Metabolic Dysfunction-associated Steatotic Liver DiseaseMASLDNCT06328452
Risk Factors and Impact MASLD in Patients With IBD
An observational study of Metabolic Dysfunction-associated Steatotic Liver Disease, run by Assiut University.
Trial summary
Inflammatory bowel disease (IBD) is a chronic disease characterized by remitting and relapsing inflammation of the gastrointestinal tract. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD and their incidence and prevalence are increasing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-associated Steatotic Liver Disease
- What is being tested?
- FibroScan
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 30 Jun 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This will be a prospective cohort study, conducted in Al Rajhi University Hospital, Assiut University from April 2024 till October 2025. The study population will be recruited from patients attending the IBD Outpatient Clinic and will be categorized into two groups (IBD with MASLD and IBD without MASLD).
Who may be able to join
- Eligible patients will be older than 18 years with an IBD diagnosis according to clinical, laboratory, endoscopic and histopathological evaluation (according to European Crohn's and Colitis Organization (ECCO)) (Maaser et al., 2019)
Who cannot join
- IBD patients with any of the following conditions will be excluded:
- Patients with a history of alcohol or drug abuse
- Patients with HCV or HBV infection
- Patients with autoimmune liver disease
- Hepatic malignancies (primary or secondary)
- Pregnant women
About this study
Official title: Risk Factors and Impact of Metabolic Dysfunction -Associated Steatotic Liver Disease in Patients With Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a chronic disease characterized by remitting and relapsing inflammation of the gastrointestinal tract. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD and their incidence and prevalence are increasing.
In about 5-50% of patients with IBD, there are several extraintestinal manifestations as primary sclerosing cholangitis, autoimmune/granulomatous hepatitis, and non-alcoholic fatty liver disease (NAFLD).
Read more
Metabolic dysfunction-associated steatotic liver disease "MASLD"(formerly NAFLD) is a spectrum of hepatic diseases associated with metabolic and cardiovascular disorders, such as obesity, insulin resistance (IR), hypertension, dyslipidemia, impaired glucose tolerance and type 2 diabetes mellitus.
The risk factors of developing liver steatosis in patients with IBD remain undetermined. Some studies have supported traditional risk factors, such as type 2 Diabetes mellitus (T2DM), weight gain, or obesity, to contribute to MAFLD development in patients with IBD. Other studies have highlighted the involvement of disease activity, duration, drug-induced liver injury and small bowel surgeries in MAFLD progression.
Limited data are available on the frequency and risk factors of MASLD in Egyptian patients with IBD, and no published Egyptian study has addressed the clinical utility of serum steatosis markers in MASLD prediction in IBD population. Moreover, the impact of MASLD on IBD course is unclear. Therefore, we will conduct our study to shed some light on this issue.
Read the detailed description
Inflammatory bowel diseases (IBD) are chronic diseases characterized by remitting and relapsing inflammation of the gastrointestinal tract, with negative effects on the patients' social function and quality of life. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD that present specific characteristics and their incidence and prevalence are globally increasing.
In about 5-50% of patients with IBD, there are several extraintestinal manifestations such as musculoskeletal, ocular, cutaneous, and hepatobiliary. Hepatobiliary manifestations include primary sclerosing cholangitis, autoimmune/granulomatous hepatitis, and in particular, non-alcoholic fatty liver disease (NAFLD).
NAFLD currently the most common chronic liver disease worldwide. Its global prevalence increased over 3 decades from 25.3% to 38%.
NAFLD is a spectrum of hepatic diseases associated with metabolic and cardiovascular disorders, such as obesity, insulin resistance (IR), hypertension, dyslipidemia, impaired glucose tolerance and type 2 diabetes mellitus. It is frequently recognized as the hepatic manifestation of metabolic syndrome.
Therefore, a new broader nomenclature has been introduced that is "Metabolic Dysfunction-associated Fatty Liver Disease" (MAFLD). More recently, a multi society Delphic consensus statement on a new nomenclature of fatty liver disease was published, introducing the term "Metabolic Dysfunction- associated Steatotic Liver Disease (MASLD) to make the term NAFLD retired.
