The Predictive Role of Preoperative Pentraxin-3 (PTX3) in Metabolic and Inflammatory Outcomes After Roux-en-Y Gastric Bypass

Completed

• Conditions: Obesity; Metabolic Syndrome; Insulin Resistance; Inflammation; Roux en Y Gastric Bypass; Chronic Inflammation; C-Reactive Protein; Interleukin-6

• Registration Number: NCT07241741
• Lead Sponsor: Istanbul University

Brief Summary

This study evaluated the prognostic value of preoperative pentraxin-3 (PTX3) levels in predicting weight loss, inflammatory resolution (CRP, IL-6), and metabolic improvements (HOMA-IR) following Roux-en-Y gastric bypass in patients with obesity.

Detailed Description

This single-center longitudinal study was conducted at Istanbul University Hospital. A total of 23 patients undergoing primary Roux-en-Y gastric bypass were included. PTX3 levels were measured preoperatively, and patients were stratified according to a data-derived cut-off (\~21.7 ng/mL). Outcomes assessed at baseline, 3 months, and 6 months included body weight, BMI, excess weight loss (%EWL), fasting insulin, HOMA-IR, CRP, and IL-6. The primary hypothesis was that preoperative PTX3 would predict postoperative CRP normalization and insulin resistance improvement.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2015-07-01
• Study Completion: 2025-09-01
• Study First Submitted: 2025-09-03
• Status Verified: 2025-11
• Study First Submitted QC: 2025-11-20
• Last Update Submitted: 2025-11-20
• Study First Posted: 2025-11-21
• Last Update Posted: 2025-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Age: 18-65 years
• Body mass index (BMI) ≥40 kg/m², or BMI ≥35 kg/m² with obesity-related comorbidity
• Eligible for primary Roux-en-Y gastric bypass
• Able to provide written informed consent

Exclusion Criteria

• Previous bariatric surgery
• Severe hepatic, renal, or cardiac failure
• Active infection or inflammatory disease
• Malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HOMA-IR from baseline to 6 months	Baseline, 3 months, 6 months	Assessment of the improvement in insulin resistance after Roux-en-Y gastric bypass, measured by the homeostasis model assessment of insulin resistance (HOMA-IR). Preoperative PTX3 stratification will be used to evaluate predictive value.

Secondary Outcome Measures

Name	Time	Method
Percent Excess Weight Loss (%EWL) at 6 months	6 months	Evaluation of weight loss outcomes after surgery, calculated as percent excess weight loss (%EWL). Comparisons will be made between PTX3 high vs. low groups.
CRP normalization at 6 months	6 months	Proportion of patients achieving CRP ≤5 mg/L after surgery. Predictive value of baseline PTX3 will be assessed.
Change in IL-6 from baseline to 6 months	Baseline, 3 months, 6 months	Change in serum IL-6 levels after surgery, analyzed between PTX3 high vs. low groups.