NCT07530718 · Pennington Biomedical Research Center
Body Composition Outcomes in MS Patients
(BCOMS)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Baton Rouge, Louisiana
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations