Clinical trial NCT06328452: Risk Factors and Impact MASLD in Patients With IBD
Official title: Risk Factors and Impact of Metabolic Dysfunction -Associated Steatotic Liver Disease in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Keywords: MASLD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* IBD patients with any of the following conditions will be excluded:

  1. Patients with a history of alcohol or drug abuse
  2. Patients with HCV or HBV infection
  3. Patients with autoimmune liver disease
  4. Hepatic malignancies (primary or secondary)
  5. Pregnant women

Primary outcomes:
measure: Assess the prevalence and risk factors of metabolic dysfunction associated steatotic liver disease among patients attending inflammatory bowel disease outpatient clinic
timeFrame: 3 months from 1st April to 30th June 2024
measure: Effect of metabolic dysfunction associated steatotic liver disease on inflammatory bowel disease course
timeFrame: from 1st April 2024 to 30th June 2025
Secondary outcomes:
measure: Performance of serum steatosis markers in prediction of steatosis
timeFrame: from 1st April 2024 to 30th June 2025
Other outcomes:
Locations:
Study officials:
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