Heterogeneous Fatty Acid-Binding Protein 4 (FABP4) Responses After Roux-en-Y Gastric Bypass: A Retrospective Observational Cohort Study of Adipokine Remodeling Dissociated From Weight Loss, Inflammation, and Incretin Dynamics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Measure: Change in serum FABP4 level from baseline to 6 months after RYGB
研究概览
简要总结
This retrospective observational cohort study examined serum fatty acid-binding protein 4 (FABP4) dynamics in 28 adults who underwent Roux-en-Y gastric bypass (RYGB), followed at baseline, 3 months, and 6 months. Anthropometric, metabolic, and inflammatory parameters were assessed alongside FABP4, fasting GLP-1, and PYY. Patients were classified as FABP4 responders (decrease from baseline to 6 months) or rebound/non-responders. The study investigated whether FABP4 trajectory after RYGB is associated with the magnitude of weight loss, systemic inflammation, and fasting incretin change.
详细描述
Sixteen of the 28 participants had previously been enrolled in the control (probiotic-only, non-prebiotic) arm of a completed, registered randomized trial of pre-/probiotic supplementation after RYGB at the same institution (ClinicalTrials.gov Identifier: NCT03517345); these participants received no prebiotic intervention. The remaining 12 participants underwent RYGB by the same surgeon during a comparable period and were not enrolled in that trial. Blood samples from both subgroups had originally been collected and stored at -80°C as part of their respective prospective clinical follow-up. FABP4 concentrations were subsequently measured in these banked, single freeze-thaw samples using a commercial ELISA assay, blinded to patients' weight-loss and inflammatory outcomes, and merged with the anthropometric and biochemical data collected at the corresponding original visits. Because FABP4 assay and the present statistical analysis were performed after clinical follow-up had already been completed for both subgroups, this study is registered retrospectively.
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 who underwent Roux-en-Y gastric bypass (RYGB), performed by a single surgeon
- •Completed baseline, 3-month, and 6-month clinical and anthropometric assessments
排除标准
- •Use of GLP-1 receptor agonists at any study time point
- •Use of insulin at any study time point
- •Missing 6-month FABP4 measurement (excluded from FABP4-based longitudinal/group analyses; n=1)
结局指标
主要结局
Measure: Change in serum FABP4 level from baseline to 6 months after RYGB
时间窗: Time Frame: Baseline, 3 months, 6 months
Description: FABP4 measured by ELISA; patients classified as responders (decrease) vs. rebound/non-responders (no decrease or increase)
次要结局
- Change in BMI from baseline to 3 and 6 months(Baseline, 3 months, 6 months)
- Change in body weight from baseline to 3 and 6 months(Baseline, 3 months, 6 months)
- Change in fat mass (bioelectrical impedance) from baseline to 3 and 6 months(Baseline, 3 months, 6 months)
- Change in fat-free mass (bioelectrical impedance) from baseline to 3 and 6 months(Baseline, 3 months, 6 months)
- Change in HOMA-IR from baseline to 3 and 6 months(Baseline, 3 months, 6 months)
- Change in IL-6 from baseline to 3 and 6 months(Baseline, 3 months, 6 months)
- Change in hsCRP from baseline to 3 and 6 months(Baseline, 3 months, 6 months)
- Change in fasting GLP-1 from baseline to 3 and 6 months(Baseline, 3 months, 6 months)
- Change in fasting PYY from baseline to 3 and 6 months(Baseline, 3 months, 6 months)
- Baseline-Adjusted 6-Month Change in Body Mass Index (BMI) by FABP4 Response Group(Baseline, 3 months, 6 months)
- Odds Ratios for Predictors of 6-Month FABP4 Rebound: Early (0-3-Month) BMI Change, Age, and Sex(Baseline, 3 months, 6 months)
研究者
Fulya Calikoglu
Lecturer
Istanbul University