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

NCT07131605 | Recruiting

• 1 other identifier: BARIHEART
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity (Disorder)

Keywords

obesity; cardiovascular risk

Outcome Measures

Primary Outcomes (2)

• changes at the vascular tissue

  Measurement of circulating endothelial cells ( cells/µL)

  12 months

• To analyze the changes adipose tissue

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

  from enrollment to the end of study at 12 month

Study Arms (1)

Patients who are hospitalized and undergoing either gastric bypass or sleeve gastrectomy surgery

OTHER

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

Interventions

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.

Patients who are hospitalized and undergoing either gastric bypass or sleeve gastrectomy surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Defecation; Urination

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 20, 2025
• Study Start: November 11, 2024
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): November 11, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)