Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD

Can Bariatric Surgery-Induced Shift in Gut Microbiome Protect Against Non-Alcoholic Fatty Liver Disease? A Step Toward Replicating Metabolic Surgery Results Without Surgery

NCT04263376•The Cleveland Clinic

View on ClinicalTrials.gov

Summary

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 .

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

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).
+8 more criteria

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Key Dates

Start Date

April 24, 2019

Primary Completion Date

January 31, 2022

Completion Date

January 31, 2022

Last Updated

January 5, 2023

Enrollment

ACTUAL participants

Conditions

ObesityDiabetes Mellitus, Type 2NAFLD

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD

Inclusion Criteria

Exclusion Criteria

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