[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07493967":3,"trial-entities:NCT07493967":116,"trial-summary:NCT07493967":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":26,"secondary_outcomes":56,"sex":57,"minimum_age":58,"maximum_age":16,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":71,"locations":74,"central_contacts":84,"overall_officials":85,"references":89,"see_also_links":115},"NCT07493967","050.HEP.2023.D","Short and Long Term Clinical and Patient-Reported Outcomes Associated With Intragastric Balloon Placement in Patients With Nonalcoholic Fatty Liver Disease","ENROLLING_BY_INVITATION","2027-02","2026-03","2026-06-10","2024-02-23","Methodist Health System","OTHER",true,"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.",null,[18],"NAFLD",[],"OBSERVATIONAL",[],{"count":23,"type":24},200,"ESTIMATED",[],[27,31,35,38,41,44,47,50,54],{"measure":28,"description":29,"timeFrame":30},"Changes in Weight","MeasureTotal body weight loss","through study completion, up to 18 months",{"measure":32,"description":33,"timeFrame":34},"Body Mass Index","Measure Body Mass Index","1 year",{"measure":36,"description":37,"timeFrame":34},"Waist to hip ratio","Measure Waist-to-hip ratio",{"measure":39,"description":40,"timeFrame":34},"Aminotransaminases","Measure Aminotransaminases",{"measure":42,"description":43,"timeFrame":34},"Fasting Lipids","Measure Fasting Lipids",{"measure":45,"description":46,"timeFrame":34},"Fasting Glucose","Measure Fasting Glucose",{"measure":48,"description":49,"timeFrame":34},"HbA1c","Measure HbA1c",{"measure":51,"description":52,"timeFrame":53},"Changes in liver histology parameters","Nonalcoholic Fatty Liver Disease activity score- Min: 1.455 ,Max: 0.675","1year",{"measure":51,"description":55,"timeFrame":34},"Magnetic resonance electrography- detected liver stiffness\u002F Fibrosis score-Min:2.5 kilopascals, Max: 3.0 kilopascals",[],"ALL","18 Years",false,{"inclusion":61,"exclusion":69,"raw_text":70},[62,63,64,65,66,67,68],"Obese (defined as a BMI \\>30 kg\u002Fm2 )","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","Pregnant women",[],"Inclusion Criteria:\n\n* Obese (defined as a BMI \\>30 kg\u002Fm2 )\n* Men and women scheduled to undergo immunoglobulin B placement at Methodist Dallas Medical Center(MDMC)\n* 18 years or older in age\n* Able to read and understand the study information\n* Personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study\n* Subject is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria\n* Pregnant women",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"city":77,"state":78,"zip":79,"country":80,"geoPoint":81},"Methodist Dallas Medical Center","Dallas","Texas","75203","United States",{"lat":82,"lon":83},32.78306,-96.80667,[],[86],{"name":87,"affiliation":12,"role":88},"Parvez Mantry","PRINCIPAL_INVESTIGATOR",[90,94,97,100,103,106,109,112],{"pmid":91,"type":92,"citation":93},"19827166","RESULT","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\u002Fhep.23276.",{"pmid":95,"type":92,"citation":96},"32029370","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\u002Fj.soard.2019.12.022. Epub 2020 Jan 3.",{"pmid":98,"type":92,"citation":99},"32360804","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\u002Fj.cgh.2020.04.068. Epub 2020 Apr 30.",{"pmid":101,"type":92,"citation":102},"17476864","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\u002Fs11695-007-9040-3.",{"pmid":104,"type":92,"citation":105},"27207181","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\u002Fs10620-016-4178-2. Epub 2016 May 20.",{"pmid":107,"type":92,"citation":108},"36536958","Sena E, Manzano-Nunez R, Rivera-Esteban J, Pericas JM. Patient-reported outcomes in NAFLD\u002FNASH clinical trials: A blind spot that needs addressing. JHEP Rep. 2022 Sep 22;5(1):100597. doi: 10.1016\u002Fj.jhepr.2022.100597. eCollection 2023 Jan. No abstract available.",{"pmid":110,"type":92,"citation":111},"37450086","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\u002Fs41687-023-00589-5.",{"pmid":113,"type":92,"citation":114},"14739871","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\u002Fj.jmpt.2003.11.003.",[],{"nct_id":4,"conditions":117,"biomarkers":119},[118],"Nonalcoholic Fatty Liver Disease",[],{"nct_id":4,"found":59,"summary":16,"prompt_version":16}]