Clinical trial

Body Composition Outcomes in MS Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT07530718

Recruiting nowNot applicableObservational

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. 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

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.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

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

Study locations

2 locations were listed when this page was built. The first 40 are shown.

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

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Zubaidah Nor Hanipah, MDContact

Email · Call 225-763-2831

Study contactContact

Philip Schauer, MDSub Investigator

Pennington Biomedical Research Center🇺🇸 Baton Rouge, Louisiana, United States

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Zubaidah Nor Hanipah, MDContact

Email · Call 2257632831