Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD
Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD
This study is designed as a prospective pilot study for longitudinal assessment of fecal
 microbiome related to medical and surgical weight loss. The investigators follow the standard
 of care for perioperative and intraoperative management of study participants. The only
 addition to the standard of care protocol will be collection of fecal samples at 3 time
 points. This will enable investigators to compare changes in and effects by microbiota after
 low-calorie diet versus after bariatric surgery .
Inclusion Criteria:

 -  Be an eligible candidate for bariatric surgery based on standard criteria in place,
 have been enrolled in bariatric surgery program at Cleveland Clinic Main Campus, and
 have been cleared and approved for bariatric surgery by the BMI bariatric program and
 his/her health insurance

 -  Have a Body Mass Index (BMI) more than 35 kg/m2

 -  Have type 2 diabetes (T2D) (but not type 1 diabetes, see exclusion criteria) as
 defined by

 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.

 Exclusion Criteria:

 -  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.