How weight-loss surgery changes blood vessel health and inflammation
Effects of Bariatric Surgery on Cardiovascular Risk Profile in Relation to Inflammatory Parameters: Endothelial Phenotyping and Analysis of the Cross-talk Between Adipose Tissue and Endothelium
This project will try to see if weight-loss surgery improves blood vessel function and reduces inflammation in adults with obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Cecilia Hospital Academic / other |
| Locations | 1 site (Cotignola, Ravenna) |
| Trial ID | NCT07131605 on ClinicalTrials.gov |
What this trial studies
Adults with obesity scheduled for mini-gastric bypass or sleeve gastrectomy will be enrolled and have blood, stool, urine samples and cardiology exams collected before surgery and at 6 and 12 months after. Researchers will perform endothelial phenotyping and measure inflammatory markers, adipose-derived factors, and gut-microbiome signals to study how fat tissue communicates with blood vessels. The study tracks changes in vascular function over time as patients lose weight. Results aim to map the timing and mechanisms of vascular recovery after substantial weight loss.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) with BMI ≥30 kg/m² who are scheduled for mini-gastric bypass or sleeve gastrectomy and can attend baseline and 6- and 12-month follow-up visits.
Not a fit: Patients with active systemic inflammatory diseases, acute or chronic infections, severe anemia or coagulation disorders, moderate to severe chronic kidney disease, or active malignancy are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the project could show that bariatric surgery lowers vascular inflammation and cardiovascular risk and identify blood or tissue markers that predict recovery of vessel function.
How similar studies have performed: Previous studies show bariatric surgery improves weight, metabolic health, and some cardiovascular risk markers, but the detailed timing and mechanisms of endothelial recovery and adipose–endothelium cross-talk remain less well defined.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adults (≥ 18 years old); Patients with obesity (Body Mass Index ≥ 30 kg/m²); Patients scheduled to undergo bariatric surgery via mini-gastric bypass or sleeve gastrectomy; Patients able to give their consent and to provide signed and dated informed consent for the processing of personal data; Willingness to attend follow-up visits and undergo all assessments required by the study protocol. Exclusion Criteria: Active systemic inflammatory diseases (e.g., chronic inflammatory bowel diseases, chronic rheumatologic diseases); Acute or chronic infections Severe anemia or coagulation disorders; Moderate to severe chronic kidney disease; Active malignancies.
Where this trial is running
Cotignola, Ravenna
- Maria Cecilia Hospital — Cotignola, Ravenna, Italy (Recruiting)
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.