Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-03 @ 2:35 AM
Study NCT ID:
NCT06460233
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2024-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Changes After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006973', 'term': 'Hypertension'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'frozen peripheral blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the 24-hour blood pressure at one week after bariatric surgery (sleeve gastrectomy)', 'timeFrame': '1-2 days before and 7 to 10 days after surgery', 'description': 'Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the 24-hour blood pressure at one month after bariatric surgery (sleeve gastrectomy)', 'timeFrame': '1-2 days before and 28 to 31 days after surgery', 'description': 'Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor'}, {'measure': 'Change from baseline in the 24-hour blood pressure at six months after bariatric surgery (sleeve gastrectomy)', 'timeFrame': '1-2 days before and 5 to 7 months after surgery', 'description': 'Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor'}, {'measure': 'Change from baseline in the 24-hour blood pressure at one year after bariatric surgery (sleeve gastrectomy)', 'timeFrame': '1-2 days before and 11 to 13 months after surgery', 'description': 'Mean systolic and diastolic blood pressure in mmHg measured using 24 hour ambulatory blood pressure monitor'}, {'measure': 'Change from baseline in bedside blood pressure at one week after bariatric surgery', 'timeFrame': '1-2 days before and 7 to 10 days after surgery', 'description': 'Systolic and diastolic blood pressure in mmHg, averaged from two measurements using automatic blood pressure monitor, performed in supine position at the end of echocardiographic study'}, {'measure': 'Change from baseline in bedside blood pressure at one month after bariatric surgery', 'timeFrame': '1-2 days before and 28 to 31 days after surgery', 'description': 'Systolic and diastolic blood pressure in mmHg, averaged from two measurements using automatic blood pressure monitor, performed in supine position at the end of echocardiographic study'}, {'measure': 'Change from baseline in bedside blood pressure at six months after bariatric surgery', 'timeFrame': '1-2 days before and 5 to 7 months after surgery', 'description': 'Systolic and diastolic blood pressure in mmHg, averaged from two measurements using automatic blood pressure monitor, performed in supine position at the end of echocardiographic study'}, {'measure': 'Change from baseline in bedside blood pressure at one year after bariatric surgery', 'timeFrame': '1-2 days before and 11 to 13 months after surgery', 'description': 'Systolic and diastolic blood pressure in mmHg, averaged from two measurements using automatic blood pressure monitor, performed in supine position at the end of echocardiographic study'}, {'measure': 'Change from baseline in cardiac output at one week after bariatric surgery', 'timeFrame': '1-2 days before and 7 to 10 days after surgery', 'description': 'Echocardiographic measurement of cardiac output in liters per minute using Doppler method'}, {'measure': 'Change from baseline in cardiac output at one month after bariatric surgery', 'timeFrame': '1-2 days before and 28 to 31 days after surgery', 'description': 'Echocardiographic measurement of cardiac output in liters per minute using Doppler method'}, {'measure': 'Change from baseline in cardiac output at six months after bariatric surgery', 'timeFrame': '1-2 days before and 5 to 7 months after surgery', 'description': 'Echocardiographic measurement of cardiac output in liters per minute using Doppler method'}, {'measure': 'Change from baseline in cardiac output at one year after bariatric surgery', 'timeFrame': '1-2 days before and 11 to 13 months after surgery', 'description': 'Echocardiographic measurement of cardiac output in liters per minute using Doppler method'}, {'measure': 'Change from baseline in the left ventricular systolic function at one week after bariatric surgery', 'timeFrame': '1-2 days before and 7 to 10 days after bariatric surgery', 'description': 'Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method'}, {'measure': 'Change from baseline in the left ventricular systolic function at one month after bariatric surgery', 'timeFrame': '1-2 days before and 28 to 31 days after bariatric surgery', 'description': 'Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method'}, {'measure': 'Change from baseline in the left ventricular systolic function at six months after bariatric surgery', 'timeFrame': '1-2 days before and 5 to 7 months after bariatric surgery', 'description': 'Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method'}, {'measure': 'Change from baseline in the left ventricular systolic function at one year after bariatric surgery', 'timeFrame': '1-2 days before and 11 to 13 months after bariatric surgery', 'description': 'Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method'}, {'measure': 'Change from baseline in the left ventricular diastolic function at one week after