CClinicalTrials.gg
Sign In
Enrolling by invitationNCT07493967Updated Jun 10, 2026

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

An observational study in NAFLD, sponsored by Methodist Health System. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • NAFLD
03

In context

Non-alcoholic Fatty Liver Disease

1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 200 is above the median of 150 across 353 observational studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Not meeting inclusion criteria
  • Pregnant women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Changes in Weight

    MeasureTotal body weight loss

    Time frame: through study completion, up to 18 months

  2. Body Mass Index

    Measure Body Mass Index

    Time frame: 1 year

  3. Waist to hip ratio

    Measure Waist-to-hip ratio

    Time frame: 1 year

  4. Aminotransaminases

    Measure Aminotransaminases

    Time frame: 1 year

  5. Fasting Lipids

    Measure Fasting Lipids

    Time frame: 1 year

  6. Fasting Glucose

    Measure Fasting Glucose

    Time frame: 1 year

  7. HbA1c

    Measure HbA1c

    Time frame: 1 year

  8. Changes in liver histology parameters

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

    Time frame: 1year

  9. 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

07

Study locations

1 site
  • Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
08

References and documents

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. PubMed 19827166 ↗
  • 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. PubMed 32029370 ↗
  • 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. PubMed 32360804 ↗
  • 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. PubMed 17476864 ↗
  • 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. PubMed 27207181 ↗
  • 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. PubMed 36536958 ↗
  • 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. PubMed 37450086 ↗
  • 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. PubMed 14739871 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07493967
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
Feb 23, 2024
Primary completion
Dec 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

Parvez Mantry
principal investigator · Methodist Health System

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Non-alcoholic Fatty Liver Disease→

Other studies from this sponsor

Methodist Health System

Start the discussion