Blood Pressure Changes After Bariatric Surgery
NCT Number: NCT06460233
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Pressure|Obesity|Bariatric Surgery|Hypertension
Interventions: PROCEDURE: Bariatric surgery - sleeve gastrectomy
Sponsor: Medical University of Warsaw
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-09-21
Completion Date: 2026-06-15
Locations: Central Warsaw Medical University Teaching Hospital, Warsaw, Mazowieckie, 02-097, Poland

Summary:
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.

Description of the study

Patients: consecutive patients with class III obesity (BMI ≥ 40kg/m2) or class II obesity (BMI 35-40kg/m2) with comorbidities, admitted for sleeve gastrectomy

Methods: 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

Primary Outcome Measures: Change from baseline in the 24-hour blood pressure at one week after bariatric surgery (sleeve gastrectomy), Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor, 1-2 days before and 7 to 10 days after surgery
Secondary Outcome Measures: Change from baseline in the 24-hour blood pressure at one month after bariatric surgery (sleeve gastrectomy), Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor, 1-2 days before and 28 to 31 days after surgery|Change from baseline in the 24-hour blood pressure at six months after bariatric surgery (sleeve gastrectomy), Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor, 1-2 days before and 5 to 7 months after surgery|Change from baseline in the 24-hour blood pressure at one year after bariatric surgery (sleeve gastrectomy), Mean systolic and diastolic blood pressure in mmHg measured using 24 hour ambulatory blood pressure monitor, 1-2 days before and 11 to 13 months after surgery|Change from baseline in bedside blood pressure at one week after bariatric surgery, 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, 1-2 days before and 7 to 10 days after surgery|Change from baseline in bedside blood pressure at one month after bariatric surgery, 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, 1-2 days before and 28 to 31 days after surgery|Change from baseline in bedside blood pressure at six months after bariatric surgery, 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, 1-2 days before and 5 to 7 months after surgery|Change from baseline in bedside blood pressure at one year after bariatric surgery, 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, 1-2 days before and 11 to 13 months after surgery|Change from baseline in cardiac output at one week after bariatric surgery, Echocardiographic measurement of cardiac output in liters per minute using Doppler method, 1-2 days before and 7 to 10 days after surgery|Change from baseline in cardiac output at one month after bariatric surgery, Echocardiographic measurement of cardiac output in liters per minute using Doppler method, 1-2 days before and 28 to 31 days after surgery|Change from baseline in cardiac output at six months after bariatric surgery, Echocardiographic measurement of cardiac output in liters per minute using Doppler method, 1-2 days before and 5 to 7 months after surgery|Change from baseline in cardiac output at one year after bariatric surgery, Echocardiographic measurement of cardiac output in liters per minute using Doppler method, 1-2 days before and 11 to 13 months after surgery|Change from baseline in the left ventricular systolic function at one week after bariatric surgery, Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method, 1-2 days before and 7 to 10 days after bariatric surgery|Change from baseline in the left ventricular systolic function at one month after bariatric surgery, Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method, 1-2 days before and 28 to 31 days after bariatric surgery|Change from baseline in the left ventricular systolic function at six months after bariatric surgery, Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method, 1-2 days before and 5 to 7 months after bariatric surgery|Change from baseline in the left ventricular systolic function at one year after bariatric surgery, Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method, 1-2 days before and 11 to 13 months after bariatric surgery|Change from baseline in the left ventricular diastolic function at one week after bariatric surgery, 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, 1-2 days before and 7 to 10 days after bariatric surgery|Change from baseline in the left ventricular diastolic function at one month after bariatric surgery, 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, 1-2 days before and 28 to 31 days after bariatric surgery|Change from baseline in the left ventricular diastolic function at six months after bariatric surgery, 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, 1-2 days before and 5 to 7 months after bariatric surgery|Change from baseline in the left ventricular diastolic function at one year after bariatric surgery, 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, 1-2 days before and 11 to 13 months after bariatric surgery|Change from baseline in serum fasting insulin level at one week after bariatric surgery, Laboratory measurement of serum fasting insulin level in µIU/ml, 1-2 days before and 7 to 10 days after bariatric surgery|Change from baseline in serum fasting insulin level at one month after bariatric surgery, Laboratory measurement of serum fasting insulin level in µIU/ml, 1-2 days before and 28 to 31 days after bariatric surgery|Change from baseline in serum fasting insulin level at six months after bariatric surgery, Laboratory measurement of serum fasting insulin level in µIU/ml, 1-2 days before and 5 to 7 months after bariatric surgery|Change from baseline in serum fasting insulin level at one year after bariatric surgery, Laboratory measurement of serum fasting insulin level in µIU/ml, 1-2 days before and 11 to 13 months after bariatric surgery|Change from baseline in serum high- sensivity C-Reactive Protein level at one week after bariatric surgery, Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l, 1-2 days before and 7 to 10 days after bariatric surgery|Change from baseline in serum high- sensivity C-Reactive Protein level at one month after bariatric surgery, Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l, 1-2 days before and 28 to 31 days after bariatric surgery|Change from baseline in serum high- sensivity C-Reactive Protein level at six months after bariatric surgery, Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l, 1-2 days before and 5 to 7 months after bariatric surgery|Change from baseline in serum high- sensivity C-Reactive Protein level at one year after bariatric surgery, Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l, 1-2 days before and 11 to 13 months after bariatric surgery|Change from baseline in serum Cystatin C level at one week after bariatric surgery, Laboratory measurement of serum Cystatin C level in mg/l, 1-2 days before and 7 to 10 days after bariatric surgery|Change from baseline in serum Cystatin C level at one month after bariatric surgery, Laboratory measurement of serum Cystatin C level in mg/l, 1-2 days before and 28 to 31 days after bariatric surgery|Change from baseline in serum Cystatin C level at six months after bariatric surgery, Laboratory measurement of serum Cystatin C level in mg/l, 1-2 days before and 5 to 7 months after bariatric surgery|Change from baseline in serum Cystatin C level at one year after bariatric surgery, Laboratory measurement of serum Cystatin C level in mg/l, 1-2 days before and 11 to 13 months after bariatric surgery|Change from baseline in serum NT-proBNP level at one week after bariatric surgery, Laboratory measurement of serum NT-proBNP level in pg/ml, 1-2 days before and 7 to 10 days after bariatric surgery|Change from baseline in serum NT-proBNP level at one month after bariatric surgery, Laboratory measurement of serum NT-proBNP level in pg/ml, 1-2 days before and 28 to 31 days after bariatric surgery|Change from baseline in serum NT-proBNP level at six months after bariatric surgery, Laboratory measurement of serum NT-proBNP level in pg/ml, 1-2 days before and 5 to 7 months after bariatric surgery|Change from baseline in serum NT-proBNP level at one year after bariatric surgery, Laboratory measurement of serum NT-proBNP level in pg/ml, 1-2 days before and 11 to 13 months after bariatric surgery