Outcome of Body Composition Assessment in Patients With Severe Obesity Undergoing Metabolic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).
研究概览
简要总结
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.
详细描述
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.
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Cohort 1
Roux-en-Y gastric bypass surgery
Cohort 2
Sleeve Gastrectomy
结局指标
主要结局
Evaluate the effectiveness of Bioimpedance Analysis (BIA) in assessing outcomes in patients with severe obesity undergoing metabolic surgery (MS).
时间窗: 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.
时间窗: 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 MS
时间窗: Baseline and 6 months
height in meters
Evaluate the effectiveness of anthropometric measurement tool in assessing outcomes in patients with severe obesity undergoing MS
时间窗: Baseline and 6 months
Measure waist circumference in cm
Evaluate the effectiveness of BIA measurement tool in assessing outcomes in patients with severe obesity undergoing MS
时间窗: Baseline 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 MS
时间窗: Baseline and 6 months
Hip circumference in cm
Evaluate the effectiveness of Six-Minute Walk testing in assessing outcomes in patients with severe obesity undergoing MS.
时间窗: 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 BodPod (Air Displacement Plethysmography) in assessing outcomes in patients with severe obesity undergoing MS
时间窗: Baseline and 6 months
Measure body volume in liters
Evaluate the effectiveness of Dual Energy X ray Absorptiometry (DXA) in assessing outcomes in patients with severe obesity undergoing MS
时间窗: Baseline and 6 months
Measure total fat mass in kg
Evaluate the effectiveness of DXA in assessing outcomes in patients with severe obesity undergoing MS
时间窗: Baseline 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).
时间窗: 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.
时间窗: Baseline and 6 months
Measure extracellular water in liters
Evaluate the effectiveness of 3D Optical Imaging in assessing outcomes in patients with severe obesity undergoing MS.
时间窗: Baseline and 6 months
Measure body volume in cm\^3
Evaluate the effectiveness Body MRI in assessing outcomes of body composition in assessing outcomes in patients with severe obesity undergoing MS
时间窗: Baseline and 6 months
Measure skeletal muscle mass volume in cm\^3
Evaluate the effectiveness of BodPod in assessing outcomes in patients with severe obesity undergoing MS.
时间窗: Baseline and 6 months
Measure body density in kilograms per cubic meter (kg/m\^3)
次要结局
未报告次要终点