A Trial of the Jejunal Diversion Procedure

Exclusion Criteria

• •1. 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 include: 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 include 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