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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaria Cecilia Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: Patients who are hospitalized and undergoing either gastric bypass or sleeve gastrectomy surgeryOther 1 intervention

Trial outcomes

Primary outcomes

1

changes at the vascular tissue

Measurement of circulating endothelial cells ( cells/µL)

Time frame
12 months
2

To analyze the changes adipose tissue

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

Time frame
from enrollment to the end of study at 12 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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