HIV/AIDSNCT07203261
Comparison of the Body Roundness Index and A Body Shape Index With Body Fat and Visceral Fat in People Living With HIV.
An observational study of HIV/AIDS, run by Queens College, The City University of New York at 1 site in United States.
Trial summary
The study compares the Body Roundness Index (BRI) and the A Body Shape Index (ABSI) with with body fat and visceral fat in people living with HIV. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV/AIDS
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People living with HIV
Who may be able to join
- Diagnosed with HIV
- Receiving the same anti-retroviral therapy for >= 6 months.
Who cannot join
- Pregnancy
- Having an implantable cardioverters or pacemakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Applied Physiology Laboratory
Flushing, New York, 11367
About this study
Official title: Comparison of the Body Roundness Index and A Body Shape Index With Body Fat and Visceral Fat in People Living With HIV: A Pilot Study
The study compares the Body Roundness Index (BRI) and the A Body Shape Index (ABSI) with with body fat and visceral fat in people living with HIV.
Read the detailed description
Obesity is among the most prevalent cardiometabolic issues in recent years among people living with HIV (PLWH), and this is especially true among those that initiate and continue to take ART. Even newer first-line ART medications like Integrase inhibitors are strongly associated with the development of obesity among PLWH. This is of particular importance since research shows that excess fat, especially excess fat in the abdominal region, is associated with mortality (Jayedi et al., 2022; Lee et al., 2018). However, fat distribution in PLWH taking ART may not follow the same pattern of fat distribution found in general population (Lamesa et al., 2014). PLWH taking ART often experience abnormal accumulation of fat in the trunk and abdominal region (i.e., lipohypertrophy) and wasting of fat in the hips and extremities (i.e., lipoatrophy), both which can happen together or separately.
The Body Roundness Index (BRI) and A Body Shape Index (ABSI) are simple non- invasive anthropometric methods used to evaluate body fat distribution in general population. These measures can be very useful since they are predictive of overall body fat and visceral adipose tissue (VAT), and they correlate with diabetes, insulin resistance, metabolic syndrome among other cardiometabolic issues. Further, among PLWH, the ABSI and BRI have been associated with cardiovascular risk in men. However, the relationship between these anthropometric measures with overall body fat and VAT has not been evaluated among PLWH. The complex and unique nature of the fat distribution in PLWH taking ART warrants further evaluation of the validity of these measures in this patient population.
The study is cross-sectional in design and will be completed in one session. Participants living with HIV who agree to participate will be asked to complete a sociodemographic and health history questionnaire, and will then have their height, weight, waist circumference and hip circumference measured to calculate their BRI and ABSI. Participants will also have their body fat and lean body mass measured through air displacement plethysmography (ADP) and through bioelectrical impedance analysis (BIA). Visceral adiposity will be measured through ultra sound.
- Conditions
- HIV/AIDS
- Keywords
- human immunodeficiency virus, Body composition
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV+ | Participants living with HIV (HIV+) will have their waist circumference, hip circumference , height and weight measured. Participants will also have their body fat and visceral adipose tissue measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Body Shape Index
The ABSI is a measure of the body shape and the concentration of body volume. The ABSI is defined as the waist circumference (WC) divided by the body mass index (BMI) raised to two-thirds and by the square root of the person's height. WC will be measured just above the uppermost lateral border of the ilium at the end of a normal exhalation as recommended by NHANES guidelines. BMI will be calculated as Weight (kilograms) / Height (meters)2. Height will be measured using a standard stadiometer. With the participants without shoes. The measure will be taken with their back towards the stadiometer, buttocks touching the measurement surface, feet flat and externally rotated 60 degrees. The participants head will be aligned so that the horizontal line from the ear canal to the lower border of the orbit of the eye is parallel to the floor. The measure will be taken at the end of normal exhalation. Weight will be measured with the participant wearing minimal clothing and no shoes.
Measured: At enrollment, on the first day of the protocol.
Body Roundness Index (BRI)
BRI is utilized to quantify the body shape of an individual using WC and height. WC will be measured just above the uppermost lateral border of the ilium at the end of a normal exhalation as recommended by NHANES guidelines. Height will be measured using a standard stadiometer. We will ask the participant to take off their shoes and stand with their back towards the stadiometer, with the buttocks touching the measurement surface at all times, feet flat and externally rotated approximately 60 degrees. Before taking the measurement we will align the participants head so that the horizontal line from the ear canal to the lower border of the orbit of the eye is parallel to the floor. The measure will be taken at the end of normal exhalation. Hip circumference will be measured at the widest part of the hip/buttocks area and will be added to increase the accuracy of the measure.
