Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588712
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Nutritional Assessment in Individuals with Liver Cirrhosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nutritional Assessment in Individuals with Liver Cirrhosis Nutri-CIRR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nutri-CIRR
Brief Summary:
The risk factors for liver cirrhosis are well identified and primarily include excessive and prolonged alcohol consumption as well as metabolic syndrome or infection with hepatitis B and C viruses However the factors that can predict the progression of the disease are still largely unknown The role of nutritional factors in particular has been insufficiently studied in chronic liver diseases such as cirrhosis Beyond malnutrition and nutritional deficiencies whose roles have been well studied it appears that other nutritional factors such as adherence to dietary recommendations that consider the consumption of various food groups have been little studied in patients with liver cirrhosis Studies involving a large number of participants are essential to better describe the typical nutritional profiles of these patients taking into account their diet as well as their alcohol consumption and physical activity
Therefore the main aim of the Nutri-CIRR project is to identify and characterize typical profiles of patients with hepatic cirrhosis in terms of nutritional factors diet alcohol consumption and physical activity and smoking status
Therefore the main aim of the Nutri-CIRR project is to identify and characterize typical profiles of patients with hepatic cirrhosis in terms of nutritional factors diet alcohol consumption and physical activity and smoking status
Detailed Description:
The Nutri-CIRR study is an observational study taking place in France and assessing nutritional factors among patients with liver cirrhosis After inclusion in the study all patients are invited to complete validated online questionnaires on diet alcohol consumption physical activity as well as socioeconomic and other lifestyle characteristics Questionnaires are completed at one occasion
The main aim of the Nutri-CIRR project is to identify and characterize typical profiles of patients with hepatic cirrhosis in terms of nutritional factors diet alcohol consumption and physical activity and smoking status
Secondary aims are
Secondary aim 1 To describe values of the PNNS-GS2 score categorized into quantiles which takes into account nutritional factors diet alcohol consumption and physical activity
Secondary aim 2 To evaluate the associations between nutritional factors diet alcohol consumption physical activity and the subsequent occurrence of hepatocellular carcinoma
Secondary aim 3 To determine whether nutritional factors diet alcohol consumption physical activity are associated with competing hepatic risks ascites jaundice bleeding due to portal hypertension severe bacterial infections and extra-hepatic risks cardiovascular events extra-hepatic cancers
To address secondary aims 2 and 3 data from the Nutri-CIRR study will be matched with data from the FASTRAK study NCT05095714 which monitors the liver disease progression
The main aim of the Nutri-CIRR project is to identify and characterize typical profiles of patients with hepatic cirrhosis in terms of nutritional factors diet alcohol consumption and physical activity and smoking status
Secondary aims are
Secondary aim 1 To describe values of the PNNS-GS2 score categorized into quantiles which takes into account nutritional factors diet alcohol consumption and physical activity
Secondary aim 2 To evaluate the associations between nutritional factors diet alcohol consumption physical activity and the subsequent occurrence of hepatocellular carcinoma
Secondary aim 3 To determine whether nutritional factors diet alcohol consumption physical activity are associated with competing hepatic risks ascites jaundice bleeding due to portal hypertension severe bacterial infections and extra-hepatic risks cardiovascular events extra-hepatic cancers
To address secondary aims 2 and 3 data from the Nutri-CIRR study will be matched with data from the FASTRAK study NCT05095714 which monitors the liver disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None