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Completed

NCT Number: NCT07241741

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

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.

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Key information

Conditions

Obesity Body Weight C-reactive Protein Chronic Inflammation Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Interleukin-6 Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Roux En Y Gastric Bypass Signs and Symptoms

Age range

18 day–65 day

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Pentraxin-3 (PTX3) Grouping

Primary outcomes

  1. Change in HOMA-IR from baseline to 6 months

    Time frame: 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 outcomes

  1. Percent Excess Weight Loss (%EWL) at 6 months

    Time frame: 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.

  2. CRP normalization at 6 months

    Time frame: 6 months

    Proportion of patients achieving CRP ≤5 mg/L after surgery. Predictive value of baseline PTX3 will be assessed.

  3. Change in IL-6 from baseline to 6 months

    Time frame: Baseline, 3 months, 6 months

    Change in serum IL-6 levels after surgery, analyzed between PTX3 high vs. low groups.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

A Single-Center Prospective Study on PTX3 as a Predictor of Insulin Resistance and Inflammatory Resolution After Bariatric Surgery

Acronym: PTX3-BYPASS

Important dates

Study start
2015
Primary completion
2015
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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