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

NCT ID: NCT07241741

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2025-09-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: High PTX3 (≥21.7 ng/mL)

Participants with preoperative serum PTX3 levels ≥21.7 ng/mL. All patients underwent Roux-en-Y gastric bypass and were followed prospectively for 6 months with metabolic and inflammatory assessments.

Biomarker Stratification by PTX3

Intervention Type: OTHER

Participants were stratified into groups according to preoperative serum PTX3 levels (≥21.7 ng/mL vs. \<21.7 ng/mL). All participants underwent Roux-en-Y gastric bypass and were prospectively evaluated for metabolic (HOMA-IR, %EWL) and inflammatory (CRP, IL-6) outcomes during 6 months of follow-up.

Group 2: Low PTX3 (<21.7 ng/mL)

Participants with preoperative serum PTX3 levels \<21.7 ng/mL. All patients underwent Roux-en-Y gastric bypass and were followed prospectively for 6 months with metabolic and inflammatory assessments.

Biomarker Stratification by PTX3

Intervention Type: OTHER

Participants were stratified into groups according to preoperative serum PTX3 levels (≥21.7 ng/mL vs. \<21.7 ng/mL). All participants underwent Roux-en-Y gastric bypass and were prospectively evaluated for metabolic (HOMA-IR, %EWL) and inflammatory (CRP, IL-6) outcomes during 6 months of follow-up.

Interventions

Biomarker Stratification by PTX3

Participants were stratified into groups according to preoperative serum PTX3 levels (≥21.7 ng/mL vs. \<21.7 ng/mL). All participants underwent Roux-en-Y gastric bypass and were prospectively evaluated for metabolic (HOMA-IR, %EWL) and inflammatory (CRP, IL-6) outcomes during 6 months of follow-up.

Intervention Type: OTHER

Other Intervention Names

Pentraxin-3 (PTX3) Grouping

Eligibility Criteria

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

• Minimum Eligible Age: 18 Days
• Maximum Eligible Age: 65 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Fulya Calikoglu

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ITF_2025_09

Identifier Type: -

Identifier Source: org_study_id