Blood Pressure Changes After Bariatric Surgery

NCT ID: NCT06460233

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-21
• Study Completion Date: 2025-06-15

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.

Conditions

Blood Pressure; Obesity; Bariatric Surgery; Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with class III obesity (BMI ≥ 40) or class II obesity (BMI 35-40) with comorbidities

Consecutive patients with class III obesity (BMI ≥ 40kg/m2) or class II obesity (BMI 35-40kg/m2) with comorbidities admitted for bariatric surgery (sleeve gastrectomy)

Bariatric surgery - sleeve gastrectomy

Intervention Type: PROCEDURE

Laparoscopic sleeve gastrectomy performed according to the current surgical standards

Interventions

Bariatric surgery - sleeve gastrectomy

Laparoscopic sleeve gastrectomy performed according to the current surgical standards

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Grzegorz Styczyński

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grzegorz Styczynski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

Central Warsaw Medical University Teaching Hospital

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

Other Identifiers

KB/173/2020

Identifier Type: -

Identifier Source: org_study_id