Blood Pressure Changes After Bariatric Surgery

Obesity Clinical Trial

Official title:

Dynamics of Blood Pressure Changes After Bariatric Surgery, Assessed With 24-h Blood Pressure Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460233
• Other study ID #: KB/173/2020
• Status: Recruiting
• Start date: September 21, 2021
• Est. completion date: June 15, 2026

Study information

• Verified date: June 2024
• Source: Medical University of Warsaw
• Contact: Grzegorz Styczynski, MD, PhD
• Phone: 48 502851288
• Email: grzegorz.styczynski[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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.

The 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• BMI =40kg/m2 or =35 kg/m2 with comorbidities

Exclusion Criteria:

• Lack of informed consent

• Expected lack of compliance

• Psychiatric illness

• Previous bariatric surgery

• Severe gastroesophageal reflux disease

• Active neoplastic disease

• Pregnancy

• Chronic atrial fibrillation or other persistent arrhythmia

Related Conditions & MeSH terms

• Bariatric Surgery
• Blood Pressure
• Hypertension
• Obesity

Intervention

Procedure:
• Bariatric surgery - sleeve gastrectomy
Laparoscopic sleeve gastrectomy performed according to the current surgical standards

Locations

Country	Name	City	State
Poland	Central Warsaw Medical University Teaching Hospital	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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