 2016 Dec 21.
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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.
Jonathan Krakoff, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 3 inclusion and 6 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 7 Apr 2020. 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?
Comparison of body fat measurements (time frame: 1 year). 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 NCT02346474, 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 7 Apr 2020.