Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Study of Life Expectancy in Patients With Metabolic Syndrome After Weight Loss: a Comparative Randomized Clinical Trial
Brief Summary: Background and study aims:

Surgical and non-surgical normalization of body weight with obesity leads to a significant improvement in health and regression of metabolic syndrome. But as the reduction in body weight with obesity changes the life expectancy remains not clear enough.

The use of endoscopic staplers does not exclude the emergence of serious complications of surgery, for example, including bleeding and leakage in the stapler suture line. Therefore, the advantages of using a band in the bariatrics are justified from a security standpoint.

Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). The proposal to use for the staple-free (stepleless or steplerless) creation of a pouch (band-separated gastric bypass) with use for band a vascular prosthesis is justified, but it requires comparison of this method with a stapler variant.

An important issue is comparing surgical and non-surgical weight loss with obesity and metabolic syndrome and comparing life expectancy with confirmation of changes in telomere length.

This study compares loss of weight, changes in other health conditions that the patient may have (co-morbidities, such as diabetes), telomere length, quality of life, the number of complications and side effects, the degree of complexity of the surgical technique and operating costs of a new laparoscopic band-separated mini- gastric bypass (LBSMGB) procedure compared with the standard stapler (linear cutter) - separated mini-gastric bypass (LSSMGB). Additionally, surgical treatment will be compared with non-surgical treatment (hypocaloric diet therapy).

Who can participate? Obese adult patients with a BMI of between 30 kg/m2 and 50 kg/m2. What does the study involve? Participants are randomly allocated to one of three groups. Those in the first (A) group undergo the laparoscopic band-separated mini-gastric bypass procedure. Those in the second (B) group undergo the linear cutter stapler-separated mini-gastric bypass procedure. In three (C) group including standard lifestyle intervention on weight and hypocaloric diet therapy.

All patients are then followed up one month after surgery and again after 6 and, finally, 12 months after surgery where the changing body mass index, changes in co-morbidities, change telomere length and quality of life are assessed.


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:

* BMI from 30 to 50 kg / m2;
* Metabolic syndrome (MetS) with abdominal adiposity if there are at least two components of MetS from the following: Increase in fasting plasma glucose: detected before diabetes (HbA1 = 5.7-6.4 or 3-fold increase in fasting plasma glucose:\> 5.6 mmol / l); or previously diagnosed type 2 diabetes (HbA1\> 6.5, or glucose\> 6.1); Arterial hypertension AD 130 / 85 mmHg or receiving antihypertensive therapy; Increased triglyceride levels\> 1.7 mmol / L or a specific treatment for this disorder; Reduction of high-density lipoproteins (HDL-C) \<1.03 mmol / L in men and less than 1.29 mmol / L in women or receiving treatment for this disorder;
* The possibility of treatment for 12 months and the possibility of follow up;
* Informed written consent of the patient for randomization and treatment.

Exclusion Criteria:

* Age is less than 18 or more than 65 years;
* BMI less than 30 kg / m2 and more than 50 kg / m2;
* Drug addiction and alcohol consumption;
* Complete immobilization of the patient (paresis / paralysis);
* Presence in the anamnesis bariatric procedures;
* Insulin-dependent diabetes;
* Mental disorders or taking antidepressants;
* Socially vulnerable categories (according to ethical principles);
* Patients who do not understand the purpose of the study;
* Lack of informed written consent.
D: 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.

Answer: C