Outcome of Body Composition Assessment in Patients With Severe Obesity Undergoing Metabolic Surgery
Conditions: Obesity
Sponsor: Pennington Biomedical Research Center

BCOM-Pilot
Protocol Version Date: 3/20/2026
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Protocol Title: Outcome of body composition assessment in patients with severe obesity 
undergoing metabolic surgery
Short Title: Body Composition Outcomes in MS patients (BCOMS)
PI Name: Zubaidah Nor Hanipah, MD
Sub-Investigator’s Name(s): 
Philip Schauer, MD
Vance Albaugh, MD
Steven Heysmfield, MD
Owen Carmichael, PhD
Laura Boyer, MSN, FNP-C
Hanim Ecem Diktas, PhD
Sri Devarakonda, PhD, RND
Protocol Version Date: 3/20/2026
IRB Review History
Revision 1.7
Objectives
The objective of this project is to generate pilot data substantiating our hypothesis that advanced body 
composition measurement tools will provide more accurate and clinically relevant data on the outcomes 
of metabolic surgery (MS) in patients with severe obesity compared to traditional methods.
To achieve this objective, we propose the following aims:
Aim 1: Evaluate the effectiveness of different body composition measurement tools in assessing 
outcomes in patients with severe obesity undergoing MS. We hypothesize that advanced body 
composition measurement tools will provide more accurate and clinically relevant data on the outcomes 
of MS in patients with severe obesity compared to traditional methods.
Aim 2: Assess the changes in body composition and muscle strength following MS. We 
hypothesize that 6 months post MS, patients will experience a reduction in muscle strength, along with 
a more significant decrease in fat mass compared to muscle mass.
Aim 3: Compare body compositions changes between SG and RYGB patients. We hypothesize 
that RYGB patients will experience greater reductions in subcutaneous, visceral, and total fat compared 
to SG patients after 6 months.
Background
Metabolic surgery (MS) is the most effective long term obesity treatment in patients with severe obesity1-
4. The prevalence of obesity among US adults is 40.3% and the prevalence of severe obesity is 9.4% 
(2021-2023)5-6. Despite the prevalence and severity of obesity, there is a significant knowledge gap 
regarding the most effective tools for assessing body composition in this population4. Traditional methods 
such as BMI and waist circumference may not accurately reflect changes in body composition, particularly 
 
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in patients with higher BMI. Current literature on body composition measurements in patients with severe 
obesity undergoing bariatric surgery is limited. 
Our study design and rationale are inspired by a 2003 study by Das et al.7, which assessed body 
composition using four measurement tools: the 3-compartment (3C) model, isotope dilution, 
densitometry, and BIA. This study involved 20 women with BMIs ranging from 37 to 76 who underwent 
RYGB. The findings indicated that a simple 3-compartment model using air displacement 
plethysmography and BIA is effective for clinical evaluation in this population. To date, this remains 
the only study focusing on higher BMI patients undergoing MS. However, its limitations include being 
conducted solely on a female population and using these four measurement tools exclusively in RYGB 
patients with severe obesity.
As mentioned earlier, the goal of this project is to generate pilot data substantiating our hypothesis that 
advanced body composition measurement tools will provide more accurate and clinically relevant data 
on the outcomes of MS in patients with severe obesity compared to traditional methods.
Inclusion and Exclusion Criteria
We will recruit 20 participants with severe obesity (BMI ≥ 40) who are scheduled to undergo MS. 
Overall, participants must be ambulatory, able to withstand lying flat (for MRI and DXA), stand without 
aid for 2 minutes, weighing less than 440 pounds. 
Inclusion and exclusion criteria are as follows:
Inclusion criteria:
•
Being either male or female
•
Being an adult greater or equal to 18 years of age
•
BMI ≥40 kg/m2
•
Weigh less than 440 pounds
•
Being willing to comply with the study procedures
•
Being scheduled for primary metabolic surgery (either Sleeve Gastrectomy or Roux-en-Y Gastric 
bypass)
Exclusion criteria:
•
Previous bariatric surgery or other complex abdominal surgery
•
Poorly controlled medical or psychiatric disorders 
•
For women in child-bearing ages, being pregnant or attempting to become pregnant or currently 
breastfeeding
•
Having metal-containing objects in their body that may cause artifact on MRI
•
Having medical implants such as a pacemaker or metal joint replacements
•
Having a body weight greater than 440 pounds
•
Comorbid conditions that may affect body composition measurements, such as advanced liver 
disease or severe cardiovascular disease.
•
Cannot understand risks, benefits, and compliance required to participate.
Number of Subjects
This is a single-center, non-randomized clinical trial to evaluate body composition outcomes in 
participants undergoing MS. The pilot study will recruit 20 participants with severe obesity undergoing 
MS. 
 
