Cross Calibration of Two Dual Energy Densitometers and Comparison of Regional Adipose Tissue Measurements by iDXA and MRI



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:January 24, 2015
End Date:July 28, 2016

Use our guide to learn which trials are right for you!

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.

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.

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.

- INCLUSION CRITERIA:

1. Age range: greater than or equal to 18 years old

2. 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.

3. NIH employees will be allowed to participate

EXCLUSION CRITERIA:

1. 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.

2. Pregnant females, due to exposure to research related radiation in this study

3. Presence of a pacemaker or other implantable devices/shrapnel which may interfere with
the MRI scan.

4. Central nervous system disease ( such as cerebrovascular accidents, dementia, and
neurodegenerative disorders) which preclude individuals from being able to provide
informed consent.

5. 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.

6. Weight > 350 pounds (limit of currently used DXA scan)
We found this trial at
1
site
Phoenix, Arizona 85014
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials