ObesityBCOMSNCT07530718
Body Composition Outcomes in MS Patients
An observational study of Obesity, run by Pennington Biomedical Research Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Apr 2026to 31 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bariatric surgery patients with BMI 40 or more
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Pennington Biomedical Resarch Center
Baton Rouge, Louisiana, 70808
Zubaidah Nor Hanipah, MD, 225-763-2831, zubaidah.norhanipah@pbrc.edu
steven.heymsfield@pbrc.edu
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Zubaidah Nor Hanipah, MD, 2257632831, Zubaidah.Norhanipah@pbrc.edu
About this study
Official title: Outcome of Body Composition Assessment in Patients With Severe Obesity Undergoing Metabolic Surgery
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, the investigators 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.
Aim 2: Assess the changes in body composition and muscle strength following MS.
Aim 3: Compare body compositions changes between SG and RYGB patients.
Read the detailed description
Background Metabolic surgery (MS) is the most effective long term obesity treatment in patients with severe obesity. The prevalence of obesity among US adults is 40.3% and the prevalence of severe obesity is 9.4% (2021-2023). Despite the prevalence and severity of obesity, there is a significant knowledge gap regarding the most effective tools for assessing body composition in this population. Traditional methods such as BMI and waist circumference may not accurately reflect changes in body composition, particularly 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., 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.
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, the investigators 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. The investigators 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. The investigators hypothesize that 6 months post MS, patients will experience a change 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. The investigators hypothesize that RYGB patients will experience greater changes in subcutaneous, visceral, and total fat compared to SG patients after 6 months.
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, skeletal muscle, adipose tissue, weight loss
- Medical subject headings
- Obesity, Weight Loss
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 |
|---|---|---|
| Cohort 1 | Roux-en-Y gastric bypass surgery | |
| Cohort 2 | Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).
Measurement of weight in kilograms
Measured: Baseline and 6 months
Evaluate the effectiveness of Leg Strength and Endurance Testing in assessing outcomes in patients with severe obesity undergoing MS.
Leg muscle strength measured in in Newton-meters (Nm)
Measured: Baseline and 6 months
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS
height in meters
Measured: Baseline and 6 months
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS
weight and height will be combined to report BMI in kg/m^2
Measured: Baseline and 6 months
Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS
Measure skeletal muscle mass volume in cm^3
Measured: Baseline and 6 months
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS
body fat percentage in %
Measured: Baseline and 6 months
Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS
Measure waist circumference in cm
Measured: Baseline and 6 months
Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS
Mid-thigh circumference in cm
Measured: Baseline and 6 months
Evaluate the effectiveness of BIA measurement tool in assessing outcomes in patients with severe obesity undergoing MS
weight and height will be combined to report BMI in kg/m^2
Measured: Baseline and 6 months
Evaluate the effectiveness of anthropometric measurement tools in assessing outcomes in patients with severe obesity undergoing MS
Hip circumference in cm
Measured: Baseline and 6 months
Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS
Measure visceral adipose tissue volume in cm^3
Measured: Baseline and 6 months
Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS
Measure subcutaneous adipose tissue volume in cm^3
Measured: Baseline and 6 months
Evaluate the effectiveness of Six-Minute Walk testing in assessing outcomes in patients with severe obesity undergoing MS.
Physical endurance will be measured by the distance walked during a 6-minute walk test in meter
Measured: Baseline and 6 months
Evaluate the effectiveness of 3D Optical Imaging in assessing outcomes in patients with severe obesity undergoing MS.
Measure body volume in cm^3
Measured: Baseline and 6 months
Evaluate the effectiveness of BodPod (Air Displacement Plethysmography) in assessing outcomes in patients with severe obesity undergoing MS
Measure body volume in liters
Measured: Baseline and 6 months
Evaluate the effectiveness of BodPod in assessing outcomes in patients with severe obesity undergoing MS.
Measure body density in kilograms per cubic meter (kg/m^3)
Measured: Baseline and 6 months
Evaluate the effectiveness of Dual Energy X ray Absorptiometry (DXA) in assessing outcomes in patients with severe obesity undergoing MS
Measure total fat mass in kg
Measured: Baseline and 6 months
Evaluate the effectiveness of DXA in assessing outcomes in patients with severe obesity undergoing MS
Measure lean mass /fat free mass in kg
Measured: Baseline and 6 months
Evaluate the effectiveness of Deuterium & Bromide Dilution in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).
Measure total body water in liter
Measured: Baseline and 6 months
Evaluate the effectiveness of Deuterium & Bromide Dilution in assessing outcomes in patients with severe obesity undergoing MS.
Measure extracellular water in liters
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start14 Apr 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Our Lady of the Lake Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530718
- Sponsor's protocol ID
- 2025-012
- Acronym
- BCOMS
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. 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. 4. 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. 5. Emmerich SD, Fryar CD, Stierman B, Ogden CL. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021-August 2023. 6. 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. 7. 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 surgery. American Journal of Physiology-Endocrinology and Metabolism. 2003 Jun 1;284(6):E1080-8. 8. 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. 2000;24(1):38-48. 9. 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. 2
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Body Composition Assessment in Patients With Severe Obesity Undergoing Metabolic Surgery
- ClinicalTrials.gov ID
- NCT07530718
- Acronym / sponsor ID
- BCOMS / 2025-012
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, skeletal muscle, adipose tissue, weight loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Our Lady of the Lake Hospital
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
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, the investigators 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.
Aim 2: Assess the changes in body composition and muscle strength following MS.
Aim 3: Compare body compositions changes between SG and RYGB patients.
Detailed description
Background Metabolic surgery (MS) is the most effective long term obesity treatment in patients with severe obesity. The prevalence of obesity among US adults is 40.3% and the prevalence of severe obesity is 9.4% (2021-2023). Despite the prevalence and severity of obesity, there is a significant knowledge gap regarding the most effective tools for assessing body composition in this population. Traditional methods such as BMI and waist circumference may not accurately reflect changes in body composition, particularly 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., 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.
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, the investigators 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. The investigators 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. The investigators hypothesize that 6 months post MS, patients will experience a change 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. The investigators hypothesize that RYGB patients will experience greater changes in subcutaneous, visceral, and total fat compared to SG patients after 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Roux-en-Y gastric bypass surgery |
| Cohort 2 | – | –Sleeve Gastrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bariatric surgery patients with BMI 40 or more
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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
Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).
Time frame: Baseline and 6 months
Measurement of weight in kilograms
Evaluate the effectiveness of Leg Strength and Endurance Testing in assessing outcomes in patients with severe obesity undergoing MS.
Time frame: Baseline and 6 months
Leg muscle strength measured in in Newton-meters (Nm)
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
height in meters
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
weight and height will be combined to report BMI in kg/m^2
Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
Measure skeletal muscle mass volume in cm^3
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
body fat percentage in %
Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
Measure waist circumference in cm
Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
Mid-thigh circumference in cm
Evaluate the effectiveness of BIA measurement tool in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
weight and height will be combined to report BMI in kg/m^2
Evaluate the effectiveness of anthropometric measurement tools in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
Hip circumference in cm
Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
Measure visceral adipose tissue volume in cm^3
Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
Measure subcutaneous adipose tissue volume in cm^3
Evaluate the effectiveness of Six-Minute Walk testing in assessing outcomes in patients with severe obesity undergoing MS.
Time frame: Baseline and 6 months
Physical endurance will be measured by the distance walked during a 6-minute walk test in meter
Evaluate the effectiveness of 3D Optical Imaging in assessing outcomes in patients with severe obesity undergoing MS.
Time frame: Baseline and 6 months
Measure body volume in cm^3
Evaluate the effectiveness of BodPod (Air Displacement Plethysmography) in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
Measure body volume in liters
Evaluate the effectiveness of BodPod in assessing outcomes in patients with severe obesity undergoing MS.
Time frame: Baseline and 6 months
Measure body density in kilograms per cubic meter (kg/m^3)
Evaluate the effectiveness of Dual Energy X ray Absorptiometry (DXA) in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
Measure total fat mass in kg
Evaluate the effectiveness of DXA in assessing outcomes in patients with severe obesity undergoing MS
Time frame: Baseline and 6 months
Measure lean mass /fat free mass in kg
Evaluate the effectiveness of Deuterium & Bromide Dilution in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).
Time frame: Baseline and 6 months
Measure total body water in liter
Evaluate the effectiveness of Deuterium & Bromide Dilution in assessing outcomes in patients with severe obesity undergoing MS.
Time frame: Baseline and 6 months
Measure extracellular water in liters
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 17 Jun 2026.
- Results publication1. 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. 4. 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. 5. Emmerich SD, Fryar CD, Stierman B, Ogden CL. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021-August 2023. 6. 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. 7. 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 surgery. American Journal of Physiology-Endocrinology and Metabolism. 2003 Jun 1;284(6):E1080-8. 8. 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. 2000;24(1):38-48. 9. 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. 2
- Individual participant dataSharing planned: No
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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.
2 sites 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 Pennington Biomedical Research Center at 2 sites 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Zubaidah Nor Hanipah, MD (225-763-2831, zubaidah.norhanipah@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS). (time frame: Baseline and 6 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07530718, which also lists 1 linked publication.
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 17 Jun 2026.