Phase 3 Randomized Controlled Trial Evaluating the Effect of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on Hypertension Medication Reduction, Blood Pressure Levels and Others Cardiovascular Risk Factors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg
研究概览
简要总结
Phase 3, unicentric, randomized clinical trial, with allocation concealment and intention-to-treat analysis to evaluate the efficacy of videolaparoscopic Roux-en-Y Gastroplasty to decrease the prescription of antihypertensive drugs maintaining normal levels of blood pressure, decrease systemic arterial blood pressure and other risk factors for cardiovascular events compared to clinical treatments of patients with arterial hypertension.
详细描述
Randomization:
The randomization list is electronically generated through specific software. A block randomization is conducted with varying block sizes at the rate of 1:1. Confidentiality of the randomization list is ensured by the central automated randomization system, through the Internet, available 24 hours a day (ACT Clinic - Sistema de Estudos Clínicos do IEP HCor).
Blinding Scheme:
Because the study involves a surgical procedure, investigators and patients cannot be blind for treatment allocated to patients.
Roux-en-Y Gastroplasty Patients allocated to surgical treatment will be admitted to the hospital to be subjected to a Roux-en-Y gastric bypass with a biliopancreatic loop of 100cm and a alimentary limb of 150cm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 65 years old.
- •hypertension diagnosis defined as in use of at least 2 high blood pressure medication at full doses.
- •body mass index between 30,0 and 39,9 kg/m2.
排除标准
- •hypertension ≥ 180/120 mmHg;
- •cerebrovascular diseases in the last 6 months.
- •Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 6 months.
- •Baseline psychiatric disorders: schizophrenia, bipolar disorder, severe depression, psychosis.
- •Renal diseases: diabetic nephropathy, creatinine clearance < 30 ml/min.
- •Patients with secondary hypertension except due to the sleep apnea.
- •Advanced peripheral arterial disease
- •atrophic gastritis
- •Diabetes mellitus type 1 and type 2 with HbA1 c >7,0%
- •alcoholism or use of illicit drugs
- •previous laparotomy
- •severe hepatic disorders
- •Pregnancy or women not using effective contraceptive methods.
- •Recent neoplasm (< 5 years)
- •Immunosuppressant drugs
- •Unable to understanding and follow the study protocol orientations.
结局指标
主要结局
Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg
时间窗: 12 months
Evaluate the efficacy of Roux-en-Y Gastric Bypass on the reduction of the number of antihypertensive drugs, maintaining a controlled blood pressure (\<140x90 mmHg), in 12 months.
次要结局
- Absolute Change From Baseline on Waist Circumference(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline in Blood Pressure Levels(12, 24, 36, 48 and 60 months)
- Effect on Central Blood Pressure Augmentation Index and Pulse Wave Velocity(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on Systolic Blood Pressure(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on Fasting Plasm Glucose Level, HbA1c and Insulin Resistance(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline of Cardiovascular Risk(12, 24, 36, 48 and 60 months)
- Change on Heart Anatomy(12, 24, 36, 48 and 60 months)
- Change on Sleep Quality(12, 24, 36, 48 and 60 months)
- Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs.(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on Diastolic Blood Pressure(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on BMI(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on HDL-cholesterol Level(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on Triglycerides Levels(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on LDL-cholesterol Level(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on Uric Acid Levels(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on Weight Loss(12, 24, 36, 48 and 60 months)
- Absolute Change From Baseline on Ultra-sensitive CRP Levels(12, 24, 36, 48 and 60 months)
- Adverse Events(At any time during the study period)