Body Composition Outcomes in MS Patients
Recruiting · NCT07530718 · Observational (researchers observe without assigning treatment) · Lead sponsor: Pennington Biomedical Research Center
View the official record on ClinicalTrials.gov →What this trial 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. 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 take part
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 it is running
2 locations listed across 1 US state.
- Pennington Biomedical Resarch Center - Baton Rouge, Louisiana, United States
- Pennington Biomedical Research Center - Baton Rouge, Louisiana, United States