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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Hospital do Coracao
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01784848
First received: February 4, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

This is an unicentric phase 3 randomized controlled trial, with allocation concealment, intent-to-treat analysis and mask scheme at outcome assessors level, comparing the effect of Laparoscopic Roux En Y gastric bypass with best medical treatment on reduction of hypertension medications prescription.

The study hypothesis is that gastric bypass is superior than the clinical treatment on reduction the number of hypertension medications.

We also evaluate the effect of Laparoscopic Roux En Y gastric bypass on systemic hypertension levels and others cardiovascular risk factors.


Condition Intervention Phase
Systemic Hypertension
Obesity
Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • reduction of hypertension medication prescription [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Reduce at least 30% of hypertension medication prescription related to the baseline hypertension treatment at 12 months after randomization.


Secondary Outcome Measures:
  • reduction of hypertension medication prescription . [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
    to reduce at least 30% of hypertension medication prescription related to the baseline hypertension treatment at 6 and 24 months.


Other Outcome Measures:
  • absolute change from baseline in blood pressure levels [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    mean difference of change from baseline blood pressure levels using ambulatory blood pressure monitoring (ABPM)and using Sphygmomanometer blood pressure monitor

  • absolute change from baseline in corporeal weight and body mass index. [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • absolute change from baseline in fasting plasm glucose level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • absolute change from baseline in HbA1c percentual [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • absolute change from baseline in insulin levels [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • absolute change from baseline in LDL-cholesterol level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • absolute change from baseline in HDL-cholesterol level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • absolute change from baseline in triglycerides level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • absolute change from baseline in anthropometric measurements [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • any adverse events [ Time Frame: 15 days, 1, 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
    all adverse reactions reported during follow-up visits.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass is one of the techniques of bariatric surgery
Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)
Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery
Active Comparator: best hypertension clinical treatment
best hypertension clinical treatment will be defined according to the principal investigator description
Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)
Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784848

Contacts
Contact: Otavio Berwanger, MD, PhD +5511 30536611 ext 8201 oberwanger@hcor.com.br
Contact: Anna Buehler, PharmD, PhD +5511 30536611 ext 8209 abuehler@hcor.com.br

Locations
Brazil
Research Institute of Cardiac Hospital Recruiting
Sao Paulo, Brazil, 04005-000
Contact: Carlos A Schiavon, MD    +5511 98116 6666    schiavon_ca@gmail.com   
Contact: Anna Buehler, PharmD, PhD    +55 11 30536611 ext 8209    abuehler@hcor.com.br   
Principal Investigator: Carlos A Schiavon, MD         
Sponsors and Collaborators
Hospital do Coracao
Ethicon Endo-Surgery
  More Information

No publications provided

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01784848     History of Changes
Other Study ID Numbers: IEP2013_HAS
Study First Received: February 4, 2013
Last Updated: November 18, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital do Coracao:
high blood pressure
hypertension
bariatric surgery
Laparoscopic Roux-en-Y gastric bypass (LRYGB)
obesity

Additional relevant MeSH terms:
Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014