Short and Long Term Clinical and Patient-Reported Outcomes Associated With Intragastric Balloon Placement in Patients With Nonalcoholic Fatty Liver Disease

Primary outcomes

• Changes in Weight [through study completion, up to 18 months]: MeasureTotal body weight loss
• Body Mass Index [1 year]: Measure Body Mass Index
• Waist to hip ratio [1 year]: Measure Waist-to-hip ratio
• Aminotransaminases [1 year]: Measure Aminotransaminases
• Fasting Lipids [1 year]: Measure Fasting Lipids
• Fasting Glucose [1 year]: Measure Fasting Glucose
• HbA1c [1 year]: Measure HbA1c
• Changes in liver histology parameters [1year]: Nonalcoholic Fatty Liver Disease activity score- Min: 1.455 ,Max: 0.675
• Changes in liver histology parameters [1 year]: Magnetic resonance electrography- detected liver stiffness/ Fibrosis score-Min:2.5 kilopascals, Max: 3.0 kilopascals

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Obese (defined as a BMI >30 kg/m2 )
* Men and women scheduled to undergo immunoglobulin B placement at Methodist Dallas Medical Center(MDMC)
* 18 years or older in age
* Able to read and understand the study information
* Personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
* Subject is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures

Exclusion Criteria:

* Not meeting inclusion criteria
* Pregnant women

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• Parvez Mantry, Principal investigator, Methodist Health System