Clinical Trials Directory

Trials / Completed

CompletedNCT06460233

Blood Pressure Changes After Bariatric Surgery

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

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Medical University of Warsaw · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBariatric surgery - sleeve gastrectomyLaparoscopic sleeve gastrectomy performed according to the current surgical standards

Timeline

Start date
2021-09-21
Primary completion
2025-06-15
Completion
2025-06-15
First posted
2024-06-14
Last updated
2025-07-18

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT06460233. Inclusion in this directory is not an endorsement.