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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.
See attached protocol for detailed study design, eligibility criteria, and outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight and BMI | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yu Lu, MD, PhD | The Affiliated Hospital of Qingdao University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao University Affiliated Hospital | Qingdao | Shandong | 266003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31841552 | Background | Silva Junior MF, Batista MJ, de Sousa MDLR. Correction: Risk factors for tooth loss in adults: A population-based prospective cohort study. PLoS One. 2019 Dec 16;14(12):e0226794. doi: 10.1371/journal.pone.0226794. eCollection 2019. | |
| 32813948 | 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. |
| Label | URL |
|---|---|
| American Society for Metabolic and Bariatric Surgery | View source |
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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 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.
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:
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.
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|
| Change in Pancreatic Fat Distribution (Head, Body, Tail) | 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 | 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) |
| 18379446 | 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. |
| 24057293 | 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. |
| 37272316 | 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. |
| 29221645 | 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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
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