ObesityPTX3-BYPASSNCT07241741
The Predictive Role of Preoperative Pentraxin-3 (PTX3) in Metabolic and Inflammatory Outcomes After Roux-en-Y Gastric Bypass
An observational study of Obesity and Metabolic Syndrome, run by Istanbul University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 days
- Conditions the study is for
- Obesity, Metabolic Syndrome, Insulin Resistance
- What is being tested?
- Biomarker Stratification by PTX3
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 days
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Previous bariatric surgery
- Severe hepatic, renal, or cardiac failure
- Active infection or inflammatory disease
- Malignancy
About this study
Official title: 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.
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.
- Conditions
- Obesity, Metabolic Syndrome, Insulin Resistance, Inflammation, Roux en Y Gastric Bypass, Chronic Inflammation
- Being tested
- Biomarker Stratification by PTX3
- 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
- Medical subject headings
- Obesity, Metabolic Syndrome, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker Stratification by PTX3Other
Also called Pentraxin-3 (PTX3) Grouping
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Biomarker Stratification by PTX3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (3)
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.
Measured: 6 months
CRP normalization at 6 months
Proportion of patients achieving CRP ≤5 mg/L after surgery. Predictive value of baseline PTX3 will be assessed.
Measured: 6 months
Change in IL-6 from baseline to 6 months
Change in serum IL-6 levels after surgery, analyzed between PTX3 high vs. low groups.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Jan 2015
- Primary completion1 Jul 2015
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Calikoglu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241741
- Sponsor's protocol ID
- ITF_2025_09
- Acronym
- PTX3-BYPASS
- Status last verified
- Nov 2025
- First submitted
- 3 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study team does not plan to share individual participant data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Prospective Study on PTX3 as a Predictor of Insulin Resistance and Inflammatory Resolution After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07241741
- Acronym / sponsor ID
- PTX3-BYPASS / ITF_2025_09
- Conditions
- Obesity, Metabolic Syndrome, Insulin Resistance, Inflammation, Roux en Y Gastric Bypass, Chronic Inflammation
- Keywords
- Pentraxin-3 (PTX3), Insulin Resistance, HOMA-IR, C-Reactive Protein (CRP), Bariatric Surgery, Roux-en-Y Gastric Bypass, Metabolic Outcomes, Inflammatory Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: High PTX3 (≥21.7 ng/mL) | – | Other: Biomarker Stratification by PTX3Participants 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. |
| Group 2: Low PTX3 (<21.7 ng/mL) | – | Other: Biomarker Stratification by PTX3Participants 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. |
Who may qualify
- Ages
- 18 to 65 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Previous bariatric surgery
- Severe hepatic, renal, or cardiac failure
- Active infection or inflammatory disease
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker Stratification by PTX3Also: Pentraxin-3 (PTX3) GroupingParticipants 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 | Group 1: High PTX3 (≥21.7 ng/mL), Group 2: Low PTX3 (<21.7 ng/mL) |
Primary outcome
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.
3 secondary outcomes
Percent Excess Weight Loss (%EWL) at 6 months
Time frame: 6 months
CRP normalization at 6 months
Time frame: 6 months
Change in IL-6 from baseline to 6 months
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No. The study team does not plan to share individual participant data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Metabolic Syndrome, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HOMA-IR from baseline to 6 months (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.