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We will attempt to recruit participants of all racial and ethnic backgrounds. The majority of our 
participants live in the area surrounding Baton Rouge. 
Equitable Selection of Participants: Individuals of either sex or individuals from any social class, are 
eligible to participate in the study if they are deemed acceptable candidates based on 
inclusion/exclusion criteria.
Recruitment Methods
The eligible and interested participants in the current study will be recruited at the Metamor Institute, 
PBRC. Participants should be scheduled for metabolic surgery prior to enrollment.
Once prospective participants are identified, the clinical research coordinator and/or study investigator 
will contact the potential participant and determine if the participant has any questions regarding the 
study and/or consent form. The participant’s medical history will be reviewed as well as determination 
of the subject meeting inclusion and exclusion criteria.
After determination of eligibility by the study staff, the participant will be scheduled for a study visit. An 
email copy or paper copy of the consent form will be provided to the subject that will subsequently be 
signed upon arrival on the first study day.
Upon arrival on the study day, the informed consent document will be signed, vital signs and body 
weight/body mass index confirmed. Pregnancy testing will be performed on women of childbearing 
potential per current PBRC policy.
Duration of Study Participation
Each participant will complete a single study visit that will take approximately 5 hours.
There will be a total of 2 study visits. The first visit will be before MS and the second visit will be 6 
months after surgery. 
Procedures
Visit #1 
(before 
surgery)
Visit #2
(6 months after 
surgery)
Informed Consent
X
Blood taking and urine testing (pregnancy test in 
women of childbearing age)
X
X
Vital sign 
X
X
Drink Deuterium then Bromide dilutions 
X
X
Dual-Energy X-ray Absorptiometry (DXA)
X
X
BodPod (Densitometry/ Air Displacement 
Plethysmography)
X
X
Complete diet, eating habit and physical activity 
questionnaires
X
X
3D Optical imaging
X
X
Waist Circumferences measurement 
X
X
Six-minute Walk
X
X
Leg strength and endurance
X
X
Collect blood samples at 4 hours post (Deuterium 
then Bromide dilutions)
X
X
Bioimpedance Analysis (BIA)
X
X
Abdomen, Pelvis and Thigh MRI 
X
X
 
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Pre-visit requirements: 
Participants will fast at least 8 hours prior to their study. Participants will not exercise, shower, or use 
steam rooms or saunas at least two hours before evaluation.
Participants will bring their own form-fitting clothing attire that does not have metal- containing objects, 
like zippers, buttons, etc. We can provide clean linen for those that do not have form-fitting clothing 
attire. Patients will be asked to refrain from ingesting any dyes, calcium or barium supplements as this 
may affect DXA results. 
In-person Measurements:
Each procedure and the measurement tool are listed down in sequence. A summary of the in-person 
measurements is described in table 1.  The following body composition procedures will take place at 
the outpatient clinic (Clinical Trials Unit Core) at PBRC.
Table 1: In-person study measurements breakdown
Sequence
Procedure
Time
Total time
Arrive at PBRC 
Consenting Process
20m
20m
Outpatient Clinic
Vital signs; Fasting blood work, Urine testing (pregnancy 
test in women of childbearing age)
30m
50m
Baseline Measurements Body Weight/Height
10m
1h
Isotopes
Drink Deuterium then Bromide dilutions.
10m
1h10m
Questionnaires
Complete diet and physical activity questionnaires
20m
1h30m
Dual-Energy X-ray 
Absorptiometry (DXA)
Measure body composition
20m
1h50m
BodPod
Measure body volume
20m
2h10m
3D Optical imaging
Automatically measure body dimensions with several 
devices
30m
2h40m
Anthropometrics
Waist Circumferences with tape measure
20m
3h
Six-minute Walk
Measure distance to complete 6 minutes of walking
20m
3h 20m
Muscle Strength & 
Endurance measure
Measure leg strength and endurance
30m
3h 50m
Outpatient Clinic
Blood samples follow up (collected at 4h post- dose)
20m
4h10m
Bioimpedance Analysis 
(BIA)
Measure body composition with several devices
20m
4h30m
Abdomen, Pelvis and 
Thigh MRI
Measure skeletal muscle, visceral and subcutaneous 
fats
40m
5h10m
Complete Study Measurement
Study Timelines
The duration anticipated to enroll and complete data collection is 8 months after the IRB has been 
approved. These milestones will help ensure that this pilot study stays on track and achieves its 
objectives within the 1-year grant period.
 
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Study Timeline (1-year)
Study Quarterly 
Milestones
Q1
July-September 2025
a.
Complete the final study protocol 
b.
Submit the protocol & any other related documents for 
review to the Ethics Board/IRB.
c.
Receive Ethics Board/IRB protocol approval
d.
Participant recruitment
Q2
October-December 2025
a.
Training and calibration of assessment tools
b.   Participant recruitment
b.
Baseline data collection
c.
Clean data 
d.
Preliminary data analysis
Q3
January-March 2026
a.
Continued data collection 
b.
Follow up assessment
c.
Enter and clean data
d.
Data analysis
e.
Prepare manuscripts
Q4
April-June 2026
a.
Data analysis
b.
Prepare manuscripts and the final report 
c.
Present findings
 
Year 1
Activity
Q1
Q2
Q3
Q4
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
Screening and recruitment
 
 
 
 
 
 
 
 
 
 
 
 
Data Collection
Baseline and follow up data collection
 
 
 
 
 
 
 
 
 
Data Analysis
 
 
 
 
 
 
 
 
 
 
 
 
Draft and submit manuscripts
 
 
 
 
 
 
 
 
 
 
 
 
Study Endpoints
The primary endpoint of this pilot study is to evaluate the effectiveness of different body composition 
measurement tools (aim 1) before and 6 months after metabolic surgery (MS), and the secondary 
endpoints are to study the aim 2 and 3.
Aim 1: Evaluate the Effectiveness of Different Body Composition Measurement Tools
Rationale: Traditional methods like BMI and waist circumference may not accurately reflect changes 
in body composition, especially in patients with severe obesity. Advanced tools can provide more 
precise data.
Approach: 
Participants: Recruit patients with severe obesity (BMI ≥ 40) scheduled for MS.
 