Estimates of liver steatosis prevalence in IBD patients vary widely from 8% to 88%. This could be explained by heterogeneity of the diagnostic methods and the selected study population.
The risk factors of developing liver steatosis in patients with IBD remain undetermined. Some studies have supported traditional risk factors, such as type 2 Diabetes mellitus (T2DM), weight gain, or obesity, to contribute to MAFLD development in patients with IBD. Other studies have highlighted the involvement of disease activity, duration, drug-induced liver injury and small bowel surgeries in MAFLD progression.
Several serum scores (biomarkers) have been developed to predict the presence or absence of hepatic steatosis. These scores have been extensively validated both for the general population and obese population. However, little is known about their usefulness in prediction of steatosis in IBD patients.
IBD and fatty liver disease are both associated with considerable healthcare expenditures, and their increasing prevalence would undoubtedly impose a growing economic burden. Moreover, IBD patients with concurrent fatty liver disease are potentially at a higher risk of liver abnormalities compared with those without, which can affect the clinical management of the patients with IBD.
Soni reported greater mortality, morbidity and health care resources utilization in patients with IBD who were hospitalized with concomitant diagnosis of NAFLD.
- Being tested
- FibroScan
- Keywords
- MASLD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScanDevice
All the study population will be submitted to Fibroscan examination with CAP (Echosens FibroScan® Compact 530). To evaluate steatosis and fibrosis, participants will be asked to fast for at least 3 hours before the test. To capture a controlled attenuation parameter (CAP) score and liver stiffness measurement (LSM), 10 valid scans per subject will be needed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the prevalence and risk factors of metabolic dysfunction associated steatotic liver disease among patients attending inflammatory bowel disease outpatient clinic
Assess the prevalence and risk factors of metabolic dysfunction associated steatotic liver disease among patients attending inflammatory bowel disease outpatient clinic
Measured: 3 months from 1st April to 30th June 2024
Effect of metabolic dysfunction associated steatotic liver disease on inflammatory bowel disease course
Effect of metabolic dysfunction associated steatotic liver disease on inflammatory bowel disease course (the rate of clinical relapse that will be defined as any occurence of IBD-related admission, surgery, as well as the first use of corticosteroids, immunomodulators or biological agents (either bio-naive or bio-experienced patients) during follow up.
Measured: from 1st April 2024 to 30th June 2025
Secondary outcomes (1)
Performance of serum steatosis markers in prediction of steatosis
Serum steatosis markers: hepatic steatosis index (8 x (ALT/AST ratio) + BMI ( weight and height will be combined to report BMI in kg/m^2) (+2, if female; +2, if diabetes mellitus) will be calculated.
Measured: from 1st April 2024 to 30th June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Nasr El Din Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328452
- Sponsor's protocol ID
- MASLD
- Acronym
- MASLD
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams LC, Lubbe F, Bressem K, Wagner M, Hamm B, Makowski MR. Non-alcoholic fatty liver disease in underweight patients with inflammatory bowel disease: A case-control study. PLoS One. 2018 Nov 14;13(11):e0206450. doi: 10.1371/journal.pone.0206450. eCollection 2018.
PubMed 30427909Ali MaEH, Kamal GM, Younis MaA, et al. Diagnostic performance of serum steatosis biomarkers in Prediction of Non Alcoholic Fatty Liver Disease in Adult Asymptomatic Egyptians. SVU-International Journal of Medical Sciences, (2022); 5(2): 51-63.
Allen AM, Van Houten HK, Sangaralingham LR, Talwalkar JA, McCoy RG. Healthcare Cost and Utilization in Nonalcoholic Fatty Liver Disease: Real-World Data From a Large U.S. Claims Database. Hepatology. 2018 Dec;68(6):2230-2238. doi: 10.1002/hep.30094. Epub 2018 Sep 20.
PubMed 29774589Barberio B, Zamani M, Black CJ, Savarino EV, Ford AC. Prevalence of symptoms of anxiety and depression in patients with inflammatory bowel disease: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2021 May;6(5):359-370. doi: 10.1016/S2468-1253(21)00014-5. Epub 2021 Mar 12.
