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AzTrials

Blood PressureNCT06460233

Blood Pressure Changes After Bariatric Surgery

An observational study of Blood Pressure and Obesity, run by Medical University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Blood Pressure, Obesity, Bariatric Surgery
What is being tested?
Bariatric surgery - sleeve gastrectomy
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 sitePoland
Study dates
21 Sep 2021to 15 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Central Warsaw Medical University Teaching Hospital

    Warsaw, Masovian Voivodeship, 02-097

Other trials in Poland

About this study

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

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

Read the detailed 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.

Being tested
Bariatric surgery - sleeve gastrectomy
Keywords
Hypertension, Obesity, Bariatric surgery
Medical subject headings
Obesity, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bariatric surgery - sleeve gastrectomyProcedure or surgery

    Laparoscopic sleeve gastrectomy performed according to the current surgical standards

Study groups in NCT06460233
Study groupRoleWhat they receive
Patients with class III obesity (BMI ≥ 40) or class II obesity (BMI 35-40) with comorbiditiesConsecutive patients with class III obesity (BMI ≥ 40kg/m2) or class II obesity (BMI 35-40kg/m2) with comorbidities admitted for bariatric surgery (sleeve gastrectomy)
Receives: Procedure: Bariatric surgery - sleeve gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (35)
  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

  6. 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

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

  7. 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

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

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

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

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

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

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

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

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

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

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

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

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

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

  12. 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

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

  13. 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

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

  14. 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

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

  15. 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

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

  16. 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

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

  17. 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

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

  18. 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

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

  19. 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

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

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

    Laboratory measurement of serum fasting insulin level in µIU/ml

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

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

    Laboratory measurement of serum fasting insulin level in µIU/ml

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

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

    Laboratory measurement of serum fasting insulin level in µIU/ml

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

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

    Laboratory measurement of serum fasting insulin level in µIU/ml

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

  24. 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

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

  25. 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

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

  26. 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

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

  27. 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

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

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

    Laboratory measurement of serum Cystatin C level in mg/l

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

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

    Laboratory measurement of serum Cystatin C level in mg/l

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

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

    Laboratory measurement of serum Cystatin C level in mg/l

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

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

    Laboratory measurement of serum Cystatin C level in mg/l

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

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

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

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

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

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

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

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2024
  2. Study start21 Sep 2021
  3. Primary completion15 Jun 2025
  4. Study completion15 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06460233
Sponsor's protocol ID
KB/173/2020
Status last verified
Jul 2025
First submitted
24 May 2024
Last updated
18 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All anonymized patient's data collected during the study will be shared with other researchers who provide methodologically sound proposal

Publications

  • Styczynski G, Kalinowski P, Cienszkowska K, Ludwiczak M, Strzelczyk J, Szmigielski C. The early impact of bariatric surgery on blood pressure: A hemodynamic analysis using echocardiography in a prospective observational cohort study. Hypertens Res. 2026 May;49(5):1695-1706. doi: 10.1038/s41440-026-02602-y. Epub 2026 Mar 25.

    PubMed 41882327

Questions about this trial

What is this clinical trial studying?

An observational study of Blood Pressure and Obesity, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06460233, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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