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Body Composition Measurements: BMI, waist circumference, leg strength, skeletal muscle mass, fat 
mass, free fat mass, extracellular water (ECW) and total body water (TBW)
Measurement Tools: Use the Bioelectrical Impedance Analysis (BIA), 3-compartment (3C) model 
optical imaging, isotope dilution, densitometry (BOD POD), Dual energy X-ray Absorptiometry (DXA), 
and MRI scan
Data Collection: Measure body composition using traditional and advanced measurement tools at 
baseline (pre-surgery) and 6 months post-surgery.
Analysis: Compare the effectiveness of each tool in assessing body composition changes.
Expected Outcome: Advanced tools will provide more accurate and clinically relevant data compared 
to traditional methods. We will use DXA as the reference standard and compare other methods against 
it.
Aim 2: Assess Changes in Body Composition and Muscle Strength Following MS
Rationale: Understanding changes in body composition and muscle strength post-surgery can help 
improve patient outcomes and tailor post-operative care.
Approach:
Participants: Same cohort as Aim 1.
Measurements: Same cohort as Aim 1
Data Collection: Measure at baseline and 6 months post-surgery.
Analysis: Compare pre- and post-surgery data to evaluate changes in muscle strength and body 
composition.
Expected Outcome: Patients will experience a reduction in muscle strength, along with a more 
significant decrease in fat mass compared to muscle mass.
Aim 3: Compare Body Composition Changes Between SG and RYGB Patients
Rationale: Each metabolic surgery procedure may result in varying body composition outcomes. 
Comparing these can inform surgical decisions and patient counseling.
Approach:
Participants: Divide the cohort into two groups based on the type of surgery (SG or RYGB). Each group 
has 10 participants (5 male and 5 female)
Measurements: Use the same body composition tools as in Aim 1.
Data Collection: Measure at baseline and 6 months post-surgery.
Analysis: Compare body composition changes between the two groups.
Expected Outcome: RYGB patients will experience a greater reduction in subcutaneous, visceral, and 
total fat compared to SG patients after 6 months
 
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Procedures Involved
Details of the procedures for this pilot study are:
Urine Collection (5 minutes): All participants will provide a urine sample to test for urine specific 
gravity. In addition, a urine pregnancy test will be administered for female participants that are pre and 
perimenopausal. A negative pregnancy result is required prior to proceeding with the following 
measurements.
Manual Anthropometry (20 minutes): Weight and height will be measured twice. Circumferences of 
waist, hip, midarm and midthigh (left and right) will be measured three times and recorded.
Blood draws (15 minutes): Phlebotomist collect blood samples at baseline and again at 4 hours.
During the visit, a phlebotomist will complete two blood draws. The blood samples will be completed 
at the beginning of the visit. Blood samples (3ml) used for the sodium bromide and deuterium at 
baseline and 4hrs post-dose.
Deuterium Dilution (4 hours): Deuterium is a stable, non-radioactive isotope of Hydrogen. It is given 
orally as deuterium oxide and after mixing with body water, it is eliminated from the body in urine, 
saliva, sweat, etc. Deuterium oxide is handled in the body the same way as water, and it is dispersed 
through the body within a matter of hours. First, a baseline sample of blood (3 ml) will be collected. 
Participants will then be given water that’s mixed with the weight-appropriate deuterium dose. A blood 
sample will be collected at 4 hours. A maximum of 2 samples will be collected. If the participant is 
thirsty during the protocol, study staff will weigh the drink before the participant consumes it. If the 
participant needs to use the bathroom during the protocol, study staff will record the weight of the 
 
