Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
Hepatic Micro RNA Expression In Non Alcoholic Fatty Liver Disease
- Epidemiological study of NAFLD, NASH patients.
- Descriptions of altered miRNA profiles in NAFLD patients especially with fibrosis. -
Explore the role of circulating miRNAs as biomarkers for the early diagnosis and
evaluation of NAFLD patient with fibrosis.
Non-alcoholic fatty liver disease (NAFLD) is defined as the presence of hepatic steatosis
(>5%-10% of hepatocytes are fatty) in people without history of excessive alcohol consumption
(>21 drinks/week in men and > 14drinks/week in women) and other disease etiologies that
result in fatty liver.
The presence of coexisting risk factors such as diabetes, metabolic syndrome, and obesity
increases the risk of NAFLD. As a consequence of obesity pandemic and type 2 diabetes, an
increased number of patients with NASH-the most severe form of NAFLD-is expected in the near
future.
According to the latest epidemiological studies, the prevalence of NAFLD is approximately 25%
worldwide.
In developed countries such as the United States, the prevalence of NAFLD is 30%. In
developing countries such as China, the prevalence has reached up to 32.9%.
NAFLD comprises a spectrum of pathological conditions, Including simple steatosis (NAFL),
nonalcoholic steatohepatitis (NASH), fibrosis, cirrhosis and hepatocellular carcinoma (HCC).
Studies have shown that approximately one-sixth of NAFL patients progress to NASH, and 20% of
NASH patients can develop cirrhosis.
The traditional view suggests that HCC formation is a multi-stage process, involving
inflammation, fibrosis and cirrhosis. However, recent research found that NASH can progress
to HCC without fibrosis and cirrhosis.
NAFLD patients are often associated with higher risk of developing both cardiovascular
disease and type 2diabetes, therefore early diagnosis of NAFLD and intervention would greatly
benefit the patient by preventing the progression of major hepatic and extra hepatic
manifestations.
In patients with NAFLD, the most important factor is the assessment of fibrosis severity and
monitoring fibrosis progression. Most patients remain asymptomatic until their liver
functionis compromised.
Thus, the identification of the presence and severity of liver fibrosis remains a clinical
challenge.
Therefore, early predictors need to be investigated.
Multiple factors are involved in NAFLD development, including lipotoxicity, insulin
resistance, endoplasmic reticulum stress, adipose tissue, gut microbiota, and genetics [9].
Our understanding of the pathogenesis of this disease remains limited because of its broad
range and complexity.
Liver biopsy is the current gold standard in diagnosis and prognosis; nevertheless, it is an
expensive and invasive procedure with high sampling error and risk of complications including
pain bleeding; and, in very rare cases, death.
A biomarker is a patient characteristic assessed as an indicator of a normal or a pathologic
process or of a biological response to treatment.
Unfortunately, to date, existing non- or minimally invasive biomarkers are inadequate.
Circulating extracellular vesicles (exosomes and ectosomes) contain various cellular
molecules such as proteins, mRNA, miRNAs, and DNA can serve as biomarkers in NAFLD and NASH.
MicroRNAs (miRNAs) are short, non-coding single stranded RNAs strand of 20-25 nucleotides.
miRNAs play complicated and important roles in regulating the expression of downstream genes
.
MiRNAs contribute to the pathogenesis of NAFLD/NASH at various levels of disease development
and progression and probably are the most extensively studied epigenetic modifications in
NAFLD .
miR-122 is the most abundant miRNA in human liver, representing more than 70% of the total
liver miRNA pool.
During hepatocytes maturation, miR-122 stimulates the expression of 24 hepatocytes-specific
genes, including hepatocyte nuclear factor 6 (HNF6) [13], and in liver regeneration it has
been reported to regulate hepatocytes proliferation and differentiation, recapitulating the
developmental processes.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05480696 -
Soluble Fibre Supplementation in NAFLD
|
Phase 1 | |
Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
Completed |
NCT04671186 -
Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
|
N/A | |
Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
Recruiting |
NCT05462353 -
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
|
Phase 2 | |
Completed |
NCT05006885 -
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
|
Phase 1 | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Recruiting |
NCT04365855 -
The Olmsted NAFLD Epidemiology Study (TONES)
|
N/A | |
Recruiting |
NCT05618626 -
Prevention of NAFLD and CVD Through Lifestyle Intervention
|
N/A | |
Completed |
NCT03256526 -
6-week Safety and PD Study in Adults With NAFLD
|
Phase 2 | |
Enrolling by invitation |
NCT06152991 -
Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy
|
Phase 3 | |
Completed |
NCT03681457 -
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
|
Phase 1 | |
Completed |
NCT06244550 -
Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors
|
N/A | |
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Completed |
NCT03060694 -
Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
|
||
Completed |
NCT02526732 -
Hepatic Inflammation and Physical Performance in Patients With NASH
|
N/A | |
Recruiting |
NCT01988441 -
The Influence of Autophagy on Fatty Liver
|
||
Recruiting |
NCT01680003 -
Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
Completed |
NCT01712711 -
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
Recruiting |
NCT00941642 -
Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
|
Phase 4 |