Skip to main content
OpenTrials
Completed

NCT Number: NCT06460233

Blood Pressure Changes After Bariatric Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Pressure Bariatric Surgery Body Weight Cardiovascular Diseases Hypertension Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Warsaw Medical University Teaching Hospital

Warsaw, Masovian Voivodeship, 02-097, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bariatric surgery - sleeve gastrectomy

Procedure

Laparoscopic sleeve gastrectomy performed according to the current surgical standards

Primary outcomes

  1. Change from baseline in the 24-hour blood pressure at one week after bariatric surgery (sleeve gastrectomy)

    Time frame: 1-2 days before and 7 to 10 days after surgery

    Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor

Secondary outcomes

  1. Change from baseline in the 24-hour blood pressure at one month after bariatric surgery (sleeve gastrectomy)

    Time frame: 1-2 days before and 28 to 31 days after surgery

    Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor

  2. Change from baseline in the 24-hour blood pressure at six months after bariatric surgery (sleeve gastrectomy)

    Time frame: 1-2 days before and 5 to 7 months after surgery

    Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor

  3. Change from baseline in the 24-hour blood pressure at one year after bariatric surgery (sleeve gastrectomy)

    Time frame: 1-2 days before and 11 to 13 months after surgery

    Mean systolic and diastolic blood pressure in mmHg measured using 24 hour ambulatory blood pressure monitor

  4. Change from baseline in bedside blood pressure at one week after bariatric surgery

    Time frame: 1-2 days before and 7 to 10 days after 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

  5. Change from baseline in bedside blood pressure at one month after bariatric surgery

    Time frame: 1-2 days before and 28 to 31 days after 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

  6. Change from baseline in bedside blood pressure at six months after bariatric surgery

    Time frame: 1-2 days before and 5 to 7 months after 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

  7. Change from baseline in bedside blood pressure at one year after bariatric surgery

    Time frame: 1-2 days before and 11 to 13 months after 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

  8. Change from baseline in cardiac output at one week after bariatric surgery

    Time frame: 1-2 days before and 7 to 10 days after surgery

    Echocardiographic measurement of cardiac output in liters per minute using Doppler method

  9. Change from baseline in cardiac output at one month after bariatric surgery

    Time frame: 1-2 days before and 28 to 31 days after surgery

    Echocardiographic measurement of cardiac output in liters per minute using Doppler method

  10. Change from baseline in cardiac output at six months after bariatric surgery

    Time frame: 1-2 days before and 5 to 7 months after surgery

    Echocardiographic measurement of cardiac output in liters per minute using Doppler method

  11. Change from baseline in cardiac output at one year after bariatric surgery

    Time frame: 1-2 days before and 11 to 13 months after surgery

    Echocardiographic measurement of cardiac output in liters per minute using Doppler method

  12. Change from baseline in the left ventricular systolic function at one week after bariatric surgery

    Time frame: 1-2 days before and 7 to 10 days after bariatric surgery

    Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method

  13. Change from baseline in the left ventricular systolic function at one month after bariatric surgery

    Time frame: 1-2 days before and 28 to 31 days after bariatric surgery

    Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method

  14. Change from baseline in the left ventricular systolic function at six months after bariatric surgery

    Time frame: 1-2 days before and 5 to 7 months after bariatric surgery

    Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method

  15. Change from baseline in the left ventricular systolic function at one year after bariatric surgery

    Time frame: 1-2 days before and 11 to 13 months after bariatric surgery

    Echocardiographic measurement of the lateral and medial mitral annulus peak systolic velocities in meters per second, using tissue Doppler method

  16. Change from baseline in the left ventricular diastolic function at one week after bariatric surgery

    Time frame: 1-2 days before and 7 to 10 days 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

  17. Change from baseline in the left ventricular diastolic function at one month after bariatric surgery

    Time frame: 1-2 days before and 28 to 31 days 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

  18. Change from baseline in the left ventricular diastolic function at six months after bariatric surgery

    Time frame: 1-2 days before and 5 to 7 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

  19. Change from baseline in the left ventricular diastolic function at one year after bariatric surgery

    Time frame: 1-2 days before and 11 to 13 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

  20. Change from baseline in serum fasting insulin level at one week after bariatric surgery

    Time frame: 1-2 days before and 7 to 10 days after bariatric surgery

    Laboratory measurement of serum fasting insulin level in µIU/ml

  21. Change from baseline in serum fasting insulin level at one month after bariatric surgery

    Time frame: 1-2 days before and 28 to 31 days after bariatric surgery

    Laboratory measurement of serum fasting insulin level in µIU/ml

  22. Change from baseline in serum fasting insulin level at six months after bariatric surgery

    Time frame: 1-2 days before and 5 to 7 months after bariatric surgery

    Laboratory measurement of serum fasting insulin level in µIU/ml

  23. Change from baseline in serum fasting insulin level at one year after bariatric surgery

    Time frame: 1-2 days before and 11 to 13 months after bariatric surgery

    Laboratory measurement of serum fasting insulin level in µIU/ml

  24. Change from baseline in serum high- sensivity C-Reactive Protein level at one week after bariatric surgery

    Time frame: 1-2 days before and 7 to 10 days after bariatric surgery

    Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l

  25. Change from baseline in serum high- sensivity C-Reactive Protein level at one month after bariatric surgery

    Time frame: 1-2 days before and 28 to 31 days after bariatric surgery

    Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l

  26. Change from baseline in serum high- sensivity C-Reactive Protein level at six months after bariatric surgery

    Time frame: 1-2 days before and 5 to 7 months after bariatric surgery

    Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l

  27. Change from baseline in serum high- sensivity C-Reactive Protein level at one year after bariatric surgery

    Time frame: 1-2 days before and 11 to 13 months after bariatric surgery

    Laboratory measurement of serum high- sensivity C-Reactive Protein level in mg/l

  28. Change from baseline in serum Cystatin C level at one week after bariatric surgery

    Time frame: 1-2 days before and 7 to 10 days after bariatric surgery

    Laboratory measurement of serum Cystatin C level in mg/l

  29. Change from baseline in serum Cystatin C level at one month after bariatric surgery

    Time frame: 1-2 days before and 28 to 31 days after bariatric surgery

    Laboratory measurement of serum Cystatin C level in mg/l

  30. Change from baseline in serum Cystatin C level at six months after bariatric surgery

    Time frame: 1-2 days before and 5 to 7 months after bariatric surgery

    Laboratory measurement of serum Cystatin C level in mg/l

  31. Change from baseline in serum Cystatin C level at one year after bariatric surgery

    Time frame: 1-2 days before and 11 to 13 months after bariatric surgery

    Laboratory measurement of serum Cystatin C level in mg/l

  32. Change from baseline in serum NT-proBNP level at one week after bariatric surgery

    Time frame: 1-2 days before and 7 to 10 days after bariatric surgery

    Laboratory measurement of serum NT-proBNP level in pg/ml

  33. Change from baseline in serum NT-proBNP level at one month after bariatric surgery

    Time frame: 1-2 days before and 28 to 31 days after bariatric surgery

    Laboratory measurement of serum NT-proBNP level in pg/ml

  34. Change from baseline in serum NT-proBNP level at six months after bariatric surgery

    Time frame: 1-2 days before and 5 to 7 months after bariatric surgery

    Laboratory measurement of serum NT-proBNP level in pg/ml

  35. Change from baseline in serum NT-proBNP level at one year after bariatric surgery

    Time frame: 1-2 days before and 11 to 13 months after bariatric surgery

    Laboratory measurement of serum NT-proBNP level in pg/ml

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.