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

NCT07241741 | Completed

• 1 other identifier: ITF_2025_09
• Study Type: observational
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Pentraxin-3 (PTX3); Insulin Resistance; HOMA-IR; C-Reactive Protein (CRP); Bariatric Surgery; Roux-en-Y Gastric Bypass; Metabolic Outcomes; Inflammatory Biomarkers; Predictive Biomarker

Outcome Measures

Primary Outcomes (1)

• Change in HOMA-IR from baseline to 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.

  Baseline, 3 months, 6 months

Secondary Outcomes (3)

• Percent Excess Weight Loss (%EWL) at 6 months

  6 months

• CRP normalization at 6 months

  6 months

• Change in IL-6 from baseline to 6 months

  Baseline, 3 months, 6 months

Study Arms (2)

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.

Other: Biomarker Stratification by PTX3

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.

Other: Biomarker Stratification by PTX3

Interventions

Biomarker Stratification by PTX3 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.

Also known as: Pentraxin-3 (PTX3) Grouping

Group 1: High PTX3 (≥21.7 ng/mL); Group 2: Low PTX3 (<21.7 ng/mL)

Eligibility Criteria

• Age: 18 Days - 65 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adults with obesity scheduled to undergo primary Roux-en-Y gastric bypass at Istanbul University Hospital. Sexes Eligible for Study: All Gender-Based: No Accepts Healthy Volunteers: No

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Insulin Resistance; Inflammation

Interventions

PTX3 protein

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: November 21, 2025
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share