Patient description: The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass.

Clinical trial eligibility criteria: eligible ages (years): 20.0-60.0,  Diabetes Obesity 20 to 60 years of age (inclusive) on the date the ICD is signed 2. A BMI ≥ 27 kg/m2 and < 40 kg/m2 3. HbA1c ≥ 8% (63.9 mmol/mol) and ≤ 11% (96.7 mmol/mol) 4. C-peptide ≥ 3 ng/mL (0.999 nmol/L) 5. At least one of the following: 1. Systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg, or on anti-hypertensive medication 2. HDL < 40 mg/dL (1.0344 mmol/L) (men) or < 50 mg/dL (1.293 mmol/L) (women), or on medication for low HDL 3. LDL > 100 mg/dL (2.586 mmol/L), or on medication for high LDL 4. TG ≥ 150 mg/dL (1.694 mmol/L) or on TG lowering medication treatment 5. FPG ≥ 100 mg/dL (5.556 mmol/L) or on medication for hyperglycemia or anti-T2DM 6. Able to comprehend and sign the EC-approved trial ICD  Unable or unwilling to attend follow-up visits and examinations 2. History of drug and/or alcohol abuse within 2 years of Screening Visit 3. Any previous major GI surgery (e.g., any GI surgery with a resection, etc.) Examples of previous GI surgery allowed appendectomy, gall bladder surgery, liver biopsies, endoscopic procedures, etc. 4. Scheduled concurrent surgical procedure 5. Women of childbearing potential who are pregnant or lactating at the time of screening, at the time of surgery, or planning to become pregnant during the follow-up period 6. Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression, or history of suicide attempts 7. Any condition which precludes compliance with the trial, including: 1. Inflammatory diseases of the GI tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years 2. History of Hepatitis B or C 3. T1DM 4. LADA (confirmed by positive GAD autoantibodies, IAA, and ICA) 5. Immunocompromised such as that resulting from chronic oral steroid use, cancer chemotherapeutic agents, or immune deficiency disorders 8. Screening laboratory tests with any of the following: 1. ALT and/or AST levels ≥ 4 times ULN according to laboratory normal ranges 2. Blood creatinine level ≥ 1.5 times ULN according to laboratory normal ranges 3. BUN level ≥ 1.5 times ULN according to laboratory normal ranges 9. Use of any of the following medications in the past 120 days: 1. Chronic steroid use 2. Prescription or over-the-counter medications or supplements with a primary indication known to cause or assist in weight reduction 10. Use of any of the following medications in the past 60 days: a. Promotility agents 11. Any other medical condition or finding for which, at the discretion of the PI, the subject should be excluded 12. Participation in any other clinical trial (not to registries or survey-only studies) within 30 days or 5 half lives of an investigational drug (which ever is longer), of Visit 1 (Screening Visit) and for the duration of the trial