Dynamics of Blood Pressure Changes After Bariatric Surgery, Assessed With 24-h Blood Pressure Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in the 24-hour blood pressure at one week after bariatric surgery (sleeve gastrectomy)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥40kg/m2 or ≥35 kg/m2 with comorbidities
排除标准
- •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
结局指标
主要结局
Change from baseline in the 24-hour blood pressure at one week after bariatric surgery (sleeve gastrectomy)
时间窗: 1-2 days before and 7 to 10 days after surgery
Mean systolic and diastolic blood pressure in mmHg, measured using 24 hour ambulatory blood pressure monitor
次要结局
- Change from baseline in bedside blood pressure at one month after bariatric surgery(1-2 days before and 28 to 31 days after surgery)
- Change from baseline in the left ventricular systolic function at six months after bariatric surgery(1-2 days before and 5 to 7 months after bariatric surgery)
- Change from baseline in serum fasting insulin level at one year after bariatric surgery(1-2 days before and 11 to 13 months after bariatric surgery)
- Change from baseline in serum Cystatin C level at one year after bariatric surgery(1-2 days before and 11 to 13 months after bariatric surgery)
- Change from baseline in serum NT-proBNP level at one week after bariatric surgery(1-2 days before and 7 to 10 days after bariatric surgery)
- Change from baseline in bedside blood pressure at six months after bariatric surgery(1-2 days before and 5 to 7 months after surgery)
- Change from baseline in cardiac output at six months after bariatric surgery(1-2 days before and 5 to 7 months after surgery)
- Change from baseline in the left ventricular diastolic function at one month after bariatric surgery(1-2 days before and 28 to 31 days after bariatric surgery)
- Change from baseline in serum fasting insulin level at one week after bariatric surgery(1-2 days before and 7 to 10 days after bariatric surgery)
- Change from baseline in serum high- sensivity C-Reactive Protein level at one week after bariatric surgery(1-2 days before and 7 to 10 days after bariatric surgery)
- Change from baseline in serum high- sensivity C-Reactive Protein level at one month after bariatric surgery(1-2 days before and 28 to 31 days after bariatric surgery)
- Change from baseline in serum high- sensivity C-Reactive Protein level at one year after bariatric surgery(1-2 days before and 11 to 13 months after bariatric surgery)
- Change from baseline in serum Cystatin C level at six months after bariatric surgery(1-2 days before and 5 to 7 months after bariatric surgery)
- Change from baseline in serum NT-proBNP level at six months after bariatric surgery(1-2 days before and 5 to 7 months after bariatric surgery)
- Change from baseline in the 24-hour blood pressure at six months after bariatric surgery (sleeve gastrectomy)(1-2 days before and 5 to 7 months after surgery)
- Change from baseline in cardiac output at one year after bariatric surgery(1-2 days before and 11 to 13 months after surgery)
- Change from baseline in the left ventricular systolic function at one week after bariatric surgery(1-2 days before and 7 to 10 days after bariatric surgery)
- Change from baseline in the left ventricular diastolic function at six months after bariatric surgery(1-2 days before and 5 to 7 months after bariatric surgery)
- Change from baseline in the left ventricular diastolic function at one year after bariatric surgery(1-2 days before and 11 to 13 months after bariatric surgery)
- Change from baseline in serum fasting insulin level at six months after bariatric surgery(1-2 days before and 5 to 7 months after bariatric surgery)
- Change from baseline in serum high- sensivity C-Reactive Protein level at six months after bariatric surgery(1-2 days before and 5 to 7 months after bariatric surgery)
- Change from baseline in serum Cystatin C level at one month after bariatric surgery(1-2 days before and 28 to 31 days after bariatric surgery)
- Change from baseline in bedside blood pressure at one week after bariatric surgery(1-2 days before and 7 to 10 days after surgery)
- Change from baseline in the 24-hour blood pressure at one month after bariatric surgery (sleeve gastrectomy)(1-2 days before and 28 to 31 days after surgery)
- Change from baseline in the 24-hour blood pressure at one year after bariatric surgery (sleeve gastrectomy)(1-2 days before and 11 to 13 months after surgery)
- Change from baseline in the left ventricular diastolic function at one week after bariatric surgery(1-2 days before and 7 to 10 days after bariatric surgery)
- Change from baseline in serum fasting insulin level at one month after bariatric surgery(1-2 days before and 28 to 31 days after bariatric surgery)
- Change from baseline in serum NT-proBNP level at one year after bariatric surgery(1-2 days before and 11 to 13 months after bariatric surgery)
- Change from baseline in bedside blood pressure at one year after bariatric surgery(1-2 days before and 11 to 13 months after surgery)
- Change from baseline in cardiac output at one week after bariatric surgery(1-2 days before and 7 to 10 days after surgery)
- Change from baseline in cardiac output at one month after bariatric surgery(1-2 days before and 28 to 31 days after surgery)
- Change from baseline in the left ventricular systolic function at one month after bariatric surgery(1-2 days before and 28 to 31 days after bariatric surgery)
- Change from baseline in the left ventricular systolic function at one year after bariatric surgery(1-2 days before and 11 to 13 months after bariatric surgery)
- Change from baseline in serum Cystatin C level at one week after bariatric surgery(1-2 days before and 7 to 10 days after bariatric surgery)
- Change from baseline in serum NT-proBNP level at one month after bariatric surgery(1-2 days before and 28 to 31 days after bariatric surgery)
研究者
Grzegorz Styczyński
Clinical Professor
Medical University of Warsaw