Clinical trial NCT06460233: Blood Pressure Changes After Bariatric Surgery
Official title: Dynamics of Blood Pressure Changes After Bariatric Surgery, Assessed With 24-h Blood Pressure Monitoring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Pressure
Obesity
Bariatric Surgery
Hypertension
Keywords: Hypertension
Obesity
Bariatric surgery
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Central Warsaw Medical University Teaching Hospital
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw
name: Grzegorz Styczynski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: