Obesity (Disorder)BARIHEARTNCT07131605
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
A study testing Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examination in people with Obesity (Disorder), run by Maria Cecilia Hospital at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2024to 11 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Maria Cecilia Hospital
Cotignola, Ravenna, 48033
Elena Tenti, +39 0545217031, etenti@gvmnet.it
Margherita Tiezzi
About this study
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.
Read the detailed description
The pathogenesis of obesity is multifactorial, involving dietary, socioeconomic, genetic, and metabolic factors. The accumulation of adipose tissue-especially abdominal fat-is only one aspect of the disease. Visceral fat, in fact, produces pro-inflammatory cytokines (adipocytokines) that contribute to the local recruitment of activated inflammatory macrophages (known as M1). These cells progressively accumulate in the adipose tissue and further amplify the inflammatory response.
Endothelial dysfunction, defined as the inability of the endothelium to regulate key vascular functions (such as vasodilation, coagulation, and permeability), is considered the earliest pathological event leading to atherosclerosis. In obesity, systemic inflammation, adipose tissue dysfunction, oxidative stress, and the presence of other risk factors contribute to impaired endothelial homeostasis-events that occur well before clinically evident cardiovascular (CV) disease.
Bariatric surgery has proven effective not only in reducing body weight but also in improving obesity-related comorbidities, particularly those involving the cardiovascular system. The hypothesis that weight loss also restores endothelial homeostasis-by interrupting the positive inflammatory feedback loop driven by fat accumulation-is supported by recent literature. However, the timing of functional recovery, as well as the influence of individual differences and cardiovascular risk factors on this process, remains unclear. Moreover, the mechanisms underlying adipose tissue-endothelium interactions are still only partially understood.This experimental project aims to study the cardiovascular and metabolic impact of obesity, and how this changes in response to the drastic weight loss induced by bariatric surgery.
Specifically, we plan to analyze endothelial homeostasis and adipose tissue dysfunction in these patients, in order to detect subclinical vascular alterations and explore potential mechanisms of cross-talk between adipocytes and the endothelium.
Our central hypothesis is that obesity leads to altered endothelial homeostasis, driven by mediators released from adipose tissue and by changes in the gut microbiota. We expect that, at 6 and 12 months after surgery-and with adequate weight loss-there will be progressive resolution of endothelial dysfunction, along with a reduction in circulating adipose-specific mediators and inflammatory markers, ultimately leading to a significant improvement in overall cardiovascular risk profile.
- Conditions
- Obesity (Disorder)
- Being tested
- Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examination
- Keywords
- obesity, cardiovascular risk
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who are hospitalized and undergoing either gastric bypass or sleeve gastrectomy surgery | Other | Not described Receives: Other: Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes at the vascular tissue
Measurement of circulating endothelial cells ( cells/µL)
Measured: 12 months
To analyze the changes adipose tissue
Cardiac CT for assessment of epicardial adipose tissue. Volume quantification by tracing (cm³)
Measured: from enrollment to the end of study at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start11 Nov 2024
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131605
- Sponsor's protocol ID
- BARIHEART
- Acronym
- BARIHEART
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07131605
- Acronym / sponsor ID
- BARIHEART / BARIHEART
- Conditions
- Obesity (Disorder)
- Keywords
- obesity, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The pathogenesis of obesity is multifactorial, involving dietary, socioeconomic, genetic, and metabolic factors. The accumulation of adipose tissue-especially abdominal fat-is only one aspect of the disease. Visceral fat, in fact, produces pro-inflammatory cytokines (adipocytokines) that contribute to the local recruitment of activated inflammatory macrophages (known as M1). These cells progressively accumulate in the adipose tissue and further amplify the inflammatory response.
Endothelial dysfunction, defined as the inability of the endothelium to regulate key vascular functions (such as vasodilation, coagulation, and permeability), is considered the earliest pathological event leading to atherosclerosis. In obesity, systemic inflammation, adipose tissue dysfunction, oxidative stress, and the presence of other risk factors contribute to impaired endothelial homeostasis-events that occur well before clinically evident cardiovascular (CV) disease.
Bariatric surgery has proven effective not only in reducing body weight but also in improving obesity-related comorbidities, particularly those involving the cardiovascular system. The hypothesis that weight loss also restores endothelial homeostasis-by interrupting the positive inflammatory feedback loop driven by fat accumulation-is supported by recent literature. However, the timing of functional recovery, as well as the influence of individual differences and cardiovascular risk factors on this process, remains unclear. Moreover, the mechanisms underlying adipose tissue-endothelium interactions are still only partially understood.This experimental project aims to study the cardiovascular and metabolic impact of obesity, and how this changes in response to the drastic weight loss induced by bariatric surgery.
Specifically, we plan to analyze endothelial homeostasis and adipose tissue dysfunction in these patients, in order to detect subclinical vascular alterations and explore potential mechanisms of cross-talk between adipocytes and the endothelium.
Our central hypothesis is that obesity leads to altered endothelial homeostasis, driven by mediators released from adipose tissue and by changes in the gut microbiota. We expect that, at 6 and 12 months after surgery-and with adequate weight loss-there will be progressive resolution of endothelial dysfunction, along with a reduction in circulating adipose-specific mediators and inflammatory markers, ultimately leading to a significant improvement in overall cardiovascular risk profile.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examinationThis 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. | Other | Patients who are hospitalized and undergoing either gastric bypass or sleeve gastrectomy surgery |
Primary outcome
changes at the vascular tissue
Time frame: 12 months
Measurement of circulating endothelial cells ( cells/µL)
To analyze the changes adipose tissue
Time frame: from enrollment to the end of study at 12 month
Cardiac CT for assessment of epicardial adipose tissue. Volume quantification by tracing (cm³)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examination in people with Obesity (Disorder), run by Maria Cecilia Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes at the vascular tissue (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.