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.

Study Overview

• Status: Enrolling by invitation
• Conditions: NAFLD

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This single-center, prospective cohort study will investigate NAFLD patients enrolled in a multidisciplinary immunoglobulin B placement program seen at Methodist Dallas Medical Center (MDMC) beginning January 2023 through December 2026.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Parvez Mantry, Methodist Health System

Publications and helpful links

General Publications

• Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava JL, Wing RR. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology. 2010 Jan;51(1):121-9. doi: 10.1002/hep.23276.
• Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.
• English WJ, DeMaria EJ, Hutter MM, Kothari SN, Mattar SG, Brethauer SA, Morton JM. American Society for Metabolic and Bariatric Surgery 2018 estimate of metabolic and bariatric procedures performed in the United States. Surg Obes Relat Dis. 2020 Apr;16(4):457-463. doi: 10.1016/j.soard.2019.12.022. Epub 2020 Jan 3.
• Bazerbachi F, Vargas EJ, Rizk M, Maselli DB, Mounajjed T, Venkatesh SK, Watt KD, Port JD, Basu R, Acosta A, Hanouneh I, Gara N, Shah M, Mundi M, Clark M, Grothe K, Storm AC, Levy MJ, Abu Dayyeh BK. Intragastric Balloon Placement Induces Significant Metabolic and Histologic Improvement in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2021 Jan;19(1):146-154.e4. doi: 10.1016/j.cgh.2020.04.068. Epub 2020 Apr 30.
• Frutos MD, Morales MD, Lujan J, Hernandez Q, Valero G, Parrilla P. Intragastric balloon reduces liver volume in super-obese patients, facilitating subsequent laparoscopic gastric bypass. Obes Surg. 2007 Feb;17(2):150-4. doi: 10.1007/s11695-007-9040-3.
• Popov VB, Thompson CC, Kumar N, Ciarleglio MM, Deng Y, Laine L. Effect of Intragastric Balloons on Liver Enzymes: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2016 Sep;61(9):2477-87. doi: 10.1007/s10620-016-4178-2. Epub 2016 May 20.
• Sena E, Manzano-Nunez R, Rivera-Esteban J, Pericas JM. Patient-reported outcomes in NAFLD/NASH clinical trials: A blind spot that needs addressing. JHEP Rep. 2022 Sep 22;5(1):100597. doi: 10.1016/j.jhepr.2022.100597. eCollection 2023 Jan. No abstract available.
• Twiss J, Whalley D, Doward L, Balp MM, Brass CA, Cryer D, Sanyal A, Anstee QM. Validation of NASH-CHECK: a novel patient-reported outcome measure for nonalcoholic steatohepatitis. J Patient Rep Outcomes. 2023 Jul 14;7(1):69. doi: 10.1186/s41687-023-00589-5.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 050.HEP.2023.D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No