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participant prior to and following a void. The samples collected will have the participant ID number, 
date, and time of collection. All samples will be sent to PBRC for processing.
Sodium Bromide Dilution (4 hours): Extracellular water provides information on nutritional status in 
health and disease. The dilution of non-radioactive sodium bromide is widely used in clinical research 
to measure ECW (1-3). A blood sample of 3ml will be collected before ingesting an appropriate amount 
of sodium bromide based on body weight diluted in deionized water. A blood sample of 3ml will be 
collected 4 hours after ingestion. During the 4-hour period participants must refrain from eating 
anything, but they can drink water if needed. Study staff will weigh the drink before the participant 
consumes it. If the participant needs to use the bathroom during the protocol, study staff will record the 
weight of the participant prior to and following a void. The samples collected will have the participant 
ID number, date, and time of collection. All samples will be processed at PBRC.
Vital Signs (5 minutes): Blood pressure and pulse rate will be measured twice and recorded.
6-minute walk (20 minutes): Study Co-Ordinator will time the 6-minute walk of the participant.
Bioimpedance Analysis (BIA) (20 minutes): This is a measurement of conductance of extremely low 
frequency through water, fat, and muscle. This measurement allows us to measure the amount of 
water inside and outside of cells, as well as the muscle and fat in the body. BIA devices involve 
placement of electrode patches or metal touch-type electrodes on the skin, either on each hand and 
ankle or bottoms of the feet. One test takes about a few minutes to complete. Each participant will 
complete duplicate tests using several different BIA devices.
Dual Energy X-Ray Absorptiometry (DXA) (10 minutes): This scan measures the amount of bone, 
muscle, and fat, along with the mass of the head, arms, trunk, and legs. The scan will be performed 
using a Hologic DXA scanner. The participant will be required to remove all metal-containing objects 
from the body and to lie down on the table. The participant will be carefully positioned on the table. A 
scanner emitting low energy X-rays and a detector will pass along the body. One scan takes 
approximately 3 minutes. Each participant will complete one scan.
Densitometry/ Air Displacement Plethysmography (15 minutes): The BOD POD estimates the 
amount of fat mass and fat-free mass. Participants will be required to remove all metal-containing 
objects from the body. Participants will be required to wear form-fitting clothes and a swim cap during 
the procedure. We will provide a clean swim cap. Participants will sit inside the system like they are 
sitting on a chair. The door of the system will be closed, but there is a window so they can see outside 
while the measurements are completed. Each participant will complete one scan.
3D Optical Scanning (10 minutes): Body shape will be imaged and measured (circumferences and 
body volumes) using 3D optical scanners. Each participant will be scanned twice. Participants will be 
positioned standing on a flat surface while the cameras capture their body shape. The participants will 
need to stay as still as possible. The scan time takes about 1 minute to complete.
Muscle Strength & Endurance (30 minutes): Biodex Isokinetic Machine: Strength testing in the 
upper leg muscle will be completed. Participants will be seated in a chair attached to a computer. To 
isolate the tested muscles, feet, and hips will be secured with a strap like a seatbelt. The leg tested will 
be extended (straightened at the knee) against the machine. 
Questionnaires (20 minutes): Participants will complete a questionnaire about their physical activity 
(attached) and diet (https://asa24.nih.gov/).
Participants will also complete 3 brief questionnaires that assess eating behaviors8-11 (attached).
 
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Abdomen, Pelvis and Thigh MRI scan (40 minutes): This scan will estimate the amount of skeletal 
muscle and regional (visceral) fat in the body. Participants will be required to remove all metal-
containing objects from the body. Participants will be provided with earplugs and/or a headset to put 
over their ears for the duration of the scan. Participants will be given a call button if they need to notify 
the MRI tech during the scan. Participants will lie on their backs on the scanner table. The scan will 
start at the abdomen and proceed down to the thigh. The body will be scanned in sections. For the 
abdominal sections, participants will be asked to try their best to hold their breath a few times for 
approximately 15 seconds each time. Each participant will complete one scan.
Statistical Methods 
Many of the comparisons will be exploratory and will need to be confirmed by follow-up studies. 
Continuous variables will be descriptively summarized by sample size, mean, standard deviation (SD), 
and standard error of the mean (SE). Type-II errors, i.e., failing to detect a significant effect when they 
exist, is important to this study. All tests of significance for comparisons will be performed at an alpha 
of 0.05. To address the goals outlined in the Aim, parametric statistical modeling, including analysis of 
covariance, multiple regression method and correlation analysis, will be employed where feasible. 
Paired testing will be used as well given the repeated measures design. 
Data and Specimen Management
Each participant will have a hard-copy study file kept in a locked cabinet under control of the study 
coordinator in the participant’s chart located in the Medical Records Department (PBRC). Digital data 
will include the electronic data exported from each system. All results will be kept in locked cabinet 
files and/or restricted-access computers. All of those will be kept separate from records with names 
and other personal information. No information about them, or provided by them during the research, 
will be disclosed to others without their written permission, except if it is necessary to protect their 
rights or welfare (for example, in case of injury or emergency care), or if it is required by law. When the 
results of the research are published or discussed at conferences, no information will be included that 
would reveal the identity of these subjects. All data will be kept in locked files, and subjects will be 
identified by codes when the data gathered in this procedure is presented or published.  
Provisions to Protect the Privacy Interests of Participants
Screening, data collection, and other interactions including physical locations, telephone contact, mail 
or email solicitations will be performed to afford protection against interactions with participants being 
witnessed, overheard or inadvertently intercepted or viewed. A private setting with door closed will be 
used to conduct physical measurements, record and discuss private medical information. We will ask 
beforehand if it would be convenient to answer sensitive questions by telephone while at home or work.
The information being collected will only be the minimum amount of data necessary to accomplish the 
research purposes. Upon enrollment participants will be given a study ID. Data collected will be 
identified by the given study ID. The code linking the study ID to the participants’ name will remain on 
encrypted, password protected document. That document will be accessed by limited study personnel 
(PI, Program Manager, Study MD, and Study Coordinator).
If information from this study is published or presented at scientific meetings, all names and other 
personal identifying information will not be used. PBRC may look at and/or copy the coded data for 
research, quality assurance, and data analysis for 5 years (2026-2030).
 
