Please select the eligibility criteria that correspond to the clinical trial below.
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.
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.


Options:
A: Inclusion Criteria:

1. Provide written informed consent.
2. Be male or female subjects between the ages of 22-60 years.
3. If female, be either post-menopausal, surgically sterile or agree to practice birth control during year of study and have negative serum HCG at screening and baseline.
4. Have a Body Mass Index (BMI) of ≥30 and \<35 with at least one non-severe co-morbid obesity related condition or a BMI ≥ 35 and \< 40 with or without a non-severe obesity related co-morbid condition, where a severe co-morbid condition is defined as severe if symptoms cause severe discomfort, performance of daily activities is compromised, and/or condition is not entirely controlled with prescription drug therapy.
5. Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
6. Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).
7. Agrees not to have any additional weight loss interventional procedures, liposuction, or take any over the counter or prescription weight loss medication for 24 months following study enrollment.
8. Have not taken any prescription or over the counter weight loss medications for at least 6 months and agrees not to utilize for 12 months following study enrollment.
9. Be willing to cooperate with post-operative dietary recommendations and assessment tests.
10. Reside within a reasonable distance from the Investigator's treating office (\~50 miles) and able and willing to travel to the Investigator's office to complete all routine follow-up visits.

Exclusion Criteria:

1. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments.
3. Severe gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with prescription drug therapy.
4. Large hiatal hernia (\>3 cm) by history or as determined by pre-randomization endoscopy.
5. Pancreatic insufficiency/disease.
6. Active gastric erosions or gastric/duodenal ulcer.
7. History of gastroparesis or symptoms that would be suggestive of gastroparesis.
8. Pregnancy or plans of pregnancy in the next 12 months.
9. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
10. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
11. History or present use of insulin or insulin derivatives for treatment of diabetes
12. Type II Diabetes Mellitus (as defined by HgbA1c \>6.5%) for greater than 10 years at the time of enrollment
13. Quit smoking within the last 6 months at time of enrollment or plans to quit smoking in the year after enrollment
14. Portal hypertension and/or varices.
15. Gastric outlet obstruction or stenosis.
16. Significant abnormality identified during Visit 2 (randomization visit) with endoscopy revealing large hiatal hernia, gastric ulcer, gastric erosions, etc.
17. Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
18. Beck Depression Inventory (Short) Score ≥12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
19. Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment.
20. Non-ambulatory or has significant impairment of mobility.
21. Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
22. Participating in another clinical study.
23. Is a relative of investigator or his/her staff, or is employed by investigator or institution involved in the study.
24. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
B: Inclusion Criteria: Population based sample with inclusion of any patient seen by primary care or institutional physician/pediatrician, regardless of the objective for the visit (well child visits, acute visits or special requests)

Exclusion Criteria: none
C: 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.
D: Inclusion Criteria:

* Aged 14 to 16
* Age and sex adjusted BMI \>40 kg/m2 or \>35 kg/m2 with associated co-morbidity.

  \* Associated co-morbidity includes: glucose intolerance, type 2 diabetes, hypertension, pseudotumor cerebri, acanthosis nigricans, obstructive sleep apnoea syndrome, depression, arthropathies, non-alcoholic steatohepatitis and dyslipidemia.
* \> 1 year multidisciplinary organized weight reducing attempts with less than 5% weight loss
* Demonstrate decisional capacity

Exclusion Criteria:

* Psychologically not suitable
* Pre-menarche or bone age \<15 years in boys
* Obesity associated to other disorders such as hypothyroidism
* Syndromal disorders such as Prader-Willi syndrome
* Severe cardiorespiratory impairment (ASA class 3 or higher)
* Insufficiently fluid in the Dutch language
* Unwillingness to adhere to follow-up programmes

Answer: C