Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315361
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
DIAbetes and NAFLD
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Prevalence and Clinical Impact of Liver Fibrosis Associated With Non-alcoholic Hepatic Steatosis NAFLD in Individuals With Type 2 Diabetes and Relationship With Diabetes Therapies
Status:
ACTIVE_NOT_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:
DIANA
Brief Summary:
Non-alcoholic hepatic steatosis NAFLD is characterised by the excessive accumulation of triglycerides in the liver and is often associated in the absence of significant alcohol consumption with insulin resistance and metabolic syndrome with which it shares the most frequent clinical manifestations hypertension dyslipidaemia visceral adiposity glucose intolerance Due to the pandemic spread of obesity and diabetes and by virtue of better control of viral hepatitis NAFLD is the most common cause of liver damage in Western countries with a prevalence of around 20-30 of the general population
The clinical impact of NAFLD in diabetes 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 to be at higher risk of disease severity
Individuals with diabetes are in fact those at greatest risk of developing the clinical sequelae of NAFLD and often do not receive adequate hepatological support and a correct hepatic pathology In fact it has been documented in the literature that the presence of diabetes increases the severity of liver damage bringing the risk of NASH up to 80 and increasing the risk of significant fibrosis to 30-40 of subjects with hepatic steatosis as well as representing an independent predictor for significant fibrosis Lastly the increased risk of hepatocarcinoma in subjects with diabetes and NAFLD should not be overlooked as documented by our group and confirmed in a large Italian case series
In subjects with diabetes moreover the presence of NAFLD is not only associated with worse glycaemic control but also with micro- and macro-vascular complications as well as nephrological and neuropathic complications and increased mortality
Therefore the possibility of applying the non-invasive fibrosis scores currently available for NAFLD on a large scale in a population at high risk of progressive liver disease would make it possible to characterise a the true epidemiology of significant fibrosis F3 or higher b allow primary prevention actions to be carried out by optimising the use of resources or by identifying subjects at greater risk of damage progression c understand in cases with a long history of disease the true prevalence of clinical outcomes d understand the epidemiology of comorbidities and polypharmacy as a function of significant fibrosis
The clinical impact of NAFLD in diabetes 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 to be at higher risk of disease severity
Individuals with diabetes are in fact those at greatest risk of developing the clinical sequelae of NAFLD and often do not receive adequate hepatological support and a correct hepatic pathology In fact it has been documented in the literature that the presence of diabetes increases the severity of liver damage bringing the risk of NASH up to 80 and increasing the risk of significant fibrosis to 30-40 of subjects with hepatic steatosis as well as representing an independent predictor for significant fibrosis Lastly the increased risk of hepatocarcinoma in subjects with diabetes and NAFLD should not be overlooked as documented by our group and confirmed in a large Italian case series
In subjects with diabetes moreover the presence of NAFLD is not only associated with worse glycaemic control but also with micro- and macro-vascular complications as well as nephrological and neuropathic complications and increased mortality
Therefore the possibility of applying the non-invasive fibrosis scores currently available for NAFLD on a large scale in a population at high risk of progressive liver disease would make it possible to characterise a the true epidemiology of significant fibrosis F3 or higher b allow primary prevention actions to be carried out by optimising the use of resources or by identifying subjects at greater risk of damage progression c understand in cases with a long history of disease the true prevalence of clinical outcomes d understand the epidemiology of comorbidities and polypharmacy as a function of significant fibrosis
Detailed Description:
None
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