Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06328452
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-16
Brief Title:
Risk Factors and Impact MASLD in Patients With IBD
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Risk Factors and Impact of Metabolic Dysfunction -Associated Steatotic Liver Disease in Patients With Inflammatory Bowel Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MASLD
Brief Summary:
Inflammatory bowel disease IBD is a chronic disease characterized by remitting and relapsing inflammation of the gastrointestinal tract Crohns 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 autoimmunegranulomatous hepatitis and non-alcoholic fatty liver disease NAFLD
Metabolic dysfunction-associated steatotic liver disease MASLDformerly 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
In about 5-50 of patients with IBD there are several extraintestinal manifestations as primary sclerosing cholangitis autoimmunegranulomatous hepatitis and non-alcoholic fatty liver disease NAFLD
Metabolic dysfunction-associated steatotic liver disease MASLDformerly 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 Crohns 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 autoimmunegranulomatous 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 253 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
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 autoimmunegranulomatous 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 253 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None