GAstric Bypass to Treat obEse Patients With steAdy hYpertension (GATEWAY)
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ClinicalTrials.gov Identifier: NCT01784848 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 6, 2013
Last Update Posted
: September 20, 2017
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Tracking Information | ||||
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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 |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | Complete list of historical versions of study NCT01784848 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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.
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE |
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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:
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
100 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Responsible Party | Hospital do Coracao | |||
Study Sponsor ICMJE | Hospital do Coracao | |||
Collaborators ICMJE | Ethicon Endo-Surgery | |||
Investigators ICMJE |
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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 |