Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD

Exclusion Criteria

• •1. If untreated (as per ADA standards of care) FPG \> or = 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h OR 2-h PG \> or = 200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water OR A1C \> or = 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay OR In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose \> or = 200 mg/dL (11.1 mmol/L).
• •2. the use of any antidiabetic drug or glucose lowering agent, including biguanides (metformin), thiazolidinediones, alpha-glucosidase inhibitors, sulfonylurea, meglitinides, DPP4-inhibitors, GLP1-agonists, SGLT2i, any type of insulin.
• •Have the ability and willingness to participate in the study and agree to the study terms
• •As a standard of care, have a negative urine pregnancy test prior to surgery for women of childbearing potential. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
• •Any contra-indication for bariatric surgery (standard of care)
• •Lack of insurance coverage for bariatric surgery
• •Diabetes mellitus other than T2D including Type 1 diabetes or Latent Autoimmune Diabetes of the Adult (LADA) as defined by personal history of diabetic ketoacidosis or by positive auto-antibodies to glutamic Acid Decarboxylase (GAD-65), Islet Cell Antibodies (ICA), Insulin Autoantibodies (IAA), or to protein tyrosine phosphatase (IA-2A) Monogenetic or neonatal diabetes
• •Prior bariatric surgery of any kind.
• •Known history of chronic liver disease except for NAFLD/NASH: hepatitis, positive serologic test result for hepatitis B surface antigen and/or hepatitis C antibody, alpha-1-antitrypsin deficiency.
• •Known Gastrointestinal disorders including a known history of celiac disease and/or any other malabsorptive disorders or inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• •Psychiatric disorders including dementia, active psychosis, severe depression requiring \> 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months.
• •Smoking within the previous 3 months.
• •Pregnancy.
• •Malignancy within five years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early / stage 1 cancer that have been successfully treated are eligible per Investigator discretion.
• •Use of any medications (prescription or OTC), including herbal or other supplements for treatment of obesity, or liver conditions at the time of consent.
• •Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study.
• •Unable to understand the risks, realistic benefits and compliance requirements of each program.
• •Use of investigational therapy or participation in any other clinical trial within 12 weeks prior to signing the ICF.