GAstric Bypass to Treat obEse Patients With steAdy hYpertension

Study Overview
=================
Brief 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

Official Title
-----------------
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.

Conditions
-----------------
Systemic Hypertension, Obesity

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)
* Other: Clinical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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 smokers 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Roux-en-Y gastric bypass<br>Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. | Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)<br>* Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery<br>Other: Clinical treatment<br>* 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.<br>|
| Active Comparator: Clinical treatment<br>Optimized clinical treatment including medical management of hypertension. | Other: Clinical treatment<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs. | 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). | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline in Blood Pressure Levels | Change on systemic blood pressure assessed by ambulatory blood pressure monitoring (ABPM). | 12, 24, 36, 48 and 60 months | 
| Effect on Central Blood Pressure Augmentation Index and Pulse Wave Velocity | Change on central blood pressure augmentation index and pulse wave velocity as measured by SphygmoCor device | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on Systolic Blood Pressure | Absolute change from baseline in systolic blood pressure | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on Diastolic Blood Pressure | Absolute change from baseline in diastolic blood pressure | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on Weight Loss | Absolute change from baseline on weight loss | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on BMI | Absolute change from baseline on BMI | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on Waist Circumference | Absolute change from baseline on waist circumference | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on Fasting Plasm Glucose Level, HbA1c and Insulin Resistance | Change from baseline on fasting plasm glucose level, HbA1c and insulin resistance | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on LDL-cholesterol Level | Absolute change from baseline on LDL-cholesterol level | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on HDL-cholesterol Level | Absolute change from baseline on HDL-cholesterol level | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on Triglycerides Levels | Absolute change from baseline on triglycerides levels | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on Uric Acid Levels | Absolute change from baseline on uric acid levels | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline on Ultra-sensitive CRP Levels | Absolute change from baseline on ultra-sensitive CRP levels | 12, 24, 36, 48 and 60 months | 
| Absolute Change From Baseline of Cardiovascular Risk | Absolute change from baseline of cardiovascular risk calculated by Framingham Score | 12, 24, 36, 48 and 60 months | 
| Change on Heart Anatomy | Change on heart anatomy as evaluated by echocardiogram | 12, 24, 36, 48 and 60 months | 
| Change on Sleep Quality | Change on sleep quality as evaluated by polysomnography | 12, 24, 36, 48 and 60 months | 
| Adverse Events | Describe the main adverse events | At any time during the study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high blood pressure, hypertension, bariatric surgery, Laparoscopic Roux-en-Y gastric bypass (LRYGB), obesity