Measured: At enrollment, on the first day of the protocol.
Visceral Adipose Tissue (VAT)
Visceral adipose tissue. VAT will be evaluated using the GE Logiq V2 ultrasound device. This measure will be used to evaluate the relationship between ABSI and BRI with VAT. The validity of ultrasound for measuring VAT has been established. The measurement will be taken using a 8 MHz abdominal probe transducer with the participant in supine position at the end of normal exhalation. Water based gel will be applied to the participants abdomen before the test. The transducer will be placed vertically against the skin in the saggital plane and pressed as lightly as possible to minimize the compression of the abdominal region. The distance between the posterior linea alba and the peritoneum immediately below, and 1 centimeter to the right of, the xiphoid process will be scanned. The measurement will be reported in centimeters.
Measured: At enrollment, on the first day of the protocol.
Body fat (through bioelctrical impedance analysis; BIA)
Body fat will be measured using a Bioelectrical Impedance Analyzer (In body 770). The subject will stand on electrodes and grab a pair of electrodes. The test takes5 minutes and the analyzer is on for less than 1 minute. Body fat is calculated through the impedance or resistance of a low level electrical current passing through the body. Body fat percentage will be recorded.
Measured: At enrollment, on the first day of the protocol.
Body fat (through air displacement plethysmography; ADP)
Body far will be measured through whole-body air displacement plethysmography (ADP) with estimated thoracic gas volume. Before the measurement we will ask the participant to change into a body forming swim suit and a swim cap. Then, we will ask the participant to sit inside the ADP chamber without moving for a couple of minutes while the equipment takes the measurements. The participant should not be able to feel anything while sitting inside the chamber. Thoracic gas volume will also be measured. Body density (D) is calculated from body mass (M) and measured body volume (V) using the formula: D = M / V. Body fat is calculated using the Siri equation: % Fat = (4.95 / D) - 4.5.
Measured: At enrollment, on the first day of the protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start25 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queens College, The City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norberto Quiles, Queens College, The City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203261
- Sponsor's protocol ID
- TRADA-56-191
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Body Roundness Index and A Body Shape Index With Body Fat and Visceral Fat in People Living With HIV: A Pilot Study
- ClinicalTrials.gov ID
- NCT07203261
- Acronym / sponsor ID
- TRADA-56-191
- Conditions
- HIV/AIDS
- Keywords
- human immunodeficiency virus, Body composition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Queens College, The City University of New YorkUniversity, hospital or other
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- 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 study compares the Body Roundness Index (BRI) and the A Body Shape Index (ABSI) with with body fat and visceral fat in people living with HIV.
Detailed description
Obesity is among the most prevalent cardiometabolic issues in recent years among people living with HIV (PLWH), and this is especially true among those that initiate and continue to take ART. Even newer first-line ART medications like Integrase inhibitors are strongly associated with the development of obesity among PLWH. This is of particular importance since research shows that excess fat, especially excess fat in the abdominal region, is associated with mortality (Jayedi et al., 2022; Lee et al., 2018). However, fat distribution in PLWH taking ART may not follow the same pattern of fat distribution found in general population (Lamesa et al., 2014). PLWH taking ART often experience abnormal accumulation of fat in the trunk and abdominal region (i.e., lipohypertrophy) and wasting of fat in the hips and extremities (i.e., lipoatrophy), both which can happen together or separately.
The Body Roundness Index (BRI) and A Body Shape Index (ABSI) are simple non- invasive anthropometric methods used to evaluate body fat distribution in general population. These measures can be very useful since they are predictive of overall body fat and visceral adipose tissue (VAT), and they correlate with diabetes, insulin resistance, metabolic syndrome among other cardiometabolic issues. Further, among PLWH, the ABSI and BRI have been associated with cardiovascular risk in men. However, the relationship between these anthropometric measures with overall body fat and VAT has not been evaluated among PLWH. The complex and unique nature of the fat distribution in PLWH taking ART warrants further evaluation of the validity of these measures in this patient population.
