Examining lipid, immune, and miRNA changes in obese patients undergoing diet or bariatric surgery
Official title: Changes in the Lipidomic, Immunological and Circulating microRNA Profile in Patients With Hepatobiliary Pathology, Suffering From Morbid Obesity Undergoing a Dietary Program or Bariatric Surgery
Run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · NCT06372015 · Data updated 2026-11-12
This study looks at how diet changes or weight-loss surgery affect fat levels, immune responses, and certain molecules in obese patients with liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, Bari) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | June 1, 2025 |
| Study ends | June 1, 2026 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT06372015 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are obese adults over 18 years old with a BMI greater than 30 kg/m2 and diagnosed with hepato-biliary pathology.
✕Probably not a fit
Patients who are not obese or do not have hepato-biliary pathology will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the changes in lipidomic, immunological, and miRNA profiles in obese patients with liver disease who are undergoing either a dietary program or bariatric surgery. The study aims to understand how these interventions affect the patients' metabolic and immune responses. Participants will be monitored by a multidisciplinary team to ensure comprehensive care throughout the treatment process. The research focuses on patients with a BMI greater than 30 kg/m2 and diagnosed hepato-biliary pathology.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for obesity and associated liver diseases, enhancing patient outcomes.
How similar studies have gone: Other studies have shown promising results in understanding metabolic changes following bariatric surgery, indicating that this approach is supported by existing research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Obese patients (BMI \>30kg/m2) suffering from hepato-biliary pathology diagnosed by Fibroscan * Adult patients (\>18 years). Exclusion Criteria: * Patients who are not obese or not affected by hepato-biliary pathology
Where it's running
-
IRCCS "Saverio de Bellis"
Castellana Grotte, Bari, Italy Recruiting
Study contacts
- Principal investigator: Rossella Donghia, Biologyst — Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Study coordinator: Rossella Donghia, Biologyst
- Email: rossella.donghia@irccsdebellis.it
- Phone: 0804994652
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.