GAstric Bypass to Treat obEse Patients With steAdy hYpertension
Condition: Systemic Hypertension; Obesity
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Antihypertensive Treatment:

      The treatment of hypertension will be standardized for all study patients. Prescribed drugs
      will include preferably a renin-angiotensin blocking system drug and a calcium channels
      blocker, except if these are contraindicated or the patient has achieved good blood pressure
      control using other drugs prior to study recruitment. Other drugs can be added at discretion
      of the attending investigator to achieve a target blood pressure of 130 x 80 mmHg. Patients
      are treated individually for the other associated comorbidities. Obesity treatment in the
      control group includes dietary advice, motivation for the practice of physical activities,
      and drug treatments for diabetes and dyslipidemias if applicable.

      Laboratory tests and other exams:

      All patients will be subjected to the following measurements throughout the study:

        -  Outpatient Blood Pressure Monitoring (ABPM)

        -  Blood pressure measurements taken in doctors' offices:

        -  Central pressure and associated measurements (SphygmoCor®)

        -  Polysomnography

        -  Anthropometry

        -  Nutritional survey

        -  Laboratory tests

        -  Echocardiogram

        -  Electrocardiogram

        -  Abdominal ultrasound

        -  Upper gastrointestinal endoscopy with H.pylori testing
    

Intervention name(s): Laparoscopic Roux-en-Y gastric bypass (LRYGB); Clinical treatment
Intervention type(s): Procedure; Other
Intervention description(s): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery; Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: high blood pressure; hypertension; bariatric surgery; Laparoscopic Roux-en-Y gastric bypass (LRYGB); obesity