PubMed 33721557Buzzetti E, Pinzani M, Tsochatzis EA. The multiple-hit pathogenesis of non-alcoholic fatty liver disease (NAFLD). Metabolism. 2016 Aug;65(8):1038-48. doi: 10.1016/j.metabol.2015.12.012. Epub 2016 Jan 4.
PubMed 26823198Cai W, Cagan A, He Z, Ananthakrishnan AN. A Phenome-Wide Analysis of Healthcare Costs Associated with Inflammatory Bowel Diseases. Dig Dis Sci. 2021 Mar;66(3):760-767. doi: 10.1007/s10620-020-06329-9. Epub 2020 May 20.
PubMed 32436120Capela TL, Silva VM, Freitas M, Arieira C, Goncalves TC, de Castro FD, Magalhaes J, Cotter J. Identifying inflammatory bowel disease patients at risk of metabolic dysfunction-associated fatty liver disease: usefulness of non-invasive steatosis predictive scores. BMC Gastroenterol. 2023 Dec 13;23(1):437. doi: 10.1186/s12876-023-02988-w.
PubMed 38093213Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
PubMed 32278004Haas L, Chevalier R, Major BT, Enders F, Kumar S, Tung J. Biologic Agents Are Associated with Excessive Weight Gain in Children with Inflammatory Bowel Disease. Dig Dis Sci. 2017 Nov;62(11):3110-3116. doi: 10.1007/s10620-017-4745-1. Epub 2017 Sep 11.
PubMed 28895012Hsiao SW, Chen TC, Su PY, Yang CT, Huang SP, Chen YY, Yen HH. Metabolic Dysfunction-Associated Fatty Liver Disease in Taiwanese Patients with Inflammatory Bowel Disease: A Study in Patients with Clinical Remission. Diagnostics (Basel). 2023 Oct 20;13(20):3268. doi: 10.3390/diagnostics13203268.
PubMed 37892089Keys A, Fidanza F, Karvonen MJ, Kimura N, Taylor HL. Indices of relative weight and obesity. J Chronic Dis. 1972 Jul 1;25(6):329-43. doi: 10.1016/0021-9681(72)90027-6. No abstract available.
PubMed 4650929Lapumnuaypol K, Kanjanahattakij N, Pisarcik D, Thongprayoon C, Wijarnpreecha K, Cheungpasitporn W. Effects of inflammatory bowel disease treatment on the risk of nonalcoholic fatty liver disease: a meta-analysis. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):854-860. doi: 10.1097/MEG.0000000000001144.
PubMed 29697458Maaser C, Sturm A, Vavricka SR, Kucharzik T, Fiorino G, Annese V, Calabrese E, Baumgart DC, Bettenworth D, Borralho Nunes P, Burisch J, Castiglione F, Eliakim R, Ellul P, Gonzalez-Lama Y, Gordon H, Halligan S, Katsanos K, Kopylov U, Kotze PG, Krustins E, Laghi A, Limdi JK, Rieder F, Rimola J, Taylor SA, Tolan D, van Rheenen P, Verstockt B, Stoker J; European Crohn's and Colitis Organisation [ECCO] and the European Society of Gastrointestinal and Abdominal Radiology [ESGAR]. ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 1: Initial diagnosis, monitoring of known IBD, detection of complications. J Crohns Colitis. 2019 Feb 1;13(2):144-164. doi: 10.1093/ecco-jcc/jjy113. No abstract available.
PubMed 30137275Magri S, Paduano D, Chicco F, Cingolani A, Farris C, Delogu G, Tumbarello F, Lai M, Melis A, Casula L, Fantini MC, Usai P. Nonalcoholic fatty liver disease in patients with inflammatory bowel disease: Beyond the natural history. World J Gastroenterol. 2019 Oct 7;25(37):5676-5686. doi: 10.3748/wjg.v25.i37.5676.
PubMed 31602167Malik TF, Aurelio DM. Extraintestinal Manifestations of Inflammatory Bowel Disease. 2023 Mar 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK568797/
PubMed 33760556