MRI Assessment of Pancreatic Fat Changes and Islet Function Recovery After Bariatric Surgery in Obese Patients (PANFAT-BS)

March 11, 2026 updated by: yu li，MD

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266003
        • Qingdao University Affiliated Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Obese patients aged 16-60 years with BMI >32 kg/m² undergoing laparoscopic sleeve gastrectomy at Qingdao University Affiliated Hospital. Participants must have preoperative evidence of pancreatic fat infiltration and complete medical records. Both male and female patients are eligible.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Laparoscopic Sleeve Gastrectomy (LSG)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
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.
Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
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.
Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
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.
Baseline (preoperative), 1 month, 3 months, and 6 months postoperatively
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.
Baseline to 6 months postoperatively (change scores will be calculated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

yu li，MD

Investigators

  • Study Chair: Yu Lu, MD, PhD, The Affiliated Hospital Of Qingdao University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QYFYEC2024-233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying published results will be shared upon reasonable request to the corresponding author (Dr. Yu Li, Liyu11920@hotmail.com) after publication of primary results.

Data sharing will begin: 12 months after publication of primary results Data will be shared with: Researchers who provide a methodologically sound proposal Data sharing mechanism: Secure file transfer or email Types of data to be shared: De-identified participant-level data, data dictionary, and statistical analysis plan Supporting documents: Study protocol and informed consent form will be available upon request

IPD Sharing Time Frame

IPD and supporting information will be available beginning 12 months after publication of primary results. Data will be available for a period of 5 years from the start date. The anticipated start date for data sharing is June 2026, following completion of primary data analysis and publication of main findings.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal will be able to access de-identified individual participant data upon reasonable request to the corresponding author (Dr. Yu Li, email: Liyu11920@hotmail.com).

Access requirements:

  1. Submission of a research proposal outlining the scientific rationale and analysis plan
  2. Approval by the study steering committee
  3. Signing of a data access agreement ensuring data confidentiality and appropriate use

Data will be shared via secure file transfer or encrypted email. Supporting documents (study protocol, statistical analysis plan, informed consent form) will be provided alongside the dataset.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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