Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT03487068
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.
Study:
NCT03487068
Study Brief:
Protocol Section:
NCT03487068