Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07131605

Recruiting nowNot applicableInterventional

What this study is about

This research project aims to study how obesity affects the heart and metabolism, and how these effects change after significant weight loss following bariatric surgery. In particular, we want to look at how blood vessels and fat tissue function in people with obesity, to detect early signs of vascular problems and understand how fat tissue communicates with blood vessels. Our main idea is that obesity disrupts the normal function of blood vessels, partly due to substances released by fat tissue and changes in gut bacteria. We believe that 6 and 12 months after surgery - with proper weight loss - these problems will gradually improve. We expect to see better blood vessel function and lower levels of inflammation and fat-related substances in the blood, which could significantly reduce the overall risk of heart disease.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity (Disorder)

Full registry 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.

Treatments and study arms

Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examination

Other

This study includes a comprehensive set of laboratory and clinical investigations to evaluate the cardiovascular and metabolic impact of obesity and its modulation after bariatric surgery. Multiple biological samples (blood, urine, stool, and omental adipose tissue) will be collected at baseline and during follow-up.

Primary outcomes

changes at the vascular tissue12 months

Measurement of circulating endothelial cells ( cells/µL)

To analyze the changes adipose tissuefrom enrollment to the end of study at 12 month

Cardiac CT for assessment of epicardial adipose tissue. Volume quantification by tracing (cm³)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Maria Cecilia Hospital🇮🇹 Cotignola, Ravenna, Italy

Open map

Elena TentiContact

Email · Call +39 0545217031

Margherita TiezziPrincipal Investigator