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Enrolling by Invitation

NCT Number: NCT07493967

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

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.

Enrolling by Invitation

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes in Weight

    Time frame: through study completion, up to 18 months

    MeasureTotal body weight loss

  2. Body Mass Index

    Time frame: 1 year

    Measure Body Mass Index

  3. Waist to hip ratio

    Time frame: 1 year

    Measure Waist-to-hip ratio

  4. Aminotransaminases

    Time frame: 1 year

    Measure Aminotransaminases

  5. Fasting Lipids

    Time frame: 1 year

    Measure Fasting Lipids

  6. Fasting Glucose

    Time frame: 1 year

    Measure Fasting Glucose

  7. HbA1c

    Time frame: 1 year

    Measure HbA1c

  8. Changes in liver histology parameters

    Time frame: 1year

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

  9. Changes in liver histology parameters

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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