A Longitudinal Study Based on MRI to Evaluate the Changes of Pancreatic Fat and the Recovery of Pancreatic Function in Obese Patients After 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
- 50
- 试验地点
- 1
- 主要终点
- Change in Pancreatic Fat Content
研究概览
简要总结
This study evaluates changes in pancreatic fat and recovery of pancreatic function in obese patients undergoing laparoscopic sleeve gastrectomy (LSG), a weight-loss surgery.
Obesity can cause fat to accumulate in the pancreas, which may impair insulin production and lead to type 2 diabetes. This study uses magnetic resonance imaging (MRI) to measure pancreatic fat before and after surgery to understand how weight loss affects pancreatic function.
About 50 obese patients (BMI > 32 kg/m²) aged 16-60 years who are scheduled for LSG will be enrolled. Participants will undergo MRI scans of the pancreas and blood tests before surgery and at 1, 3, and 6 months after surgery. The MRI uses a safe, non-invasive technique called Dixon imaging to measure fat content in different parts of the pancreas (head, body, and tail). Blood tests will measure fasting glucose, insulin, C-peptide, and HbA1c to assess pancreatic function.
The study aims to determine whether reduction in pancreatic fat after weight-loss surgery is associated with improved insulin secretion and reduced insulin resistance. This information may help doctors better understand how bariatric surgery improves metabolic health and guide postoperative patient management.
Participation involves no additional risk beyond routine clinical care. All MRI scans and blood tests are part of standard postoperative monitoring for bariatric surgery patients.
详细描述
See attached protocol for detailed study design, eligibility criteria, and outcome measures.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 16 and 60 years
- •BMI > 32 kg/m²
- •Preoperative auxiliary examination supports diagnosis of pancreatic fat infiltration
- •Willing to undergo pancreatic MRI examination
- •Previous attempts at other weight loss methods have been ineffective
- •Complete medical records available
- •Voluntary signed informed consent
- •Scheduled to undergo laparoscopic sleeve gastrectomy (LSG) at Qingdao University Affiliated Hospital
排除标准
- •Secondary obesity
- •Previous major gastrointestinal surgery
- •Diagnosed gastric or duodenal ulcer
- •Gastrointestinal diseases associated with malabsorption
- •Other diseases causing abnormal pancreatic function
- •BMI < 32 kg/m²
- •Poor compliance or self-control, unable to follow dietary guidance after surgery
- •Unable to complete follow-up visits
- •Contraindications for MRI examination
- •Pregnancy or lactation
研究组 & 干预措施
Obese patients undergoing LSG
Obese patients (BMI > 32 kg/m²) aged 16-60 years undergoing laparoscopic sleeve gastrectomy (LSG), with pancreatic fat infiltration confirmed by preoperative MRI. Participants will be assessed at baseline (preoperative) and at 1, 3, and 6 months postoperatively.
干预措施: Laparoscopic Sleeve Gastrectomy (LSG) (Procedure)
结局指标
主要结局
Change in Pancreatic Fat Content
时间窗: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Pancreatic fat fraction will be measured using MRI Dixon imaging at pancreatic head, body, and tail. Fat fraction (%) = \[(SI in-phase - SI opposed-phase) / (2 × SI in-phase)\] × 100.
Change in Insulin Resistance Index (HOMA-IR)
时间窗: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Insulin resistance will be assessed using the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) calculated as: \[fasting plasma glucose (mmol/L) × fasting insulin (μU/mL)\] / 22.5. Fasting plasma glucose will be measured by glucose oxidase method and fasting insulin will be measured by chemiluminescence immunoassay. Higher HOMA-IR values indicate greater insulin resistance.
Change in Pancreatic Beta-cell Function
时间窗: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
Pancreatic beta-cell function will be assessed using HOMA-%β (Homeostasis Model Assessment for beta-cell function) calculated as: HOMA-%β = \[20 × fasting insulin (μU/mL)\] / \[fasting glucose (mmol/L) - 3.5\] (%). Fasting blood glucose, fasting insulin, C-peptide, and HbA1c will be measured at each time point.
次要结局
- Change in Body Weight and BMI(Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively)
- Change in Pancreatic Fat Distribution (Head, Body, Tail)(Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively)
- Correlation Between Pancreatic Fat Reduction and Islet Function Recovery(Baseline to 6 months postoperatively (change scores will be calculated))
研究者
yu li，MD
Associate Professor, Department of Gastrointestinal Surgery, Vice Chief Physician
The Affiliated Hospital of Qingdao University