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Data Security
Data will be protected so that it is HIPAA compliant as follows:
-
The de-identified data will only be on a network-shared drive or password protected computers 
stationed within a locked room.
-
All staff members at PBRC with access to the data will have up-to-date HIPAA training.
-
Any users connecting to the data will use a secure Pennington Center network share.
Provisions to Monitor the Data to Ensure the Safety of Subjects
While SAEs are not expected, any adverse events experienced by participants while participating in 
the protocol will be reported to the medical investigator and appropriate actions will be taken. A log of 
adverse events will be kept by the study coordinator and reviewed periodically with the study 
investigators. The investigators will determine safety triggers for bone density and body composition 
measures that may warrant further review by the MD on the study. Any outliers will be included in a 
quarterly quality control report that will be reviewed by study investigators. Any measures that fall 
below the safety thresholds will be reported to the participants and they will be given counseling by the 
investigators on what if any action should be taken.
Personnel Responsible for the Safety Review and Frequency 
The Safety Officer will be responsible for monitoring the data, assuring protocol compliance and 
conducting the safety reviews at the specified frequency, at a minimum of every 6 months (including 
at the time of continuing review). During the review process, the Safety Officer will evaluate whether 
the study should continue unchanged, require modification/amendment or should close to enrollment. 
Findings must be reported at the time of continuing review. The IRB, PI or regulatory body has the 
authority to stop or suspend the study or require modifications.
Although the proposed study is more than minimal risk, the potential exists for anticipated and/or 
unanticipated adverse events, serious or otherwise, to occur since it is not possible to predict with 
certainty the absolute risk in any given individual or in advance of firsthand experience with the 
proposed study methods. Therefore, we provide a plan for monitoring the data and safety of the 
proposed study as follows: 
Adverse Event Grading
Adverse events for each subject participating in the study will be monitored and attributed to the 
study procedures/design by the Safety Officer according to the following categories: 
•
Definite: Adverse event is clearly related to investigational procedure(s)/agent(s).
•
Probable: Adverse event is likely related to investigational procedure(s)/agent(s).
•
Possible: Adverse event may be related to investigational procedure(s)/agent(s).
•
Unlikely: Adverse event is likely not related to the investigational procedure(s)/agent(s).
•
Unrelated: Adverse event is clearly not related to investigational procedure(s)/agent(s).
 
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Plan for Grading Adverse Events
The following scale will be used in grading the severity of adverse events noted during the study: 
•
Mild adverse event
•
Moderate adverse event
•
Severe or medically significant
Plan for Determining Seriousness of Adverse Events
In addition to grading the adverse event, the Medical Investigator will determine whether the adverse 
event meets the criteria for a Serious Adverse Event (SAE). An adverse event is considered serious 
if ANY of the following apply: 
•
It is life-threatening.
•
It results in inpatient hospitalization or prolongation of existing hospitalization.
•
It results in persistent or significant disability or incapacity. 
•
It results in a congenital anomaly or birth defect. 
•
It results in death. 
•
Based upon appropriate medical judgment, it may jeopardize the subject’s health 
and may require medical or surgical intervention to prevent one of the other 
outcomes listed in this definition.
•
It adversely affects the risk/benefit ratio of the study. 
An adverse event may be graded as severe but still does not meet the criteria for a SAE. Similarly, 
an adverse event may be graded as moderate but still meets the criteria for an SAE. It is important 
for the PI to consider the grade of the event as well as its seriousness when determining whether 
reporting to the IRB is necessary. 
Plan for Reporting Adverse Events
The investigator will report the following types of adverse events to the IRB: 
•
Serious AND unanticipated AND possibly, probably or definitely related events.
•
Anticipated adverse events occurring with a greater frequency than expected.
•
Other unanticipated problems involving risks to subjects or others. 
These adverse events or unanticipated problems involving risks to subjects or others will be reported 
to the IRB within 10 working days of becoming known to the investigator, using the appropriate forms 
found in IRB Manager.
Withdrawal of Subjects
Participation in this study is voluntary. Participants can withdraw at any time, including during the two 
study visits, without any penalty or loss of entitled benefits. Data already collected, along with 
information from medical records, may still be used, but no new data will be collected.
 
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Although participants are not obliged to give their reason(s) for withdrawing from a trial, a reasonable 
effort will be made to ascertain the reason(s) while fully respecting the participants’ rights. 
Sharing Results with Subjects
Participants will receive body composition reports which will include their bone density, fat mass, and 
lean mass estimates, leaving them informed of new and useful health information.
Risks to Subjects
The BCOMS study risk cannot be classified as minimal. Continuous monitoring by the PI will 
minimize all potential risks and discomforts.  Research participants will be immediately 
withdrawn from the study upon evidence of any significant adverse event. 
Potential risks with the study procedures involved are listed in the table below
 
