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

N/AEnrolling By InvitationNCT07493967

Methodist Health System200 enrolled

Overview

This study aims to enroll a robust cohort of NAFLD patients who undergo Intragastric Balloon placement through a multidisciplinary program approach to evaluate clinical and patient-reported outcomes for at least one-year post-placement.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

NAFLD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Methodist Dallas Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Changes in Weight

MeasureTotal body weight loss

Time frame: through study completion, up to 18 months

Body Mass Index

Measure Body Mass Index

Time frame: 1 year

Waist to hip ratio

Measure Waist-to-hip ratio

Time frame: 1 year

Aminotransaminases

Measure Aminotransaminases

Time frame: 1 year

Fasting Lipids

Measure Fasting Lipids

Time frame: 1 year

Fasting Glucose

Measure Fasting Glucose

Time frame: 1 year

HbA1c

Measure HbA1c

Time frame: 1 year

Changes in liver histology parameters

Nonalcoholic Fatty Liver Disease activity score- Min: 1.455 ,Max: 0.675

Time frame: 1year

Changes in liver histology parameters

Magnetic resonance electrography- detected liver stiffness/ Fibrosis score-Min:2.5 kilopascals, Max: 3.0 kilopascals

Time frame: 1 year

Data from ClinicalTrials.gov

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