Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460233
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-24
Brief Title:
Blood Pressure Changes After Bariatric Surgery
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
Dynamics of Blood Pressure Changes After Bariatric Surgery Assessed With 24-h Blood Pressure Monitoring
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 40kgm2 or class II obesity BMI 35-40kgm2 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
Description of the study
Patients consecutive patients with class III obesity BMI 40kgm2 or class II obesity BMI 35-40kgm2 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 SpacelabsUSA 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
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 SpacelabsUSA 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None