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

NCT07493967 | Enrolling By Invitation DMC

• 1 other identifier: 050.HEP.2023.D
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NAFLD

Outcome Measures

Primary Outcomes (9)

• Changes in Weight

  MeasureTotal body weight loss

  through study completion, up to 18 months

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Obese (defined as a BMI \>30 kg/m2 )
• Men and women scheduled to undergo immunoglobulin B placement at Methodist Dallas Medical Center(MDMC)
• 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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Related Publications (8)

• 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.

  PMID: 19827166 RESULT

• 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.

  PMID: 32029370 RESULT

• 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.

  PMID: 32360804 RESULT

• 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.

  PMID: 17476864 RESULT

• 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.

  PMID: 27207181 RESULT

• 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.

  PMID: 36536958 RESULT

• 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.

  PMID: 37450086 RESULT

• 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.

  PMID: 14739871 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Parvez Mantry

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: March 27, 2026
• Study Start: February 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-03

Locations

US (1)