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Procedure:
Potential Risk(s):
Blood collection/IV 
placement
Bruising, bleeding, pain, Infection.  These will be minimized by our trained 
phlebotomists using aseptic technique.
Manual Anthropometry
There is no known risk associated with manual anthropometry 
measurements.
Deuterium Dilution
There is no known risk associated with this measurement when digesting 
in small doses. Deuterium is a stable non- radioactive isotope that has 
been previously administered to humans in numerous clinical research 
studies.
Physical activity and 
diet Questionnaires
No risks for questionnaires. If participant is uncomfortable answering or 
does not want to answer a question, it can be skipped.
Six-minute Walk test
This test is performed by having the participant walk along a straight 
hallway for six minutes and measuring the distance walked and the 
sensations of leg fatigue and dyspnea.  The test is largely self-directed and 
self-limited. Participants are closely monitored by study staff throughout 
the test duration. As with any exercise test, there is a theoretical risk that 
a participant could suffer cardiac risk from arrhythmia or sudden arrest.  
However, we have performed thousands of tests without adverse events.
Bromide Dilution
There is no known risk associated with this measurement when digesting 
in small doses. Sodium Bromide Dilution has been previously administered 
to humans in numerous clinical research studies.
Bioimpedance Analysis 
(BIA) 
There is no known risk associated with the BIA measurement. The BIA 
uses a very small electric current, which passes between electrodes 
placed on the hand and foot. This amount of current is slight enough that 
it cannot be felt and poses no risks to humans. However, there is a slight 
risk that this low current could disrupt an artificial pacemaker or 
defibrillator.
Participants will be screened at the time of enrollment and will be excluded 
if such a device is present.
Dual Energy X-Ray 
Absorptiometry (DXA)
We will perform Whole body scan. This scan measures the amount of 
bone, muscle, and fat in the body.  The scan will be performed using a 
whole-body scanner.  Participant will be required to wear a hospital gown, 
to remove all metal-containing objects from the body, and to lie down on 
the table.  A scanner emitting low energy X-rays and a detector will pass 
along the body. Participant is asked to remain completely still while the 
scan is in progress. This scan is for research purposes only and not for 
diagnostic treatment.
 
Risks: The amount of radiation used for this procedure is very small.  The 
radiation dose for a DXA scan is equivalent to the radiation you are 
naturally exposed to in the environment in less than one day. 
Scans will not be performed on any subject who is pregnant.  
Urine pregnancy testing will confirm pre/perimenopausal women are not 
pregnant prior to DXA evaluation. 
 
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Lifetime radiation exposure: We are exposed to radiation in the 
environment on a daily basis; however, some scientists have suggested 
that humans have a lifetime maximum exposure limit.  Exposure to 
radiation is not without risk, but it is difficult to quantify the exact amount 
someone is exposed to.  By participating in this study, participants will be 
exposed to radiation that will add to this lifetime maximum exposure 
limit.  If participants is exposed to a significant amount of radiation as part 
of occupation or due to treatment for a specific medical condition, 
participants should notify the study team to discuss whether or not this 
study would be appropriate for them. 
Air Displacement 
Plethysmography 
(BodPod)
There is no known risk associated with the BodPod measurement. There 
is a large window so participants can easily view outside of the BodPod 
during the measurement; however, this measurement may be 
uncomfortable if you are claustrophobic.
3D Optical Imaging 
(3DO)
There is no known risk associated with the 3DO measurement. The 3DO 
scans are not a standard procedure for patients; however, the scanning 
process does not involve using the imaging cameras in any unusual way.
Abdomen, Pelvis and 
Thigh MRI
We will perform abdominal MRI together with a single-slice thigh 
acquisition for the study participant.
There are no known biological risks associated with magnetic resonance 
scanning.  It has been used routinely for over 20 years.  It produces side 
effects in very few situations.  Those situations include:
 
Metal: Because the magnetic resonance machine uses a magnetic field, it 
can move any metallic objects that are inside the body. This disruption of 
metal inside the body is extremely dangerous and may even be life 
threatening. If you think you may have a cardiac stent, metallic implant, 
metallic piercings, shrapnel, or any other metallic material in your body, it 
is of utmost importance that you alert the study coordinator or MR 
technician. If you have metallic materials in the body that cannot be 
removed, the MR Technician, in consultation with the Medical Investigator 
of the study, will evaluate the safety of MRI scanning in the presence of 
those metallic materials and may exclude you from MRI for that reason.
 
Electronics: Magnetic resonance imaging involves the use of radio 
frequency energy that can disrupt the functioning of electronic devices.  If 
you think you might possess a pacemaker or any other electronic medical 
device inside your body, it is of utmost importance that you inform the study 
coordinator or MR technician.  If you have any such electronic devices we 
will exclude you from this study for your safety.
Tattoos and cosmetics: Some tattoos and cosmetics contain metallic 
materials that can heat up during scanning, especially if they are located 
on the part of the body being scanned.  If the metallic material heats up 
enough, you may feel an uncomfortable burning sensation, and a skin burn 
may develop.  If you have any tattoos or cosmetics that might contain 
metallic materials, please alert the study coordinator or MR technician.  If 
you feel a burning sensation on your skin, alert the study coordinator or 
MR technician.  In some cases, the amount of metallic material in the area 
being scanned is so excessive that the scan must be stopped.  In other 
 
