Clinical trial

MRI Assessment of Pancreatic Fat Changes and Islet Function Recovery After Bariatric Surgery in Obese Patients

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07464223

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age16 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Type 2 Diabetes Mellitus (T2DM), Pancreatic Steatosis, Insulin Resistance

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

Laparoscopic Sleeve Gastrectomy (LSG)

Procedure

Standard laparoscopic sleeve gastrectomy performed by experienced surgeons. This is the routine clinical procedure for weight loss, not an experimental intervention. The study observes pancreatic fat changes and metabolic outcomes following this standard surgery.

Primary outcomes

Change in Pancreatic Fat ContentBaseline (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)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 FunctionBaseline (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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Qingdao University Affiliated Hospital🇨🇳 Qingdao, Shandong, China

Open map