Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-02 @ 11:55 AM
Study NCT ID:
NCT07131605
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003672', 'term': 'Defecation'}, {'id': 'D014554', 'term': 'Urination'}], 'ancestors': [{'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes at the vascular tissue', 'timeFrame': '12 months', 'description': 'Measurement of circulating endothelial cells ( cells/µL)'}, {'measure': 'To analyze the changes adipose tissue', 'timeFrame': 'from enrollment to the end of study at 12 month', 'description': 'Cardiac CT for assessment of epicardial adipose tissue. Volume quantification by tracing (cm³)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity Cardiovascular risk, Metabolic impact, Bariatric surgery'], 'conditions': ['Obesity (Disorder)']}, 'descriptionModule': {'briefSummary': '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.\n\nOur 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.', 'detailedDescription': '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.\n\nEndothelial 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.\n\nBariatric 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.\n\nSpecifically, 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.\n\nOur 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults (≥ 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.\n\nExclusion Criteria:\n\nActive 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.'}, 'identificationModule': {'nctId': 'NCT07131605', 'acronym': 'BARIHEART', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Maria Cecilia Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BARIHEART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients who are hospitalized and undergoing either gastric bypass or sleeve gastrectomy surgery', 'interventionNames': ['Other: Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examination']}], 'interventions': [{'name': 'Before bariatric surgery, both blood and biological samples (stool and urine) will be collected. Patients will also undergo a cardiology examination', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Patients who are hospitalized and undergoing either gastric bypass or sleeve gastrectomy surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48033', 'city': 'Cotignola', 'state': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elena Tenti', 'role': 'CONTACT', 'email': 'etenti@gvmnet.it', 'phone': '+39 0545217031'}, {'name': 'Margherita Tiezzi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be publicly shared. However, de-identified data may be made available to qualified researchers upon reasonable request to the study center and the Principal Investigator. All data will be processed in compliance with the General Data Protection Regulation (GDPR - EU Regulation 2016/679), ensuring the confidentiality, integrity, and protection of participants\' personal information."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Cecilia Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}