Body Composition Outcomes in MS Patients (BCOMS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Zubaidah Nor Hanipah, MD; Phone Number: 225-763-2831; Email: zubaidah.norhanipah@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Resarch Center
      • Contact: Zubaidah Nor Hanipah, MD; Phone Number: 225-763-2831; Email: zubaidah.norhanipah@pbrc.edu
      • Contact: Email: steven.heymsfield@pbrc.edu
      • Sub-Investigator: Philip Schauer, MD
      • Sub-Investigator: Steven Heymsfield, MD
      • Sub-Investigator: Owen Carmichael, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Bariatric surgery patients with BMI 40 or more

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1; Roux-en-Y gastric bypass surgery
Cohort 2; Sleeve Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).	Measurement of weight in kilograms	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)	Baseline and 6 months
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS	height in meters	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	Baseline and 6 months
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS	body fat percentage in %	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Our Lady of the Lake Hospital

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Bariatric surgery; weight loss; skeletal muscle; adipose tissue
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss
• Other Study ID Numbers: 2025-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No