8-Year Outcomes After Sleeve Gastrectomy: Anthropometric, Biochemical, and Nutritional Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Fat Mass
研究概览
简要总结
Obesity is a major global public health concern, and bariatric surgery is recognized as the most effective treatment for achieving sustained weight loss and improving obesity-related comorbidities. Sleeve gastrectomy (SG) is one of the most commonly performed bariatric procedures; however, long-term outcomes vary considerably among individuals. While some patients maintain satisfactory weight loss, others experience suboptimal weight loss or weight regain several years after surgery. Evidence suggests that long-term weight trajectories after SG may be influenced by metabolic changes, dietary habits, and lifestyle factors, highlighting the need for extended follow-up studies.
This observational cohort study aims to evaluate the long-term outcomes of individuals who underwent sleeve gastrectomy approximately 8 years ago. Anthropometric measurements, biochemical parameters, and nutritional status will be reassessed at an 8-year follow-up visit and compared with data obtained during the preoperative period and at postoperative 6 months. By examining within-subject changes over time, this study seeks to provide insight into the long-term sustainability of weight loss after sleeve gastrectomy and to identify metabolic and nutritional factors associated with long-term outcomes.
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 18-65 years
- •Patients who underwent sleeve gastrectomy approximately 8 years prior to study enrollment
- •Patients with available postoperative follow-up data at 6 months, including anthropometric measurements, biochemical parameters, and nutritional status assessments
- •Patients willing to participate in long-term follow-up and attend in-person evaluations
排除标准
- •Pregnancy or lactation
- •Presence of acute illness or active infection at the time of evaluation
- •Presence of acute illness, infection, or comorbid conditions that may limit study safety or validity, including malignancy, type 1 diabetes mellitus, renal or hepatic failure, recent stroke or myocardial infarction, nephrolithiasis, drug or alcohol abuse, eating disorders, severe depression or other major psychiatric disorders, inflammatory bowel disease, cardiac arrhythmias or heart failure, respiratory failure, or chronic systemic corticosteroid therapy.
- •Professional athletes
研究组 & 干预措施
Sleeve Gastrectomy Long-Term Follow-up Cohort
This cohort includes adults who underwent sleeve gastrectomy between 2016 and 2017 and were re-evaluated approximately 8 years after surgery. Participants are followed observationally, with anthropometric measurements, biochemical parameters, and nutritional status assessed preoperatively, at postoperative 6 months, and at long-term (8-year) follow-up. No intervention is assigned as part of the study protocol; all surgical procedures were performed as part of routine clinical care.
结局指标
主要结局
Change in Fat Mass
时间窗: Preoperative, postoperative 6 months, and postoperative 8 years
Changes in fat mass measured using multi-frequency bioelectrical impedance analysis (BIA).
Change in Body Weight
时间窗: Preoperative, postoperative 6 months, and postoperative 8 years
Body weight measured using a calibrated digital scale with participants wearing light clothing and no shoes.
Change in Body Mass Index (BMI)
时间窗: Preoperative, postoperative 6 months, and postoperative 8 years
BMI calculated as weight in kilograms divided by height in meters squared (kg/m²), measured using a wall-mounted stadiometer.
Change in Waist Circumference
时间窗: Preoperative, postoperative 6 months, and postoperative 8 years
Waist circumference measured in centimeters at the midpoint between the subcostal margin and the iliac crest with participants standing upright.
Change in Hip Circumference
时间窗: Preoperative, postoperative 6 months, and postoperative 8 years
Hip circumference measured in centimeters at the level of maximum gluteal protrusion.
Percent Total Weight Loss (TWL%)
时间窗: Postoperative 6 months and postoperative 8 years
Calculated as \[(preoperative weight - postoperative weight) / preoperative weight\] × 100.
Percent Excess Weight Loss (EWL%)
时间窗: Postoperative 6 months and postoperative 8 years
Calculated as \[(preoperative weight - postoperative weight) / (preoperative weight - ideal body weight)\] × 100, where ideal body weight corresponds to a BMI of 25 kg/m².
Change in Body Fat Percentage
时间窗: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in body fat percentage measured using multi-frequency bioelectrical impedance analysis (BIA).
Change in Skeletal Muscle Mass
时间窗: Preoperative baseline, postoperative 6 months, and postoperative 8 years
Changes in skeletal muscle mass measured using multi-frequency bioelectrical impedance analysis (BIA).
次要结局
- Change in Fasting Plasma Glucose(Preoperative, postoperative 6 months, and postoperative 8 years)
- Change in Fasting Insulin Levels(Preoperative, postoperative 6 months, and postoperative 8 years)
- Change in Glycated Hemoglobin (HbA1c)(Preoperative, postoperative 6 months, and postoperative 8 years)
- Change in Lipid Profile Parameters(Preoperative, postoperative 6 months, and postoperative 8 years)
- Change in Liver Enzyme Levels(Preoperative, postoperative 6 months, and postoperative 8 years)
- Change in Renal and Metabolic Biomarkers(Preoperative, postoperative 6 months, and postoperative 8 years)
- Change in Serum Albumin(Preoperative, postoperative 6 months, and postoperative 8 years)
- Change in Micronutrient Levels(Preoperative, postoperative 6 months, and postoperative 8 years)
- Change in Physical Activity Level(Preoperative, postoperative 6 months, and postoperative 8 years)
- Change in Fat-Free Mass(Preoperative baseline, postoperative 6 months, and postoperative 8 years)
- Change in Total Protein(Preoperative baseline, postoperative 6 months, and postoperative 8 years)
- Change in Hemoglobin(Preoperative baseline, postoperative 6 months, and postoperative 8 years)
- Change in Hematocrit(Preoperative baseline, postoperative 6 months, and postoperative 8 years)
- Change in Serum Ferritin(Preoperative baseline, postoperative 6 months, and postoperative 8 years)
- Change in Serum Iron(Preoperative baseline, postoperative 6 months, and postoperative 8 years)
研究者
Seher Şen
Assist. Prof. Dr.
Medipol University