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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07241741
Acronym
PTX3-BYPASS
Enrollment
23
Registered
2025-11-21
Start date
2015-01-01
Completion date
2025-09-01
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Days to 65 Days
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

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

Design outcomes

Primary

MeasureTime frameDescription
Change in HOMA-IR from baseline to 6 monthsBaseline, 3 months, 6 monthsAssessment 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

MeasureTime frameDescription
Percent Excess Weight Loss (%EWL) at 6 months6 monthsEvaluation of weight loss outcomes after surgery, calculated as percent excess weight loss (%EWL). Comparisons will be made between PTX3 high vs. low groups.
CRP normalization at 6 months6 monthsProportion of patients achieving CRP ≤5 mg/L after surgery. Predictive value of baseline PTX3 will be assessed.
Change in IL-6 from baseline to 6 monthsBaseline, 3 months, 6 monthsChange in serum IL-6 levels after surgery, analyzed between PTX3 high vs. low groups.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026