Examining lipid, immune, and miRNA changes in obese patients undergoing diet or bariatric surgery
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
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, Bari) |
| Trial ID | NCT06372015 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are not obese or do not have hepato-biliary pathology will not benefit from this study.
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 performed: Other studies have shown promising results in understanding metabolic changes following bariatric surgery, indicating that this approach is supported by existing research.
Eligibility criteria
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 this trial is running
Castellana Grotte, Bari
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.