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Enrolling by invitation NCT07493967

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

— Observational NAFLD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: NAFLD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Primary outcome measures

  • Changes in Weight [Time frame: through study completion, up to 18 months]
  • Body Mass Index [Time frame: 1 year]
  • Waist to hip ratio [Time frame: 1 year]
  • Aminotransaminases [Time frame: 1 year]
  • Fasting Lipids [Time frame: 1 year]
  • Fasting Glucose [Time frame: 1 year]
  • HbA1c [Time frame: 1 year]
  • Changes in liver histology parameters [Time frame: 1year]
  • Changes in liver histology parameters [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Methodist Dallas Medical Center — Dallas

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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 14739871

Identifiers

NCT: NCT07493967 · 050.HEP.2023.D

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