此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Impact of MBS on Body Composition, Basal Metabolic Rates and Muscle Functions in Morbid Obese Patients (BARCOM)

2026年7月29日 更新者:Dr. Prakash Kumar Sasmal、All India Institute of Medical Sciences, Bhubaneswar

Impact of Bariatric Surgery on Body Composition, Basal Metabolic Rates and Muscle Functions in Morbid Obese Patients: A Prospective Observational Study

PRIMARY OBJECTIVE To evaluate the changes in body composition in morbid obese patients following bariatric and metabolic surgery

Secondary Objectives:

  1. To assess changes in BMR in obese patients following bariatric surgery
  2. To evaluate muscles strength and muscle performance parameters in obese patients following bariatric surgery
  3. To assess change in inflammatory and metabolic parameters following bariatric surgery In this study, morbidly obese patients undergoing bariatric surgery will be assessed at baseline and followed by 3rd and 6 months to evaluate various physiological and biochemical changes. Anthropometric measurements including height, weight, BMI, and waist-hip ratio will be recorded. Body composition will be assessed using Bioelectrical Impedance Analysis (BIA), which will provide data on percentage body fat (PBF), segmental muscle mass (SMM), segmental fat mass (SFM), and skeletal muscle index (SMI). Basal metabolic rate (BMR) will also be measured through BIA. Muscle strength will be evaluated using a hand grip dynamometer, while muscle performance will be assessed via gait speed using the 6-meter walk test. Inflammatory markers such as high-sensitivity C-reactive protein (HsCRP), erythrocyte sedimentation rate (ESR), and interleukin-6 (IL-6) will be analyzed. Additionally, metabolic parameters including thyroid-stimulating hormone (TSH), fasting and postprandial blood glucose, HbA1c, and lipid profile will be measured to understand the systemic effects of the surgery.

研究概览

地位

尚未招聘

详细说明

In this study, morbidly obese patients undergoing bariatric surgery will be assessed at baseline and followed by 3rd and 6 months to evaluate various physiological and biochemical changes

  1. Anthropometric Measurements:

    Height (Ht) - measured using a stadiometer Weight (Wt) - measured using a digital weighing scale Body Mass Index (BMI) - calculated as Weight/(Height)2. Kg/m² Waist-Hip Ratio (WHR) - using a measuring tape to assess fat distribution

  2. Body Composition Analysis. Body composition analysis will be done using multi-frequency BIA (model InBody370S). Cases will be asked to ensure sufficient hydration before undergoing BIA and patients with electrical implants will be refrained from using BIA. The machine will provide following parameter PBF (Percentage Body Fat) - to assess total fat content SMM (Segmental Muscle Mass) - to evaluate muscle mass in individual limbs and trunk SFM (Segmental Fat Mass) - to quantify regional fat distribution SMI (Skeletal Muscle Index) - to assess skeletal muscle mass adjusted for height
  3. Basal Metabolic Rate (BMR):

    Measured using BIA, Resting energy expenditure will be measured using an indirect colorimeter if feasible.

  4. Muscle Function Assessment:

    Muscle Strength: Upper limbs muscle strength will be assessed by using Hand held dynamometer, which will measure hand grip strength(HGS).Three readings will be taken at an interval of 1 minute of rest. The average of 3 readings will be taken as HGS for each arm.A value of less than 28 in men and less than 18 in women will be considered as low HGS(6).

    Muscle Performance:

    A 6 meter walk test is a reliable test to assess muscle function or physical performance. A gait speed of less than 1 metre/second will be considered as reduced physical performance

  5. Inflammatory Markers:

    Interleukin 6 (IL 6) High sensitivity C reactive protein (Hs CRP) Erythrocyte Sedimentation Rate (ESR)

  6. Metabolic Parameters:

In this study, a comprehensive panel of metabolic and biochemical parameters will be assessed to evaluate the systemic effects of bariatric surgery. Glycemic control will be monitored through FBS, PPBS and HbA1c. Thyroid function will be evaluated by measuring thyroid stimulating hormone (TSH). Renal function will be assessed using serum urea and creatinine levels, urine ACR, while liver function will be evaluated through total bilirubin, AST, ALT, ALP estimation. Lipid metabolism will be examined by measuring total cholesterol, triglycerides, LDLand HDL. Additionally, serum calcium, VitD3 will be included to monitor bone and mineral metabolism, which may be affected by significant weight loss or changes in nutritional status postoperatively. These parameters will provide a holistic view of the physiological changes and health improvements resulting from bariatric surgery.

Follow-up: 3 and 6 months postoperative

Statistical analysis plan:

Data will be managed in Microsoft Excel and analysed using SPSS version 26. Numerical data like BMR, fat mass, etc., will be shown as mean ± SD or median with range.Categorical values like gender and type of surgery will be expressed as percentages.Kolmogorov-Smirnov test will be used to check for normality of continuous variables.Depending on data type, either parametric or non-parametric tests will be applied. All final outcomes will be shown with 95% confidence intervals.A p-value of <0.05 will be kept as a significant threshold.

研究类型

观察性的

注册 (估计的)

21

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Prakash K Sasmal, MBBS, MS(General Surgery), FMB
  • 电话号码:+919438884255
  • 邮箱:drpksasmal@gmail.com

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

Morbidly obese patients undergoing bariatric / Metabolic surgery

描述

Inclusion Criteria:

  • BMI > 35 with or without obesity-related comorbidities Planned for Bariatric and Metabolic Surgery

Exclusion Criteria:

  • Known endocrine disorders (Cushing's and Untreated hypothyroidism)
  • History of prior bariatric surgery
  • Inability to comply with follow-up scheduleLost to follow-up before 3 months post-treatment

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Percentage Body Fat
大体时间:Baseline, 3 months, and 6 months
Percentage body fat will be measured using Bioelectrical Impedance Analysis (BIA).
Baseline, 3 months, and 6 months

次要结果测量

结果测量
措施说明
大体时间
Change in Skeletal Muscle Mass (kg)
大体时间:Baseline, 3 months, and 6 months
Skeletal Muscle Index will be calculated as appendicular skeletal muscle mass divided by height squared.
Baseline, 3 months, and 6 months
Change in Hand Grip Strength
大体时间:Baseline, 3 months, and 6 months
Hand grip strength will be measured using a calibrated hand dynamometer.
Baseline, 3 months, and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年2月16日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