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

February 4, 2013
November 18, 2013
January 2013
October 2014   (final data collection date for primary outcome measure)
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.
reduction of hypertension medication prescription [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01784848 on ClinicalTrials.gov Archive Site
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.
reduction of hypertension medication prescription . [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
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.
  • 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.
  • change from baseline values in blood pressure level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • change from baseline fasting plasm glucose level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • change from baseline in HbA1c percentual [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • change from baseline in insulin level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • change from baseline in LDL-cholesterol level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • change from baseline in HDL-cholesterol level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • change from baseline in triglyceride level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • change from baseline in antropometric measurements [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 15 days, 1, 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
    all adverse reaction reported at least at all follow-up visits.
 
GAstric Bypass to Treat obEse Patients With steAdy hYpertension
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Systemic Hypertension
  • Obesity
Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)
Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery
  • Experimental: Laparoscopic Roux-en-Y gastric bypass
    Laparoscopic Roux-en-Y gastric bypass is one of the techniques of bariatric surgery
    Intervention: Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)
  • Active Comparator: best hypertension clinical treatment
    best hypertension clinical treatment will be defined according to the principal investigator description
    Intervention: Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)
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.
 
Recruiting
60
October 2015
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
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
Brazil
 
NCT01784848
IEP2013_HAS
No
Hospital do Coracao
Hospital do Coracao
Ethicon Endo-Surgery
Not Provided
Hospital do Coracao
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP