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

NCT07464223 | Active Not Recruiting

• 1 other identifier: QYFYEC2024-233
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight; Type 2 Diabetes Mellitus (T2DM); Pancreatic Steatosis; Insulin Resistance

Keywords

Bariatric Surgery; Sleeve Gastrectomy; Pancreatic Fat; MRI; Dixon Imaging; Islet Function; Insulin Secretion; Metabolic Surgery; Diabetes Remission

Outcome Measures

Primary Outcomes (3)

• Change in Pancreatic Fat Content

  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)

  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

  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 Outcomes (3)

• 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)

Study Arms (1)

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)

Interventions

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.

Obese patients undergoing LSG

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• yu li，MD: lead

Study Sites (1)

Qingdao University Affiliated Hospital

Qingdao, Shandong, 266003, China

Location

Related Publications (6)

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  PMID: 31841552 BACKGROUND

• Yoshino M, Kayser BD, Yoshino J, Stein RI, Reeds D, Eagon JC, Eckhouse SR, Watrous JD, Jain M, Knight R, Schechtman K, Patterson BW, Klein S. Effects of Diet versus Gastric Bypass on Metabolic Function in Diabetes. N Engl J Med. 2020 Aug 20;383(8):721-732. doi: 10.1056/NEJMoa2003697.

  PMID: 32813948 BACKGROUND

• Vieira-Leite-Segundo A, Lima Falcao MF, Correia-Lins Filho R, Marques Soares MS, Lopez Lopez J, Chimenos Kustner E. Multiple myeloma with primary manifestation in the mandible: a case report. Med Oral Patol Oral Cir Bucal. 2008 Apr 1;13(4):E232-4.

  PMID: 18379446 BACKGROUND

• Nannipieri M, Baldi S, Mari A, Colligiani D, Guarino D, Camastra S, Barsotti E, Berta R, Moriconi D, Bellini R, Anselmino M, Ferrannini E. Roux-en-Y gastric bypass and sleeve gastrectomy: mechanisms of diabetes remission and role of gut hormones. J Clin Endocrinol Metab. 2013 Nov;98(11):4391-9. doi: 10.1210/jc.2013-2538. Epub 2013 Sep 20.

  PMID: 24057293 BACKGROUND

• De Luca M, Zese M, Bandini G, Chiappetta S, Iossa A, Merola G, Piatto G, Tolone S, Vitiello A, Silverii GA, Ragghianti B, Mannucci E, Monami M; Expert Panel and Evidence Review Team for the Italian Guidelines on Bariatric and Metabolic Surgery. Metabolic bariatric surgery as a therapeutic option for patients with type 2 diabetes: A meta-analysis and network meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2023 Aug;25(8):2362-2373. doi: 10.1111/dom.15117. Epub 2023 Jun 5.

  PMID: 37272316 BACKGROUND

• Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.

  PMID: 29221645 BACKGROUND

Related Links

• American Society for Metabolic and Bariatric Surgery

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Yu Lu, MD, PhD

  The Affiliated Hospital of Qingdao University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Gastrointestinal Surgery, Vice Chief Physician

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start: September 1, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

CN (1)