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cases, a cold compress placed over the metallic material will be used to 
prevent the burning sensation.
Confinement: During the MR scan, you will be lying down on a table inside 
of a metal tube.  The metal tube is a confined place.  This might produce a 
feeling of claustrophobia, which can be distressing.  If you have 
experienced claustrophobia in the past, you might become too distressed 
to complete the scan.  If you become distressed during the scan due to 
confinement in the scanner tube, please alert the MR technician and the 
scan will be halted.
Noise: The MRI machine creates a loud, rhythmic noise that sounds like 
grinding or churning.  This can be distressing to those who are sensitive to 
loud noises.  You will be provided with earplugs to reduce the noise.  But 
if you find the machine noises distressing, alert the MR technician and the 
scan can be halted.
Peripheral nerve stimulation: During the MRI scan, the magnetic field 
around the body goes through rapid changes. These changes are all within 
safety limits set by the Food and Drug Administration. But some people 
experience twitching in the nerves of their arms or legs as a result of these 
magnetic field changes. This twitching is generally not painful, and it stops 
at the end of the MRI scan. But the feeling of inadvertent muscle twitching 
may make individuals feel disoriented or uncomfortable. Any participant 
who experiences this and wishes to stop the scan as a result will be 
allowed to do so. 
Venous thromboembolism: In some elderly or obese individuals, 
prolonged immobilization may be associated with an increased risk of 
venous thromboembolism. The MRI technologist reduces this risk in two 
ways. First, every effort is made to keep scan times for elderly and obese 
individuals as short as possible, usually 1 hour or less. Second, during 
breaks in the MRI acquisition, the MRI technologist encourages the 
participant to move all extremities and reposition the body. Such breaks 
occur in between acquired MRI sequences—roughly every 10 to 20 
minutes.
Physical frailty: The MRI technologist performing the scan has received 
extensive training in how to position all participants, including elderly ones, 
in the MRI machine safely and comfortably.  However, some older people 
have a more difficult time walking or moving their bodies due to arthritis 
and other conditions. There is a slight chance that these individuals could 
feel discomfort or fall during transitions into or out of the MRI scanner.  The 
technologist will insure that the walkway to the scanner is safe for 
participant to walk on, will place cushioning on the scanner table for 
participant comfort, and will carefully guide movements around the scanner 
to minimize this risk.
Other Related Risks:
 
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Metabolic Surgery: MS carries a risk for complications and nutritional deficiencies. Both Roux-
en-Y gastric bypass and sleeve gastrectomy surgeries have similar risks. Abdominal hernias 
are the most common complications requiring follow-up surgery. Rare complications include 
leakage through staples or sutures, ulcers in the stomach or small intestine, blood clots in the 
lungs or legs, stretching of the pouch or esophagus, persistent vomiting and abdominal pain, 
inflammation of the gallbladder, and failure to lose weight (very rare).
Psychological: The patients may have anxiety related to the course of their disease and/or the 
requirement for invasive surgery and medication side effects. 
Risk Classification: The study risk cannot be classified as minimal.
Minimizing Risks: 
Continuous monitoring by the PIs will minimize all potential risks and discomforts.  Research 
participants will be immediately withdrawn from the study upon evidence of any significant adverse 
event.
Potential Benefits: 
There is no direct benefit to the participants, but knowledge may be gained that will benefit others.  
Participants will receive body composition reports which will include their bone density, fat mass, and 
lean mass estimates, leaving them informed of new and useful health information.
Payment for Participation: 
Participants will receive $100 for each complete study visit, totaling $200 for both visits. If a participant 
does not complete both visits, they will only be compensated for the visits they have completed. There 
is no compensation for the time spent on screening.
Financial Obligations of the Subjects: 
Pennington Biomedical Research Center and the study Sponsor are not responsible for these costs.
Emergency Care and Compensation for Research-Related Injury:
No form of compensation for medical treatment is available from the Pennington Biomedical Research 
Center. In the event of injury or medical illness resulting from the research procedures participants will 
be referred to a treatment facility. Medical treatment may be provided at their expense or at the expense 
of their health care insurer (e.g., Medicare, Medicaid, Blue Cross-Blue Shield, Dental Insurer, etc.) 
which may or may not provide coverage.
Vulnerable Populations
This research does not involve individuals who are vulnerable to coercion or undue influence. We will 
seek consent only under circumstances that provide the prospective participant with an adequate 
opportunity to consider whether or not to participate. Once enrolled, a participant can voluntarily 
withdraw at any time point during the study.
 
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Setting and Resource Available
Selection of study site: The study will be conducted at the 
Metamor Institute and PBRC which has a proven record of recruiting 
and treating patients with severe obesity. In 2023, the Metamor 
Institute had 1215 bariatric surgery outpatient clinic visits and 
performed 420 surgeries.  
Experience in metabolic surgery in patients with severe 
obesity. 
Dr. Schauer is a pioneer of metabolic surgery (MS), has.
refined the techniques and approaches for patients with 
severe obesity. 
In 2023, the total number of sleeve gastrectomy and 
gastric bypass procedures performed at Metamor were 
201 and 117 cases, respectively. Majority (70%) of these 
patients have severe obesity (BMI ≥ 40) and more than 
70% were female.
This pilot study leverages the expertise at the Metamor 
Institute, the Metabolism and Body Composition 
Laboratory and the Biomedical Imaging Center, at 
PBRC. By integrating knowledge from metabolic 
surgery, metabolism, advanced imaging, we aim to 
develop an innovative approach to assessing body composition outcomes in metabolic surgery patients. 
This collaboration will enhance the robustness and applicability of our findings.
With state-of-the-art facilities and robust institutional support, PBRC provides the ideal environment to 
achieve our research goals. Our well-structured and highly skilled team collaboration is uniquely 
equipped to conduct this pilot research and deliver meaningful outcomes.
Prior Approvals
There is no prior approval.
Data Collection, Storage and Confidentiality
All results will be kept in locked cabinet files and/or restricted-access computers. All of those will be 
kept separate from records with names and other personal information. No information about them, or 
provided by them during the research, will be disclosed to others without their written permission, except 
if it is necessary to protect their rights or welfare (for example, in case of injury or emergency care), or 
if it is required by law. When the results of the research are published or discussed in conferences, no 
information will be included that would reveal the identity of these subjects. All data will be kept in locked 
files, and subjects will be identified by codes when the data gathered in this procedure is presented or 
published.  
PRIVACY & CONFIDENTIALITY
Where and how data or specimens will be stored locally? Data will be stored on Pennington servers as 
part of the computer cloud computing system.
 
