Systemic Hypertension, Obesity
Conditions
Keywords
high blood pressure, hypertension, bariatric surgery, Laparoscopic Roux-en-Y gastric bypass (LRYGB), obesity
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
Interventions
PROCEDURELaparoscopic Roux-en-Y gastric bypass (LRYGB)
Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery
OTHERClinical 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.
Sponsors
Ethicon Endo-Surgery
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Blood Pressure Levels | 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 | 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 | 12, 24, 36, 48 and 60 months | Absolute change from baseline in systolic blood pressure |
| Absolute Change From Baseline on Diastolic Blood Pressure | 12, 24, 36, 48 and 60 months | Absolute change from baseline in diastolic blood pressure |
| Absolute Change From Baseline on Weight Loss | 12, 24, 36, 48 and 60 months | Absolute change from baseline on weight loss |
| Absolute Change From Baseline on BMI | 12, 24, 36, 48 and 60 months | Absolute change from baseline on BMI |
| Absolute Change From Baseline on Waist Circumference | 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 | 12, 24, 36, 48 and 60 months | Change from baseline on fasting plasm glucose level, HbA1c and insulin resistance |
| Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs. | 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 on HDL-cholesterol Level | 12, 24, 36, 48 and 60 months | Absolute change from baseline on HDL-cholesterol level |
| Absolute Change From Baseline on Triglycerides Levels | 12, 24, 36, 48 and 60 months | Absolute change from baseline on triglycerides levels |
| Absolute Change From Baseline on Uric Acid Levels | 12, 24, 36, 48 and 60 months | Absolute change from baseline on uric acid levels |
| Absolute Change From Baseline on Ultra-sensitive CRP Levels | 12, 24, 36, 48 and 60 months | Absolute change from baseline on ultra-sensitive CRP levels |
| Absolute Change From Baseline of Cardiovascular Risk | 12, 24, 36, 48 and 60 months | Absolute change from baseline of cardiovascular risk calculated by Framingham Score |
| Change on Heart Anatomy | 12, 24, 36, 48 and 60 months | Change on heart anatomy as evaluated by echocardiogram |
| Change on Sleep Quality | 12, 24, 36, 48 and 60 months | Change on sleep quality as evaluated by polysomnography |
| Adverse Events | At any time during the study period | Describe the main adverse events |
| Absolute Change From Baseline on LDL-cholesterol Level | 12, 24, 36, 48 and 60 months | Absolute change from baseline on LDL-cholesterol level |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laparoscopic Roux-en-Y Gastric Bypass Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity.
Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery
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. | 50 |
| Clinical Treatment Optimized clinical treatment including medical management of hypertension.
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. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Laparoscopic Roux-en-Y Gastric Bypass | Clinical Treatment | Total |
|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 9.2 | 44.6 years STANDARD_DEVIATION 9.2 | 43.8 years STANDARD_DEVIATION 9.2 |
| Anti-hypertensive medications | 3 Anti-hypertensive medications | 3 Anti-hypertensive medications | 3 Anti-hypertensive medications |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 16 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 34 Participants | 65 Participants |
| Sex: Female, Male Female | 41 Participants | 35 Participants | 76 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 47 |
| other Total, other adverse events | 0 / 49 | 1 / 47 |
| serious Total, serious adverse events | 6 / 49 | 0 / 47 |
Outcome results
Primary
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laparoscopic Roux-en-Y Gastric Bypass | Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg | 41 Participants |
| Clinical Treatment | Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg | 6 Participants |
Secondary
Absolute Change From Baseline in Blood Pressure Levels
Change on systemic blood pressure assessed by ambulatory blood pressure monitoring (ABPM).
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline of Cardiovascular Risk
Absolute change from baseline of cardiovascular risk calculated by Framingham Score
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on BMI
Absolute change from baseline on BMI
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on Diastolic Blood Pressure
Absolute change from baseline in diastolic blood pressure
Time frame: 12, 24, 36, 48 and 60 months
Secondary
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
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on HDL-cholesterol Level
Absolute change from baseline on HDL-cholesterol level
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on LDL-cholesterol Level
Absolute change from baseline on LDL-cholesterol level
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on Systolic Blood Pressure
Absolute change from baseline in systolic blood pressure
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on Triglycerides Levels
Absolute change from baseline on triglycerides levels
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on Ultra-sensitive CRP Levels
Absolute change from baseline on ultra-sensitive CRP levels
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on Uric Acid Levels
Absolute change from baseline on uric acid levels
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on Waist Circumference
Absolute change from baseline on waist circumference
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Absolute Change From Baseline on Weight Loss
Absolute change from baseline on weight loss
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Adverse Events
Describe the main adverse events
Time frame: At any time during the study period
Secondary
Change on Heart Anatomy
Change on heart anatomy as evaluated by echocardiogram
Time frame: 12, 24, 36, 48 and 60 months
Secondary
Change on Sleep Quality
Change on sleep quality as evaluated by polysomnography
Time frame: 12, 24, 36, 48 and 60 months
Secondary
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
Time frame: 12, 24, 36, 48 and 60 months
Secondary
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).
Time frame: 12, 24, 36, 48 and 60 months