Impact of Bariatric Surgery on Body Composition, Basal Metabolic Rates and Muscle Functions in Morbid Obese Patients: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 21
- 主要终点
- Change in Percentage Body Fat
研究概览
简要总结
PRIMARY OBJECTIVE To evaluate the changes in body composition in morbid obese patients following bariatric and metabolic surgery
Secondary Objectives:
- To assess changes in BMR in obese patients following bariatric surgery
- To evaluate muscles strength and muscle performance parameters in obese patients following bariatric surgery
- 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.
详细描述
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:
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).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 35 with or without obesity-related comorbidities Planned for Bariatric and Metabolic Surgery
排除标准
- •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
结局指标
主要结局
Change in Percentage Body Fat
时间窗: Baseline, 3 months, and 6 months
Percentage body fat will be measured using Bioelectrical Impedance Analysis (BIA).
次要结局
- Change in Hand Grip Strength(Baseline, 3 months, and 6 months)
- Change in Skeletal Muscle Mass (kg)(Baseline, 3 months, and 6 months)
研究者
Dr. Prakash Kumar Sasmal
Professor of General Surgery
All India Institute of Medical Sciences, Bhubaneswar