bariatric surgery', 'timeFrame': '1-2 days before and 7 to 10 days after bariatric surgery', 'description': 'Echocardiographic measurement of the lateral and medial mitral annulus peak early diastolic velocities in meters per second, using tissue Doppler method, and of the early and late mitral inflow peak velocities in meters per second, using pulse wave Doppler method'}, {'measure': 'Change from baseline in the left ventricular diastolic function at one month after bariatric surgery', 'timeFrame': '1-2 days before and 28 to 31 days after bariatric surgery', 'description': 'Echocardiographic measurement of the lateral and medial mitral annulus peak early diastolic velocities in meters per second, using tissue Doppler method, and of the early and late mitral inflow peak velocities in meters per second, using pulse wave Doppler method'}, {'measure': 'Change from baseline in the left ventricular diastolic function at six months after bariatric surgery', 'timeFrame': '1-2 days before and 5 to 7 months after bariatric surgery', 'description': 'Echocardiographic measurement of the lateral and medial mitral annulus peak early diastolic velocities in meters per second, using tissue Doppler method, and of the early and late mitral inflow peak velocities in meters per second, using pulse wave Doppler method'}, {'measure': 'Change from baseline in the left ventricular diastolic function at one year after bariatric surgery', 'timeFrame': '1-2 days before and 11 to 13 months after bariatric surgery', 'description': 'Echocardiographic measurement of the lateral and medial mitral annulus peak early diastolic velocities in meters per second, using tissue Doppler method, and of the early and late mitral inflow peak velocities in meters per second, using pulse wave Doppler method'}, {'measure': 'Change from baseline in serum fasting insulin level at one week after bariatric surgery', 'timeFrame': '1-2 days before and 7 to 10 days after bariatric surgery', 'description': 'Laboratory measurement of serum fasting insulin level in µIU/ml'}, {'measure': 'Change from baseline in serum fasting insulin level at one month after bariatric surgery', 'timeFrame': '1-2 days before and 28 to 31 days after bariatric surgery', 'description': 'Laboratory measurement of serum fasting insulin level in µIU/ml'}, {'measure': 'Change from baseline in serum fasting insulin level at six months after bariatric surgery', 'timeFrame': '1-2 days before and 5 to 7 months after bariatric surgery', 'description': 'Laboratory measurement of serum fasting insulin level in µIU/ml'}, {'measure': 'Change from baseline in serum fasting insulin level at one year after bariatric surgery', 'timeFrame': '1-2 days before and 11 to 13 months after bariatric surgery', 'description': 'Laboratory measurement of serum fasting insulin level in µIU/ml'}, {'measure': 'Change from baseline in serum high- sensivity C-Reactive Protein level at one week after bariatric surgery', 'timeFrame': '1-2 days before and 7 to 10 days after bariatric surgery', 'description': 'Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l'}, {'measure': 'Change from baseline in serum high- sensivity C-Reactive Protein level at one month after bariatric surgery', 'timeFrame': '1-2 days before and 28 to 31 days after bariatric surgery', 'description': 'Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l'}, {'measure': 'Change from baseline in serum high- sensivity C-Reactive Protein level at six months after bariatric surgery', 'timeFrame': '1-2 days before and 5 to 7 months after bariatric surgery', 'description': 'Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l'}, {'measure': 'Change from baseline in serum high- sensivity C-Reactive Protein level at one year after bariatric surgery', 'timeFrame': '1-2 days before and 11 to 13 months after bariatric surgery', 'description': 'Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l'}, {'measure': 'Change from baseline in serum Cystatin C level at one week after bariatric surgery', 'timeFrame': '1-2 days before and 7 to 10 days after bariatric surgery', 'description': 'Laboratory measurement of serum Cystatin C level in mg/l'}, {'measure': 'Change from baseline in serum Cystatin C level at one month after bariatric surgery', 'timeFrame': '1-2 days before and 28 to 31 days after bariatric surgery', 'description': 'Laboratory measurement of serum Cystatin C level in mg/l'}, {'measure': 'Change from baseline in serum Cystatin C level at six months after bariatric surgery', 'timeFrame': '1-2 days before and 5 to 7 months after bariatric surgery', 'description': 'Laboratory measurement of serum Cystatin C level in mg/l'}, {'measure': 'Change from baseline in serum Cystatin C level at one year after bariatric surgery', 'timeFrame': '1-2 days before and 11 to 13 months after bariatric surgery', 'description': 'Laboratory measurement of serum Cystatin C level in mg/l'}, {'measure': 'Change from baseline in serum NT-proBNP level at one week after bariatric surgery', 'timeFrame': '1-2 days before and 7 to 10 days after bariatric surgery', 'description': 'Laboratory measurement of serum NT-proBNP