Observational Study on Body Composition After Metabolic Surgery

This observational study aims to understand how different body composition tools, like Bioimpedance Analysis (BIA), measure changes in people with severe obesity after metabolic surgery (weight-loss surgery). Researchers want to see if these advanced tools provide more accurate information than traditional methods. They will also look at how body composition and muscle strength change after surgery, and compare these changes between two types of metabolic surgery: Sleeve Gastrectomy and Roux-en-Y Gastric bypass. You might be able to join if you are an adult (18 or older), have a BMI (Body Mass Index) of 40 or higher, weigh less than 440 pounds, and are scheduled for your first metabolic surgery. The study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 20 participants. It is not a randomized trial, meaning participants are not assigned to different treatment groups.
What's involved
You would have your body composition and leg strength measured at the beginning of the study and again six months after your metabolic surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for six months after their metabolic surgery.

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NCT07530718

Body Composition Outcomes in MS Patients

Recruiting
Not specifiedAges 18+Observational
Pennington Biomedical Research Center
~20 participants
Updated 2026-06-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).
Measured over Baseline and 6 months
+19 more outcomes measured
Obesity
2 sites across 1 states
Louisiana2

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Eligibility criteria

Inclusion

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

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.
  • Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).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.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 MSBaseline and 6 months

    height in meters

  • Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MSBaseline 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 MSBaseline 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 MSBaseline and 6 months

    body fat percentage in %

  • Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MSBaseline and 6 months

    Measure waist circumference in cm

  • Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MSBaseline and 6 months

    Mid-thigh circumference in cm

  • Evaluate the effectiveness of BIA measurement tool in assessing outcomes in patients with severe obesity undergoing MSBaseline 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 MSBaseline 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 MSBaseline 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 MSBaseline 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.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.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 MSBaseline and 6 months

    Measure body volume in liters

  • Evaluate the effectiveness of BodPod in assessing outcomes in patients with severe obesity undergoing MS.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 MSBaseline and 6 months

    Measure total fat mass in kg

  • Evaluate the effectiveness of DXA in assessing outcomes in patients with severe obesity undergoing MSBaseline 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).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.Baseline and 6 months

    Measure extracellular water in liters