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NCT Number: NCT07530718

Body Composition Outcomes in MS Patients

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Resarch Center, Baton Rouge, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

  3. Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS

    Time frame: Baseline and 6 months

    height in meters

  4. 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

  5. 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

  6. 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 %

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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)

  17. 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

  18. 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

  19. 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

  20. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Zubaidah Nor Hanipah, MD

CONTACT

[email protected]

225-763-2831

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Our Lady of the Lake Hospital

Registry information

Official study title

Outcome of Body Composition Assessment in Patients With Severe Obesity Undergoing Metabolic Surgery

Acronym: BCOMS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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