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How long will the data or specimens be stored locally? Identifiable data will be stored for 5-years 
following the completion of the study. Deidentified versions of the data will be stored indefinitely.
Who will have access to the data or specimens locally? Only the research personnel and PI will have 
access to study data. Password protected imaging and laboratory data will be kept locally at 
Pennington.
Who is responsible for receipt or transmission of the data or specimens locally? All data specimens will 
be kept locally at Pennington Biomedical.
What information will be included in that data or associated with the specimens? All specimens will be 
assigned a de-identified study number and stored with that number for location purposes.
Where and how data or specimens will be stored? De-identified data will be stored indefinitely on 
password-protected computers. Only the PI and co-investigators will have access to the full data during 
the study.
How long will the data or specimens be stored? Electronic, de-identified data will be stored indefinitely 
on password protected computers. De-identified biological samples will be stored indefinitely.
Provisions to Protect the Privacy Interests of Subjects
Describe the steps that will be taken to protect subjects’ privacy interests. Usual care and conduct of 
research studies at Pennington Biomedical involves a large team of many different individuals and 
providers. However, participants choosing to participate in this study will have contact with the research 
staff as necessary to participate in the study. Most of the staff will not have access to their full PHI but 
will only have the relevant information on their testing or necessary information for safety purposes. 
Only the PI will have access to all protected health information as well as data gathered for research 
purposes. Other provisions to protect privacy will include health history or exam result discussions in a 
private area and asking any accompanying family members/acquaintances to temporarily leave the 
room.
Economic Burden to Subjects
There are no costs that participant may be responsible for because of participation in the research.
Consent Process
Prior to undergoing any study procedures, participants will be consented in a private room. These 
interactions will be kept confidential, and records maintained in a secure, designated location at each 
facility. A trained member of the study team (investigators, study research coordinator) will review the 
protocol. Interested participants will be given time to ask any questions about the study procedures. 
Informed written consent will be obtained from the participant. They will be informed that there will be 
no consequences if they decide not to enroll in the study and, if they enroll, they may withdraw from the 
study at any point with penalty.
 
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References:
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Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, De Luca M, Faria SL, 
Goodpaster KP, Haddad A, Himpens JM. 2022 American Society of Metabolic and Bariatric Surgery 
(ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) 
indications for metabolic and bariatric surgery.
2.
Courcoulas AP, Daigle CR, Arterburn DE. Long term outcomes of metabolic/bariatric surgery in 
adults. BMJ. 2023 Dec 18;383.
3.
Pareek M, Schauer PR, Kaplan LM, Leiter LA, Rubino F, Bhatt DL. Metabolic surgery: weight loss, 
diabetes, and beyond. Journal of the American College of Cardiology. 2018 Feb 13;71(6):670-87.
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Hanipah ZN, Schauer PR. Bariatric surgery as a long-term treatment for type 2 diabetes/metabolic 
syndrome. Annual review of medicine. 2020 Jan 27;71(1):1-5.
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Emmerich SD, Fryar CD, Stierman B, Ogden CL. Obesity and Severe Obesity Prevalence in Adults: 
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Zhao L, Park S, Ward ZJ, Cradock AL, Gortmaker SL, Blanck HM. Peer Reviewed: State-Specific 
Prevalence of Severe Obesity Among Adults in the US Using Bias Correction of Self-Reported Body 
Mass Index. Preventing Chronic Disease. 2023;20.
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Das SK, Roberts SB, Kehayias JJ, Wang J, Hsu LG, Shikora SA, Saltzman E, McCrory MA. Body 
composition assessment in extreme obesity and after massive weight loss induced by gastric bypass 
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Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales 
in assessment of appetite sensations in single test meal studies. International Journal of Obesity. 
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Meule A, Hermann T, Kübler A. A short version of the Food Cravings Questionnaire—Trait: the FCQ-
T-reduced. Frontiers in Psychology. 2014;5:190.
10. Diktas HE, Cardel MI, Foster GD, LeBlanc MM, Dickinson SL, Ables EM, Martin CK. Development 
and validation of the Food Noise Questionnaire. Obesity. 2025;33(2):289-297
11. Dhurandhar EJ, Maki KC, Dhurandhar NV, Kyle TK, Yurkow S, Hawkins MAW, Agley J, Ho EH, 
Cheskin LJ, Sørensen TIA, Wang XR, Gorman B, Allison DB. Development and rigorous multistep 
validation of a psychometric tool to measure food noise. Appetite. 2026;217:108339.
 
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Pennington Biomedical IRB FWA 00006218
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