The study is cross-sectional in design and will be completed in one session. Participants living with HIV who agree to participate will be asked to complete a sociodemographic and health history questionnaire, and will then have their height, weight, waist circumference and hip circumference measured to calculate their BRI and ABSI. Participants will also have their body fat and lean body mass measured through air displacement plethysmography (ADP) and through bioelectrical impedance analysis (BIA). Visceral adiposity will be measured through ultra sound.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV+ | – | –Participants living with HIV (HIV+) will have their waist circumference, hip circumference , height and weight measured. Participants will also have their body fat and visceral adipose tissue measured. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV
Key inclusion criteria (2 listed)
- Diagnosed with HIV
- Receiving the same anti-retroviral therapy for >= 6 months.
Key exclusion criteria (2 listed)
- Pregnancy
- Having an implantable cardioverters or pacemakers
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
A Body Shape Index
Time frame: At enrollment, on the first day of the protocol.
The ABSI is a measure of the body shape and the concentration of body volume. The ABSI is defined as the waist circumference (WC) divided by the body mass index (BMI) raised to two-thirds and by the square root of the person's height. WC will be measured just above the uppermost lateral border of the ilium at the end of a normal exhalation as recommended by NHANES guidelines. BMI will be calculated as Weight (kilograms) / Height (meters)2. Height will be measured using a standard stadiometer. With the participants without shoes. The measure will be taken with their back towards the stadiometer, buttocks touching the measurement surface, feet flat and externally rotated 60 degrees. The participants head will be aligned so that the horizontal line from the ear canal to the lower border of the orbit of the eye is parallel to the floor. The measure will be taken at the end of normal exhalation. Weight will be measured with the participant wearing minimal clothing and no shoes.
Body Roundness Index (BRI)
Time frame: At enrollment, on the first day of the protocol.
BRI is utilized to quantify the body shape of an individual using WC and height. WC will be measured just above the uppermost lateral border of the ilium at the end of a normal exhalation as recommended by NHANES guidelines. Height will be measured using a standard stadiometer. We will ask the participant to take off their shoes and stand with their back towards the stadiometer, with the buttocks touching the measurement surface at all times, feet flat and externally rotated approximately 60 degrees. Before taking the measurement we will align the participants head so that the horizontal line from the ear canal to the lower border of the orbit of the eye is parallel to the floor. The measure will be taken at the end of normal exhalation. Hip circumference will be measured at the widest part of the hip/buttocks area and will be added to increase the accuracy of the measure.
Visceral Adipose Tissue (VAT)
Time frame: At enrollment, on the first day of the protocol.
Visceral adipose tissue. VAT will be evaluated using the GE Logiq V2 ultrasound device. This measure will be used to evaluate the relationship between ABSI and BRI with VAT. The validity of ultrasound for measuring VAT has been established. The measurement will be taken using a 8 MHz abdominal probe transducer with the participant in supine position at the end of normal exhalation. Water based gel will be applied to the participants abdomen before the test. The transducer will be placed vertically against the skin in the saggital plane and pressed as lightly as possible to minimize the compression of the abdominal region. The distance between the posterior linea alba and the peritoneum immediately below, and 1 centimeter to the right of, the xiphoid process will be scanned. The measurement will be reported in centimeters.
Body fat (through bioelctrical impedance analysis; BIA)
Time frame: At enrollment, on the first day of the protocol.
Body fat will be measured using a Bioelectrical Impedance Analyzer (In body 770). The subject will stand on electrodes and grab a pair of electrodes. The test takes5 minutes and the analyzer is on for less than 1 minute. Body fat is calculated through the impedance or resistance of a low level electrical current passing through the body. Body fat percentage will be recorded.
Body fat (through air displacement plethysmography; ADP)
Time frame: At enrollment, on the first day of the protocol.
Body far will be measured through whole-body air displacement plethysmography (ADP) with estimated thoracic gas volume. Before the measurement we will ask the participant to change into a body forming swim suit and a swim cap. Then, we will ask the participant to sit inside the ADP chamber without moving for a couple of minutes while the equipment takes the measurements. The participant should not be able to feel anything while sitting inside the chamber. Thoracic gas volume will also be measured. Body density (D) is calculated from body mass (M) and measured body volume (V) using the formula: D = M / V. Body fat is calculated using the Siri equation: % Fat = (4.95 / D) - 4.5.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
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 HIV/AIDS, run by Queens College, The City University of New York 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 2 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: opening soon, as of the sponsor's last update on 2 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norberto Quiles, Ed.D. (718-997-2718, norberto.quilesgonzalez@qc.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Body Shape Index (time frame: At enrollment, on the first day of the protocol.). The study lists 5 primary outcomes in all. 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 2 Oct 2025.