Recruiting NCT07530718

Body Composition Outcomes in MS Patients

— Observational Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Obesity. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

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.

Primary outcome measures

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]
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]
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS [Time frame: Baseline and 6 months]
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS [Time frame: Baseline and 6 months]
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]
Evaluate the effectiveness of BIA in assessing outcomes in patients with severe obesity undergoing MS [Time frame: Baseline and 6 months]
Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS [Time frame: Baseline and 6 months]
Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS [Time frame: Baseline and 6 months]
Evaluate the effectiveness of BIA measurement tool in assessing outcomes in patients with severe obesity undergoing MS [Time frame: Baseline and 6 months]
Evaluate the effectiveness of anthropometric measurement tools in assessing outcomes in patients with severe obesity undergoing MS [Time frame: Baseline and 6 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

United States · 2 centers

Pennington Biomedical Resarch Center — Baton Rouge
Pennington Biomedical Research Center — Baton Rouge

Publications

1. Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, De Luca M, Faria SL, Goodpaster KP, Haddad A, Himpens JM. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) indications for metabolic and bariatric surgery. 2. Courcoulas AP, Daigle CR, Arterburn DE. Long term outcomes of metab

Identifiers

NCT: NCT07530718 · 2025-012

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