Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-02 @ 8:02 AM
Study NCT ID:
NCT03487068
Status:
UNKNOWN
Last Update Posted:
2018-04-04
First Post:
2018-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Assess the renal changes in patients with non-alcoholic fatty liver (NAFLD).
Detailed Description:
* Non-alcoholic fatty liver disease (NAFLD) is the accumulation of fat (\>5%) in liver cells in the absence of excessive alcohol intake or other causes of liver disease. The histologic spectrum of NAFLD ranges from simple steatosis to non-alcoholic steatohepatitis (NASH), liver fibrosis, and cirrhosis. This disease affects up to 30% of the general population in Western countries, especially in patients with metabolic syndrome, obesity, and type II diabetes.
* Accumulating epidemiologic evidence indicates that NAFLD not only affects the liver but also increases the risk of extra-hepatic diseases such as type 2 diabetes mellitus, metabolic syndrome, hypertension, cardiovascular or cerebrovascular diseases, and chronic kidney disease.
* Chronic kidney disease (CKD) is defined by decreased estimated glomerular filtration rate (eGFR) and/or the presence of significant proteinuria. Its prevalence is \~ 4.3 - 13% in general population, but it is expected to increase and \~ 50% of these patients develop end-stage renal disease. Recently, CKD is significantly higher in patients with NAFLD than patients without.
* Several studies have demonstrated that NAFLD independently contributes to increasing the risk of CKD where NAFLD and CKD may share many common cardio-metabolic risk factors e.g. insulin resistance, chronic inflammation, and obesity.
* The exact pathophysiologic mechanisms linking NAFLD to CKD are not completely understood, however, there is increased production of various proinflammatory cytokines, reactive oxygen species, TNF-α, C-reactive protein (CRP), and IL-6 by hepatocytes and non-parenchymal cells (Kupffer cells and hepatic stellate cells) that can link NAFLD and CKD. In addition, altered rennin-angiotensin system activation can be involved.
* Several western studies had evaluated the relationship between NAFLD and CKD and shown the prevalence of CKD in NAFLD patients between 4 - 40%.
* An analysis of the United Network Organ Sharing (UNOS) data base during the years (2002-2011) revealed that 35% of the patients transplanted for NAFLD-related cirrhosis progressed to stage 3-4 CKD within 2 years after liver transplantation in comparison to 10% of patients transplanted for other etiologies.
* Despite these findings CKDs often goes unrecognized and The Third National Health and Nutrition survey (NHANESIII), among all individuals with moderately decreased GFR (less than 60ml/min; stage 3) reported the awareness was approximately 8%.
* There is still very little prospective studies and data linking NAFLD to CKD, and it is lacking in the middle east region.
* Accumulating epidemiologic evidence indicates that NAFLD not only affects the liver but also increases the risk of extra-hepatic diseases such as type 2 diabetes mellitus, metabolic syndrome, hypertension, cardiovascular or cerebrovascular diseases, and chronic kidney disease.
* Chronic kidney disease (CKD) is defined by decreased estimated glomerular filtration rate (eGFR) and/or the presence of significant proteinuria. Its prevalence is \~ 4.3 - 13% in general population, but it is expected to increase and \~ 50% of these patients develop end-stage renal disease. Recently, CKD is significantly higher in patients with NAFLD than patients without.
* Several studies have demonstrated that NAFLD independently contributes to increasing the risk of CKD where NAFLD and CKD may share many common cardio-metabolic risk factors e.g. insulin resistance, chronic inflammation, and obesity.
* The exact pathophysiologic mechanisms linking NAFLD to CKD are not completely understood, however, there is increased production of various proinflammatory cytokines, reactive oxygen species, TNF-α, C-reactive protein (CRP), and IL-6 by hepatocytes and non-parenchymal cells (Kupffer cells and hepatic stellate cells) that can link NAFLD and CKD. In addition, altered rennin-angiotensin system activation can be involved.
* Several western studies had evaluated the relationship between NAFLD and CKD and shown the prevalence of CKD in NAFLD patients between 4 - 40%.
* An analysis of the United Network Organ Sharing (UNOS) data base during the years (2002-2011) revealed that 35% of the patients transplanted for NAFLD-related cirrhosis progressed to stage 3-4 CKD within 2 years after liver transplantation in comparison to 10% of patients transplanted for other etiologies.
* Despite these findings CKDs often goes unrecognized and The Third National Health and Nutrition survey (NHANESIII), among all individuals with moderately decreased GFR (less than 60ml/min; stage 3) reported the awareness was approximately 8%.
* There is still very little prospective studies and data linking NAFLD to CKD, and it is lacking in the middle east region.
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?: