ObesityNCT01110161
Technical Validation of Lunar iDXA Visceral Fat Tool
An observational study of Obesity, run by GE Healthcare at 1 site in China.
Trial summary
The goal of this project is to compare visceral fat measurements derived from Lunar iDXA total body scans and from Computed Tomography (CT) scans of the abdominal region for a Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Visceral fat mass measurement
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Nov 2010
- 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
Study population: Ages 18 and up, BMI between 18.5 and 40
Who may be able to join
- Age: 18 +
- BMI: 18.5 - 40
- Subject willing to provide informed consent
Who cannot join
- Subject who is affected by any diagnosed eating disorder
- Pregnancy
- Subject who is unable or unwilling to give consent
- Subjects who may not be good trial participants based on investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to compare visceral fat measurements derived from Lunar iDXA total body scans and from Computed Tomography (CT) scans of the abdominal region for a Chinese population.
Read the detailed description
Obesity is one of the greatest public health challenges of the 21st century. The World Health Organization (WHO) estimates for 2005 indicate approximately 1.6 billion adults are overweight (body mass index (BMI) > 25 kg/m2), with 400 million being characterized as obese (BMI > 30 kg/m2). By 2015, the WHO projections predict that the populations of overweight and obese adults will increase to 2.3 billion and 700 million respectively. The major determinant of obesity is the energy imbalance between calorie intakes and expenditures, which can be ascribed to a global dietary shift in favor of energy-dense foods particularly rich in fat and carbohydrates, and a global trend towards sedentary behaviors.
Body fat distribution and abdominal fat in particular is correlated with increased risk of cardiovascular disease, diabetes, hypertension, nonalcoholic fatty liver disease, cancer, and total mortality. It is therefore important to develop minimally invasive clinical tools to assess visceral fat. Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) represent the gold standards for the quantification of visceral and abdominal fat. However, the analytical cost and the limited availability of these instruments for large-scale screenings have encouraged the development of alternative methods based on cost effective and widely distributed technologies. Dual-energy x-ray absorptiometry (DXA) is a promising technology to fill this gap. DXA is being used increasingly as a rapid, precise, and accurate method for measurement of regional and total body composition in both clinical and research settings. Total body assessment using DXA provides a unique capability of non-invasive measurement of skeletal bone status, as well as lean and fat tissue components including percent fat, lean tissue mass, and the android (waist)/gynoid (hip) fat ratio. The DXA technology is well suited to large-scale screening for assessing body composition and fat distribution as a part of a global assessment of metabolic status.
A recent study of a cross-sectional sample of 5440 US adults participating in the NHANES surveys 1999-2004 showed that 29.2% of obese men and 35.4% of obese women (a total of approximately 19.5 million US adults) are metabolically healthy, (sometimes referred to as "uncomplicated" obesity), whereas 30.1% of normal-weight men and 21.1% of normal-weight women (a total of approximately 16.3 million US adults) exhibit clustering of two or more cardiometabolic abnormalities. This study concluded that additional research is required to understand the physiological mechanisms underlying these differences. Another recent study of more than 3000 participants drawn from the Framingham Heart Study showed that both subcutaneous fat and visceral fat were correlated with metabolic risk factors. However, only the effects of visceral fat remain significant after adjusting for common anthropometric indices such as waist circumference and BMI. The issues surrounding cardiometabolic risk among different phenotypes along with the increased risks associated with visceral fat suggests the need to measure visceral adipose tissue in a diverse population.The gold standard, CT, is not a practical solution due to the cost and radiation exposure associated with the measurement. Therefore, it is important to develop a low-cost, low-radiation screening method for measuring visceral adipose tissue.
The present study aims at measuring abdominal fat distribution (CT scan and Lunar iDXA) in 120 adults. These data provide the possibility to validate a new method for measuring abdominal fat distribution (visceral versus subcutaneous fat) against the gold standard, CT. If validated, such a protocol based on Lunar iDXA could offer a rapid and cost effective diagnostic tool for fat distribution assessment of individuals as a basis for future personalized and health care programs.
- Conditions
- Obesity
- Being tested
- Visceral fat mass measurement
- Keywords
- Abdominal Fat, Visceral Fat, Subcutaneous Fat, Dual-energy x-ray absorptiometry, DXA, Computed Tomography, CT, Body Mass Index, Body composition, Percent fat, Waist circumference, Hip circumference
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral fat mass measurementDevice
Also called Lunar iDXA (GE Healthcare)
Total body DXA measurement, Abdominal CT scan
| Study group | Role | What they receive |
|---|---|---|
| Visceral fat mass | The study population will include Chinese adult men and women, over the age of 18 years. All subjects will be recruited at Fudan University. Subjects will represent a wide range of BMI values (18.5 - 40 kg/m2). Receives: Device: Visceral fat mass measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between Lunar iDXA and CT measured visceral fat of the abdominal region
Measured: Both measurements made during initial visit, on the same day; no follow-up or additional procedures. Analysis of results to be completed within 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xin Gao, MD, Principal investigator, Shanghai Zhongshan HospitalDavid Ergun, PhD, Study director, GE Healthcare Lunar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110161
- Sponsor's protocol ID
- Fudan-2009-04
- Status last verified
- Dec 2010
- First submitted
- 25 Mar 2010
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Validation of Lunar iDXA Visceral Fat Tool
- ClinicalTrials.gov ID
- NCT01110161
- Acronym / sponsor ID
- Fudan-2009-04
- Conditions
- Obesity
- Keywords
- Abdominal Fat, Visceral Fat, Subcutaneous Fat, Dual-energy x-ray absorptiometry, DXA, Computed Tomography, CT, Body Mass Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Apr 2010 (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.
The goal of this project is to compare visceral fat measurements derived from Lunar iDXA total body scans and from Computed Tomography (CT) scans of the abdominal region for a Chinese population.
Detailed description
Obesity is one of the greatest public health challenges of the 21st century. The World Health Organization (WHO) estimates for 2005 indicate approximately 1.6 billion adults are overweight (body mass index (BMI) > 25 kg/m2), with 400 million being characterized as obese (BMI > 30 kg/m2). By 2015, the WHO projections predict that the populations of overweight and obese adults will increase to 2.3 billion and 700 million respectively. The major determinant of obesity is the energy imbalance between calorie intakes and expenditures, which can be ascribed to a global dietary shift in favor of energy-dense foods particularly rich in fat and carbohydrates, and a global trend towards sedentary behaviors.
Body fat distribution and abdominal fat in particular is correlated with increased risk of cardiovascular disease, diabetes, hypertension, nonalcoholic fatty liver disease, cancer, and total mortality. It is therefore important to develop minimally invasive clinical tools to assess visceral fat. Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) represent the gold standards for the quantification of visceral and abdominal fat. However, the analytical cost and the limited availability of these instruments for large-scale screenings have encouraged the development of alternative methods based on cost effective and widely distributed technologies. Dual-energy x-ray absorptiometry (DXA) is a promising technology to fill this gap. DXA is being used increasingly as a rapid, precise, and accurate method for measurement of regional and total body composition in both clinical and research settings. Total body assessment using DXA provides a unique capability of non-invasive measurement of skeletal bone status, as well as lean and fat tissue components including percent fat, lean tissue mass, and the android (waist)/gynoid (hip) fat ratio. The DXA technology is well suited to large-scale screening for assessing body composition and fat distribution as a part of a global assessment of metabolic status.
A recent study of a cross-sectional sample of 5440 US adults participating in the NHANES surveys 1999-2004 showed that 29.2% of obese men and 35.4% of obese women (a total of approximately 19.5 million US adults) are metabolically healthy, (sometimes referred to as "uncomplicated" obesity), whereas 30.1% of normal-weight men and 21.1% of normal-weight women (a total of approximately 16.3 million US adults) exhibit clustering of two or more cardiometabolic abnormalities. This study concluded that additional research is required to understand the physiological mechanisms underlying these differences. Another recent study of more than 3000 participants drawn from the Framingham Heart Study showed that both subcutaneous fat and visceral fat were correlated with metabolic risk factors. However, only the effects of visceral fat remain significant after adjusting for common anthropometric indices such as waist circumference and BMI. The issues surrounding cardiometabolic risk among different phenotypes along with the increased risks associated with visceral fat suggests the need to measure visceral adipose tissue in a diverse population.The gold standard, CT, is not a practical solution due to the cost and radiation exposure associated with the measurement. Therefore, it is important to develop a low-cost, low-radiation screening method for measuring visceral adipose tissue.
The present study aims at measuring abdominal fat distribution (CT scan and Lunar iDXA) in 120 adults. These data provide the possibility to validate a new method for measuring abdominal fat distribution (visceral versus subcutaneous fat) against the gold standard, CT. If validated, such a protocol based on Lunar iDXA could offer a rapid and cost effective diagnostic tool for fat distribution assessment of individuals as a basis for future personalized and health care programs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visceral fat mass | – | Device: Visceral fat mass measurementThe study population will include Chinese adult men and women, over the age of 18 years. All subjects will be recruited at Fudan University. Subjects will represent a wide range of BMI values (18.5 - 40 kg/m2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ages 18 and up, BMI between 18.5 and 40
Key inclusion criteria (3 listed)
- Age: 18 +
- BMI: 18.5 - 40
- Subject willing to provide informed consent
Key exclusion criteria (4 listed)
- Subject who is affected by any diagnosed eating disorder
- Pregnancy
- Subject who is unable or unwilling to give consent
- Subjects who may not be good trial participants based on investigator's discretion
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 |
|---|---|---|
| Visceral fat mass measurementAlso: Lunar iDXA (GE Healthcare)Total body DXA measurement, Abdominal CT scan | Device | Visceral fat mass |
Primary outcome
Agreement between Lunar iDXA and CT measured visceral fat of the abdominal region
Time frame: Both measurements made during initial visit, on the same day; no follow-up or additional procedures. Analysis of results to be completed within 3 months.
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 8 Dec 2010.
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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.
Xin Gao, MD principal investigator
Shanghai Zhongshan Hospital
David Ergun, PhD study director
GE Healthcare Lunar
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 GE Healthcare at 1 site in China.
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 4 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 8 Dec 2010. 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 China. 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?
Agreement between Lunar iDXA and CT measured visceral fat of the abdominal region (time frame: Both measurements made during initial visit, on the same day; no follow-up or additional procedures. Analysis of results to be completed within 3 months.). 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 8 Dec 2010.