Obesity Clinical Trial
Official title:
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
The main aim of the study is to set up an observational cohort with NAFLD (Non-alcoholic
fatty liver disease) at different stage of disease (from simple steatosis to cirrhosis and/or
HCC-Hepatocellular carcinoma) and for comparative purpose a cohort of subjects with diabetes
and/or obesity and/or other risk factors (i.e. psoriasis, IBD (inflammatory bowel disease),
dyslipidemia) without NAFLD in order to have a clinical phenotypical characterization and the
collection of biological specimens.
We will collect clinical data, biological samples and imaging results in order to perform
future cross-sectional studies and/or longitudinal studies for elucidating pathways of the
disease and develop and validate biomarkers for diagnosis, prognosis and monitoring liver
disease and comorbidities in order to contribute to precision medicine in this field.
Non-alcoholic fatty liver disease (NAFLD) is characterized by the excessive accumulation of
triglycerides in the liver and is often associated, in the absence of significant alcohol
consumption, to insulin resistance and to the metabolic syndrome of which it shares the most
frequent clinical manifestations (hypertension, dyslipidemia, visceral adiposity, glucose
intolerance). Because of the pandemic spread of obesity and diabetes and by virtue of the
best control of viral hepatitis, in western countries NAFLD is the most common cause of liver
injury with prevalence that is around 20-30% of the general population.
NAFLD encompasses a broad spectrum of liver conditions associated with fat accumulation that
ranges from benign fatty liver (FL), non-progressive liver fat accumulation to severe liver
injury, cirrhosis, and liver failure. The histological signature ballooning degeneration
(with or without Mallory bodies) and/or inflammation and/or fibrosis is typical of
nonalcoholic steatohepatitis (NASH), that may progress to: i) cirrhosis and contribute to one
category of cryptogenic cirrhosis (CC), in which steatosis may be present or absent; ii)
hepatocellular carcinoma (HCC). Furthermore, the correct indication of subjects with
significant fibrosis in the highest risk populations could also contribute to reducing the
increasing prevalence of cirrhosis secondary to NAFLD as an indication to liver
transplantation. Moreover, the expected impact of NAFLD and its complication on public health
is quite impressive worldwide.
Hepatic steatosis is emerging as an early and common determinant of many of these diseases
and co-morbidities, as reported also by our research group. Fatty liver, in fact, may cause
lipid accumulation, inflammation, and oxidative stress at the hepatic level leading to NAFLD,
and facilitating the occurrence of additional clinical co-morbidities by the activation of
common molecular and cellular mechanisms. In fact, NAFLD is correlated to several metabolic
diseases, such as Metabolic Syndrome (MetS), Cardiovascular Diseases (CVD), Chronic Kidney
Disease (CKD), Hepatocellular carcinoma (HCC), Obstructive sleep apnoea (OSA), Polycystic
ovary syndrome (PCOS) and Chronic Plaque Psoriasis NAFLD is considered the liver
manifestation of metabolic syndrome and beyond effects on the liver (risk of cirrhosis and
HCC), can also increase the risk of morbidity due to CVD, CKD, psoriasis, PCOS, OSA, and
mortality related to T2DM, coronary heart disease, even in absence of well-known risk factors
(i.e. smoking, hypertension, T2DM, dyslipidaemia). In this regard, interventions such as
lifestyle modification (proper nutrition and exercise), along with pharmacological agents are
vital to reduce co-morbidities. Interestingly, the role of the liver seems to be central in
the onset and progression of its co-morbidities. However, there are still insufficient
information regarding the disease pathways and mechanisms common to these disorders
co-occurring with NAFLD.
Within this scenario the appropriate management of NAFLD may have a beneficial effect also on
the co-morbidities. At today, the investigation of the common pathogenic mechanisms of the
abovementioned inter-related diseases has been approached rather ineffectively, leaving major
holes and undermining the development of appropriate management programs for NAFLD/NASH and
its related co-morbidities. In order to fill the gap and increase the quality of data for a
multi-omic approach we decided to set up a certified local repository. Therefore, the
understanding of the pathogenesis of NAFLD and its relevance in the development of related
co-morbidities is crucial to guide the development of future treatments and to inform
European Union health and economic policies. The clinical impact of NAFLD is considerable and
represents a real driver of the major clinical outcomes that impact on the health of the
individual, consequently creating a real burden of disease, especially in those populations
considered at higher risk of fibrosis such as diabetics or obese. The global burden of
NAFLD/NASH and CC require a multi-omic approach in order to prevent and to provide health
plans for avoid implications for the population.
Despite the high epidemiology impact, there are still significant areas of unmet clinical
need in NAFLD: i) the lack of knowledge on molecular mechanism leading to progression of
liver disease; ii) a poor understanding of disease sub-phenotypes; iii) the lack of
biomarkers of disease progression that allow risk stratification.
The current availability of the -omics technologies generating libraries of genome-wide data,
metabolomes, proteomes and microbiome will allow a precision medicine approach in order to
improve the knowledge of disease and to generate a personalized approach to improve the
clinical practice and optimize the public health plans for prevention programs and NAFLD
management.
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