NCT02346474

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 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

First Submitted

Initial submission to the registry

January 24, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

January 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2016

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

January 24, 2015

Last Update Submit

April 6, 2020

Conditions

Obesity

Keywords

Subcutaneous FatVisceral Fat

Outcome Measures

Primary Outcomes (1)

  • Comparison of body fat measurements

    1 year

Secondary Outcomes (1)

  • Comparison of DXA and MRI visceral fat

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (1)

  • 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.

    PMID: 28000375DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jonathan Krakoff, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2015

First Posted

January 27, 2015

Study Start

January 24, 2015

Primary Completion

July 28, 2016

Study Completion

March 31, 2020

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

US(1)