GAstric Bypass to Treat obEse Patients With steAdy hYpertension (GATEWAY)

Tracking Information
First Submitted Date ICMJE	February 4, 2013
First Posted Date ICMJE	February 6, 2013
Last Update Posted Date	September 20, 2017
Actual Study Start Date ICMJE	May 2013
Actual Primary Completion Date	May 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 30, 2016)	Efficacy of Roux-en-Y Gastroplasty to decrease the number of antihypertensive drugs. [ Time Frame: 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.
Original Primary Outcome Measures ICMJE; (submitted: February 5, 2013)	reduction of hypertension medication prescription [ Time Frame: 12 months ]; Comparison between the two groups (clinical and surgery groups) proportion of > or equal 30% reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after randomization.
Change History	Complete list of historical versions of study NCT01784848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 19, 2017)	Efficacy of Roux-en-Y Gastroplasty to decrease the number of antihypertensive drugs. [ Time Frame: 12, 24, 36, 48 and 60 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).; Absolute change from baseline in blood pressure levels [ Time Frame: 12, 24, 36, 48 and 60 months ]Change on systemic blood pressure assessed by ambulatory blood pressure monitoring (ABPM).; Effect on central blood pressure augmentation index and pulse wave velocity [ Time Frame: 12, 24, 36, 48 and 60 months ]Change on central blood pressure augmentation index and pulse wave velocity as measured by SphygmoCor device; Absolute change from baseline on systolic blood pressure [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline in systolic blood pressure; Absolute change from baseline on diastolic blood pressure [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline in diastolic blood pressure; Absolute change from baseline on weight loss [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline on weight loss; Absolute change from baseline on BMI [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline on BMI; Absolute change from baseline on waist circumference [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline on waist circumference; Absolute change from baseline on fasting plasm glucose level, HbA1c and insulin resistance [ Time Frame: 12, 24, 36, 48 and 60 months ]Change from baseline on fasting plasm glucose level, HbA1c and insulin resistance; Absolute change from baseline on LDL-cholesterol level [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline on LDL-cholesterol level; Absolute change from baseline on HDL-cholesterol level [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline on HDL-cholesterol level; Absolute change from baseline on triglycerides levels [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline on triglycerides levels; Absolute change from baseline on uric acid levels [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline on uric acid levels; Absolute change from baseline on ultra-sensitive CRP levels [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline on ultra-sensitive CRP levels; Absolute change from baseline of cardiovascular risk [ Time Frame: 12, 24, 36, 48 and 60 months ]Absolute change from baseline of cardiovascular risk calculated by Framingham Score; Change on heart anatomy [ Time Frame: 12, 24, 36, 48 and 60 months ]Change on heart anatomy as evaluated by echocardiogram; Change on sleep quality [ Time Frame: 12, 24, 36, 48 and 60 months ]Change on sleep quality as evaluated by polysomnography; Adverse events [ Time Frame: At any time during the study period ]Describe the main adverse events
Original Secondary Outcome Measures ICMJE; (submitted: February 5, 2013)	reduction of hypertension medication prescription . [ Time Frame: 6 and 24 months ]; Comparison between the two groups (clinical and surgery groups) proportion of > or iqual 30% hypertension medication prescription related to the baseline hypertension treatment at 6 and 24 months.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE; (submitted: February 5, 2013)	change from baseline values in blood pressure level [ Time Frame: 12 and 24 months ]mean difference of change from baseline blood pressure values using ambulatory blood pressure monitoring (ABPM)and using Sphygmomanometer blood pressure monitor; change from baseline in corporeal weight and body mass index. [ Time Frame: 12 and 24 months ]; change from baseline fasting plasm glucose level [ Time Frame: 12 and 24 months ]; change from baseline in HbA1c percentual [ Time Frame: 12 and 24 months ]; change from baseline in insulin level [ Time Frame: 12 and 24 months ]; change from baseline in LDL-cholesterol level [ Time Frame: 12 and 24 months ]; change from baseline in HDL-cholesterol level [ Time Frame: 12 and 24 months ]; change from baseline in triglyceride level [ Time Frame: 12 and 24 months ]; change from baseline in antropometric measurements [ Time Frame: 12 and 24 months ]; adverse events [ Time Frame: 15 days, 1, 6, 12 and 24 months ]all adverse reaction reported at least at all follow-up visits.
Descriptive Information
Brief Title ICMJE	GAstric Bypass to Treat obEse Patients With steAdy hYpertension
Official Title ICMJE	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.
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
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Systemic Hypertension; Obesity
Intervention ICMJE	Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB) Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery; Other: Clinical treatment 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.
Study Arms	Experimental: Laparoscopic Roux-en-Y gastric bypass Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. Interventions: Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB) Other: Clinical treatment; Active Comparator: Clinical treatment Optimized clinical treatment including medical management of hypertension. Intervention: Other: Clinical treatment
Publications *	Schiavon CA, Bersch-Ferreira AC, Santucci EV, Oliveira JD, Torreglosa CR, Bueno PT, Frayha JC, Santos RN, Damiani LP, Noujaim PM, Halpern H, Monteiro FLJ, Cohen RV, Uchoa CH, de Souza MG, Amodeo C, Bortolotto L, Ikeoka D, Drager LF, Cavalcanti AB, Berwanger O. Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension). Circulation. 2018 Mar 13;137(11):1132-1142. doi: 10.1161/CIRCULATIONAHA.117.032130. Epub 2017 Nov 13.; Schiavon CA, Ikeoka DT, de Sousa MG, Silva CR, Bersch-Ferreira AC, de Oliveira JD, Noujaim PM, Cohen RV, Amodeo C, Berwanger O; GATEWAY (GAstric bypass surgery to TrEat patients With steAdy hYpertension) Investigators. Effects of gastric bypass surgery in patients with hypertension: rationale and design for a randomised controlled trial (GATEWAY study). BMJ Open. 2014 Sep 8;4(9):e005702. doi: 10.1136/bmjopen-2014-005702.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: May 30, 2016)	100
Original Estimated Enrollment ICMJE; (submitted: February 5, 2013)	60
Estimated Study Completion Date	May 2021
Actual Primary Completion Date	May 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Brazil
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01784848
Other Study ID Numbers ICMJE	IEP2013_HAS
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	Hospital do Coracao
Study Sponsor ICMJE	Hospital do Coracao
Collaborators ICMJE	Ethicon Endo-Surgery
Investigators ICMJE	Principal Investigator: Carlos A Schiavon, MD, PhD Hospital do Coração
PRS Account	Hospital do Coracao
Verification Date	September 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP