ONE-YEAR OUTCOMES OF ANTHROPOMETRIC, BIOCHEMICAL, AND NUTRITIONAL PARAMETERS AFTER CONVERSION BARIATRIC SURGERY
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Body Composition Parameters
研究概览
简要总结
Obesity is a growing global public health problem, and bariatric surgery is currently the most effective treatment for achieving sustained weight loss and improving obesity-related comorbidities. However, a subset of patients experience inadequate weight loss or weight regain following primary bariatric surgery, which may lead to the recurrence of metabolic complications and reduced quality of life. In such cases, conversion bariatric surgery, defined as the surgical conversion from one bariatric procedure to another, is considered an important therapeutic option. Despite the increasing number of conversion procedures, comprehensive longitudinal data evaluating anthropometric, biochemical, and nutritional outcomes after conversion bariatric surgery remain limited.
This study aims to prospectively evaluate individuals undergoing conversion bariatric surgery due to weight regain following primary bariatric surgery. Anthropometric measurements, biochemical parameters, and nutritional status will be assessed preoperatively and at 1 year after surgery. By evaluating weight loss outcomes together with metabolic and nutritional changes, this study seeks to provide clinically relevant evidence to guide postoperative follow-up strategies, optimize nutritional management, and support multidisciplinary care in patients undergoing conversion bariatric surgery.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-45 years
- •Previously underwent bariatric surgery
- •Subsequently underwent conversion bariatric surgery due to suboptimal clinical response
- •Suboptimal clinical response defined as either:
- •Suboptimal Clinical Response (SCR): maximum total weight loss (TWL%) of <20% within 18 months after metabolic and bariatric surgery
- •Recurrent Weight Gain (RWG): regaining >30% of initial postoperative weight loss after achieving initial weight reduction
排除标准
- •Pregnancy or lactation
- •Presence of acute illness or infection
- •Comorbid conditions that could limit treatment efficacy or compromise safety
- •Participation in professional athletic activity
研究组 & 干预措施
Conversion Bariatric Surgery
This cohort includes patients who previously underwent conversion bariatric surgery as part of routine clinical care and were followed observationally. Anthropometric measurements, biochemical parameters, and nutritional status were assessed at the preoperative period and postoperative month 12 (1 year).
结局指标
主要结局
Change in Body Composition Parameters
时间窗: Preoperative baseline and postoperative 1 year
Body composition parameters including fat mass, fat percentage, fat-free mass, fat-free mass percentage, skeletal muscle mass, muscle percentage, and extracellular water to total body water ratio assessed using multi-frequency bioelectrical impedance analysis (BIA).
Change in Body Weight
时间窗: Preoperative baseline and postoperative 1 year
Change in body weight (kg) measured using a digital scale with participants wearing light clothing and no shoes.
Change in Body Mass Index (BMI)
时间窗: Preoperative baseline and postoperative 1 year
Change in body mass index (kg/m²) calculated from measured body weight and height.
Percentage of Total Weight Loss
时间窗: postoperative 1 year
Percentage of total weight loss calculated as \[(preoperative weight - postoperative weight) / preoperative weight\] × 100.
Percentage of Excess Weight Loss
时间窗: postoperative 1 year
Percentage of excess weight loss calculated as \[(preoperative weight - postoperative weight) / (preoperative weight - ideal body weight)\] × 100, with ideal body weight defined as a BMI of 25 kg/m².
Change in Waist Circumference
时间窗: Preoperative baseline and postoperative 1 year
Waist circumference (cm) measured in the standing position using a non-elastic measuring tape at the midpoint between the lowest rib and the iliac crest.
Change in Hip Circumference
时间窗: Preoperative baseline and postoperative 1 year
Hip circumference (cm) measured in the standing position at the point of maximum protrusion of the gluteal muscles using a non-elastic measuring tape.
Change in Body Fat Percentage (%)
时间窗: Preoperative baseline and postoperative 1 year
Body fat percentage measured using multi-frequency bioelectrical impedance analysis (BIA).
Change in Fat-Free Mass (kg)
时间窗: Preoperative baseline and postoperative 1 year
Fat-free mass measured using multi-frequency bioelectrical impedance analysis (BIA).
Change in Skeletal Muscle Mass (kg)
时间窗: Preoperative baseline and postoperative 1 year
Skeletal muscle mass measured using multi-frequency bioelectrical impedance analysis (BIA).
次要结局
- Change in Fasting Plasma Glucose(Preoperative baseline and postoperative 1 year)
- Change in Alanine Aminotransferase (ALT)(Preoperative baseline and postoperative 1 year)
- Change in Hematological Parameters(Preoperative baseline and postoperative 1 year)
- Change in Iron Status Parameters(Preoperative baseline and postoperative 1 year)
- Change in Micronutrient and Electrolyte Levels(Preoperative baseline and postoperative 1 year)
- Change in Fasting Insulin(Preoperative baseline and postoperative 1 year)
- Change in Glycated Hemoglobin (HbA1c)(Preoperative baseline and postoperative 1 year)
- Change in Total Cholesterol(Preoperative baseline and postoperative 1 year)
- Change in LDL Cholesterol(Preoperative baseline and postoperative 1 year)
- Change in HDL Cholesterol(Preoperative baseline and postoperative 1 year)
- Change in Triglyceride Levels(Preoperative baseline and postoperative 1 year)
- Change in Aspartate Aminotransferase (AST)(Preoperative baseline and postoperative 1 year)
- Change in Urea Levels(Preoperative baseline and postoperative 1 year)
- Change in Uric Acid Levels(Preoperative baseline and postoperative 1 year)
研究者
Seher Şen
Assistant Professor, Principal Investigator
Mudanya University