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NCT Number: NCT07464223

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity & Overweight Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pancreatic Steatosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Mellitus (T2DM)

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qingdao University Affiliated Hospital

Qingdao, Shandong, 266003, China

About this study

See attached protocol for detailed study design, eligibility criteria, and outcome measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Change in Pancreatic Fat Content

    Time frame: 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.

  2. Change in Insulin Resistance Index (HOMA-IR)

    Time frame: 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.

  3. Change in Pancreatic Beta-cell Function

    Time frame: 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.

Secondary outcomes

  1. Change in Body Weight and BMI

    Time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively

    Body weight will be measured using calibrated electronic scales with subjects wearing light clothing and no shoes. Height will be measured using a stadiometer. BMI will be calculated as weight (kg) divided by height squared (m²). Percentage of total weight loss (%TWL) and percentage of excess weight loss (%EWL) will also be calculated to assess surgical efficacy.

  2. Change in Pancreatic Fat Distribution (Head, Body, Tail)

    Time frame: Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively

    Regional pancreatic fat content will be measured separately at pancreatic head, body, and tail using MRI Dixon imaging. Three regions of interest (ROI) will be drawn at the maximal cross-sectional area of each pancreatic segment. Fat fraction (%) = [(SI in-phase - SI opposed-phase) / (2 × SI in-phase)] × 100. This allows assessment of differential fat reduction patterns across pancreatic regions and correlation with regional islet function recovery.

  3. Correlation Between Pancreatic Fat Reduction and Islet Function Recovery

    Time frame: Baseline to 6 months postoperatively (change scores will be calculated)

    Correlation analysis between the magnitude of pancreatic fat reduction (measured by MRI Dixon) and improvement in islet function parameters (HOMA-%β, HOMA-IR, fasting insulin, C-peptide). This will identify whether pancreatic fat reduction is an independent predictor of beta-cell function recovery after laparoscopic sleeve gastrectomy.

Sponsors and collaborators

Lead sponsor

yu li，MD

Other

Registry information

Official study title

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

Acronym: PANFAT-BS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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