A Single-Center Prospective Study on PTX3 as a Predictor of Insulin Resistance and Inflammatory Resolution After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Change in HOMA-IR from baseline to 6 months
研究概览
简要总结
This study evaluated the prognostic value of preoperative pentraxin-3 (PTX3) levels in predicting weight loss, inflammatory resolution (CRP, IL-6), and metabolic improvements (HOMA-IR) following Roux-en-Y gastric bypass in patients with obesity.
详细描述
This single-center longitudinal study was conducted at Istanbul University Hospital. A total of 23 patients undergoing primary Roux-en-Y gastric bypass were included. PTX3 levels were measured preoperatively, and patients were stratified according to a data-derived cut-off (~21.7 ng/mL). Outcomes assessed at baseline, 3 months, and 6 months included body weight, BMI, excess weight loss (%EWL), fasting insulin, HOMA-IR, CRP, and IL-6. The primary hypothesis was that preoperative PTX3 would predict postoperative CRP normalization and insulin resistance improvement.
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 Days 至 65 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •Body mass index (BMI) ≥40 kg/m², or BMI ≥35 kg/m² with obesity-related comorbidity
- •Eligible for primary Roux-en-Y gastric bypass
- •Able to provide written informed consent
排除标准
- •Previous bariatric surgery
- •Severe hepatic, renal, or cardiac failure
- •Active infection or inflammatory disease
- •Malignancy
结局指标
主要结局
Change in HOMA-IR from baseline to 6 months
时间窗: Baseline, 3 months, 6 months
Assessment of the improvement in insulin resistance after Roux-en-Y gastric bypass, measured by the homeostasis model assessment of insulin resistance (HOMA-IR). Preoperative PTX3 stratification will be used to evaluate predictive value.
次要结局
- Percent Excess Weight Loss (%EWL) at 6 months(6 months)
- CRP normalization at 6 months(6 months)
- Change in IL-6 from baseline to 6 months(Baseline, 3 months, 6 months)
研究者
Fulya Calikoglu
Lecturer
Istanbul University