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CompletedNCT07241741PTX3-BYPASSUpdated Nov 21, 2025

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

An observational study in Obesity, Metabolic Syndrome and Insulin Resistance, sponsored by Istanbul University. Completed. Open to participants aged 18 Days to 65 Days. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Istanbul University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
23
Ages
18 Days to 65 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 23 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Days to 65 Days
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

  • Previous bariatric surgery
  • Severe hepatic, renal, or cardiac failure
  • Active infection or inflammatory disease
  • Malignancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
23 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherBiomarker 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.

    Also known as: Pentraxin-3 (PTX3) Grouping

06

What researchers measure

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.

    Time frame: Baseline, 3 months, 6 months

Secondary outcomes

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

    Time frame: 6 months

  2. CRP normalization at 6 months

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

    Time frame: 6 months

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

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

    Time frame: Baseline, 3 months, 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — The study team does not plan to share individual participant data at this time.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07241741
Lead sponsor
Istanbul University
Responsible party
Fulya Calikoglu (Lecturer, Istanbul University) — Principal investigator
First posted
Nov 21, 2025
Start date
Jan 1, 2015
Primary completion
Jul 1, 2015
Completion
Sep 1, 2025
Last update
Nov 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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