Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-06 @ 5:29 PM
Study NCT ID:
NCT03115502
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2016-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2016-01-13', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean changes 24h-aortic systolic-blood pressure (SBP) measured in mmHg', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.'}], 'secondaryOutcomes': [{'measure': 'Mean changes in aortic- 24h, daytime and nighttime blood pressure estimates others than 24h systolic blood pressure measured in mmHg', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.'}, {'measure': 'Mean changes in peripheral- 24h, daytime and nighttime blood pressure estimates measured in mmHg', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.'}, {'measure': 'Mean change in office blood pressure estimates measured in mmHg', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.'}, {'measure': 'Mean change in arterial stiffness parameters (I)', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'pulse wave velocity measured in m/s'}, {'measure': 'Mean change in arterial stiffness parameters (II)', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'augmentation index measured in %'}, {'measure': 'Mean change in Left ventricular mass index', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'Left ventricular mass index measured in g/m2'}, {'measure': 'Mean change in Left atrium diameter', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'Left atrium diameter measured in mm'}, {'measure': 'Mean change in Ejection fraction', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'Ejection fraction measured in %,'}, {'measure': 'Mean change in left ventricular remodeling index', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'left ventricular remodeling index, do not have units'}, {'measure': 'Mean change in carotid intima-media thickness measured in mm', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.'}, {'measure': 'Mean change in biochemical parameters measured in mg/dl or mmol/L', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.'}, {'measure': 'Mean change in the components of the renin-angiotensin system', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'renin-angiotensin system: plasma renin activity: ng/mL/h, plasma aldosterone: pg/ml, angiotensinogen: mng/100ml, angiotensin 1-7: pg/ml, ACE: UI/l, ACE-2: UI/I'}, {'measure': 'Mean change in the serotonergic system components', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'serotonergic system: 5-HIAA:ng/ml, 5-HT:ng/mL'}, {'measure': 'Mean change in the components of the endocannabinoid system', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'endocannabinoid system: Anandamide: nmol/mL, 2-arachidonoylglycerol: mg/ml'}, {'measure': 'Mean change in pro-atherosclerotic markers', 'timeFrame': 'From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.', 'description': 'pro-atherosclerotic markers: omentine-1: ng/ml, chemerine: ng/ml, leptin: ng/ml, adiponectine: mcg/ml'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Systemic Vascular Resistance']}, 'referencesModule': {'references': [{'pmid': '33331692', 'type': 'DERIVED', 'citation': 'Oliveras A, Molina L, Goday A, Sans L, Riera M, Vazquez S, Benaiges D, Granados AM, Ramon JM, Pascual J. Effect of bariatric surgery on cardiac structure and function in obese patients: Role of the renin-angiotensin system. J Clin Hypertens (Greenwich). 2021 Jan;23(1):181-192. doi: 10.1111/jch.14129. Epub 2020 Dec 17.'}, {'pmid': '31346932', 'type': 'DERIVED', 'citation': 'Oliveras A, Goday A, Sans L, Arias CE, Vazquez S, Benaiges D, Ramon JM, Pascual J. Changes in Central 24-h Ambulatory Blood Pressure and Hemodynamics 12 Months After Bariatric Surgery: the BARIHTA Study. Obes Surg. 2020 Jan;30(1):195-205. doi: 10.1007/s11695-019-04107-9.'}]}, 'descriptionModule': {'briefSummary': 'Obese patients have increased cardiovascular risk and target organ damage (TOD) as compared to people with normal weight. Weight loss reduces cardiovascular risk and TOD. These changes have been associated mainly to changes in inflammatory and pro-atherogenic markers. Office peripheral blood pressure (BP) appears to decrease after bariatric surgery, but information on changes in 24h-ambulatory-BP-monitoring (24h-ABPM) and central-BP(cBP), or about the possible role of renin-angiotensin-aldosterone (RAAS), serotonin(STS) and endocannabinoid(ECS) systems is scarce. Our hypothesis is that the hemodynamic changes mediated by alterations in the RAAS, STS and ECS after weight loss are also responsible for the reduction of TOD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 - 65 years, who have medical indication for treatment with bariatric surgery and agreeing to undergo the intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 - 65 years,\n2. who have medical indication for treatment with bariatric surgery and agreeing to undergo the intervention,with\n3. given informed consent\n\nExclusion Criteria:\n\n1\\. Unmeeting the above Inclusion Criteria.'}, 'identificationModule': {'nctId': 'NCT03115502', 'briefTitle': 'Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery. Prognostic Value Regarding Hypertension and Target Organ Damage', 'orgStudyIdInfo': {'id': 'Baritha'}}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar_Nefrology', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Hypertension & Vascular Risk Unit. Nephrology Department', 'investigatorFullName': 'Anna Oliveras', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}