level in pg/ml'}, {'measure': 'Change from baseline in serum NT-proBNP level at one month after bariatric surgery', 'timeFrame': '1-2 days before and 28 to 31 days after bariatric surgery', 'description': 'Laboratory measurement of serum NT-proBNP level in pg/ml'}, {'measure': 'Change from baseline in serum NT-proBNP level at six months after bariatric surgery', 'timeFrame': '1-2 days before and 5 to 7 months after bariatric surgery', 'description': 'Laboratory measurement of serum NT-proBNP level in pg/ml'}, {'measure': 'Change from baseline in serum NT-proBNP level at one year after bariatric surgery', 'timeFrame': '1-2 days before and 11 to 13 months after bariatric surgery', 'description': 'Laboratory measurement of serum NT-proBNP level in pg/ml'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Obesity', 'Bariatric surgery'], 'conditions': ['Blood Pressure', 'Obesity', 'Bariatric Surgery', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess changes in blood pressure, cardiac function and selected laboratory measurements after bariatric surgery and to find most important factors associated with blood pressure reduction after weight loss.\n\nDescription of the study\n\nPatients: consecutive patients with class III obesity (BMI ≥ 40kg/m2) or class II obesity (BMI 35-40kg/m2) with comorbidities, admitted for sleeve gastrectomy\n\nMethods: bedside and 24-hour blood pressure measurement, cardiac ultrasound and laboratory tests performed before surgery and at 1 week, 4 weeks, 6 months and 12 months after bariatric surgery', 'detailedDescription': 'Pathogenesis of blood pressure reduction associated with weight loss is not established. We hypothesize that monitoring of blood pressure changes after weight loss, with concomitant evaluation of cardiac output and selected biochemical parameters related to blood pressure regulation may help in the understanding of weight loss-associated decrease in blood pressure.\n\nThe study protocol include measurement of blood pressure (bedside and 24h blood pressure monitoring), assessment of the cardiac function and biochemistry 1-2 days before laparoscopic sleeve gastrectomy and at the time of routine surgical follow-up visits after surgery ie. one week, one month, six and twelve months. Blood pressure measurements will be performed using automatic oscillometric monitors (OnTrak , Spacelabs,USA). Cardiac evaluation will include an echocardiographic assessment of the systolic and diastolic left ventricular function as well as cardiac output measurement using Doppler method. Biochemistry measures, in addition to routine blood tests needed for surgical follow-up, will include fasting insulin, high sensivity C-reactive protein, cystatin C, and NT-proBNP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study includes all consecutive patients with class III obesity or class II obesity with comorbidities, admitted for bariatric surgery (sleeve gastrectomy) to the Departement of General, Transplant and Liver Surgery, Medical University of Warsaw', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥40kg/m2 or ≥35 kg/m2 with comorbidities\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Expected lack of compliance\n* Psychiatric illness\n* Previous bariatric surgery\n* Severe gastroesophageal reflux disease\n* Active neoplastic disease\n* Pregnancy\n* Chronic atrial fibrillation or other persistent arrhythmia'}, 'identificationModule': {'nctId': 'NCT06460233', 'briefTitle': 'Blood Pressure Changes After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Dynamics of Blood Pressure Changes After Bariatric Surgery, Assessed With 24-h Blood Pressure Monitoring', 'orgStudyIdInfo': {'id': 'KB/173/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with class III obesity (BMI ≥ 40) or class II obesity (BMI 35-40) with comorbidities', 'description': 'Consecutive patients with class III obesity (BMI ≥ 40kg/m2) or class II obesity (BMI 35-40kg/m2) with comorbidities admitted for bariatric surgery (sleeve gastrectomy)', 'interventionNames': ['Procedure: Bariatric surgery - sleeve gastrectomy']}], 'interventions': [{'name': 'Bariatric surgery - sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic sleeve gastrectomy performed according to the current surgical standards', 'armGroupLabels': ['Patients with class III obesity (BMI ≥ 40) or class II obesity (BMI 35-40) with comorbidities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-097', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Central Warsaw Medical University Teaching Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Grzegorz Styczynski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'timeFrame': 'between 3 months and 5 years after the end of the study', 'ipdSharing': 'YES', 'description': "All anonymized patient's data collected during the study will be shared with other researchers who provide methodologically sound proposal", 'accessCriteria': 'e-mail contact with the principal investigator: grzegorz.styczynski@wum.edu.pl'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Grzegorz Styczyński', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}