Risk Factors and Impact MASLD in Patients With IBD

NCT06328452 | Not Yet Recruiting

• 1 other identifier: MASLD
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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). 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.

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords

MASLD

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  from 1st April 2024 to 30th June 2025

Secondary Outcomes (1)

• Performance of serum steatosis markers in prediction of steatosis

  from 1st April 2024 to 30th June 2025

Interventions

FibroScan DEVICE

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.

Eligibility Criteria

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

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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

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Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 25, 2024
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share