Metabolic Factors of Outcomes From Gastric Bypass Surgery

Exclusion Criteria

• •Subjects meeting the following criteria will not be eligible for enrollment:
• •1. Unable or unwilling to attend follow-up visits and examinations
• •2. Women who are pregnant, nursing at the time of screening, or planning to become pregnant within one year of the GB surgery
• •3. Clinically active cardiac, renal, hepatic or GI disorders
• •4. Screening laboratory tests with any of the following:
• •* alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] ≥ 4 times upper limit of normal (ULN) according to VAMC normal ranges
• •* AST:ALT \> 2:1 according to VAMC normal ranges
• •* Serum Creatinine ≥ 1.5 times ULN according to VAMC normal ranges
• •* Blood Urea Nitrogen (BUN) ≥ 1.5 times ULN according to VAMC normal ranges
• •* Positive test results for Hepatitis A, B or C
• •5. Clinically active thyroid or lipid disorders:
• •* Thyroid-stimulating hormone (TSH) flagged as critical value (per VAMC lab normal ranges)
• •* Triglycerides \> 400 mg/dL
• •6. Anemia:
• •* Mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC) outside normal VAMC range; or
• •* Hematocrit \< 36%
• •7. Uncontrolled hypertension which required a medication regimen adjustment during the 3 months prior to screening
• •8. Currently prescribed or taking atypical antipsychotic medication
• •9. Currently prescribed or taking chronic, long-term, oral corticosteroid medication
• •10. Diabetes requiring a drug regimen which includes insulin treatment at the time of screening
• •11. Unwilling or unable to refrain from having a procedure or surgery which involves the removal of skin tissue which could result in weight loss
• •12. Any medical condition or finding for which the PI used medical discretion to determine the subject should be excluded; or
• •13. Participation in any other investigational device or drug study (non survey based trial) during the course of the trial.