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

November 20, 2025 updated by: Fulya Calikoglu, Istanbul University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITF_2025_09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study team does not plan to share individual participant data at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings