Nutritional Assessment in Individuals with Liver Cirrhosis

Официальное название

Nutritional Assessment in Individuals with Liver Cirrhosis (Nutri-CIRR)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Nutritional intakes [Срок оценки: At enrollment]
• Food group intakes [Срок оценки: At enrollment]
• Mediterranean diet score [Срок оценки: At enrollment]
• Alcohol intake [Срок оценки: At enrollment]
• Smoking status [Срок оценки: At enrollment]
• Physical activity [Срок оценки: At enrollment]
• Sedentary behavior [Срок оценки: At enrollment]
• Weight [Срок оценки: At enrollment]
• Height [Срок оценки: At enrollment]
• Body mass index [Срок оценки: At enrollment]

Вторичные конечные точки (5)

• Socioeconomic factors [Срок оценки: At enrollment]
• Demographic factors [Срок оценки: At enrollment]
• Follow-up of cirrhotic disease (occurrence of hepatocellular carcinoma) [Срок оценки: From enrollment to the end of follow-up at 3 years]
• Follow-up of cirrhotic disease (other hepatic complications) [Срок оценки: From enrollment to the end of follow-up at 3 years]
• Follow-up of cirrhotic disease (extra-hepatic complications) [Срок оценки: From enrollment to the end of follow-up at 3 years]

Критерии участия

Критерии включения

• Adult patients
• Histologically proven cirrhosis or unequivocally suggested by non-invasive tests
• No HCC on imaging dated less than 3 months
• Ability to understand and read French, at the investigator\'s discretion
• Affiliation with a social security system

Критерии исключения

• Child-Pugh C score
• Active hepatitis B or C
• Patient under legal protection
• Patient deprived of liberty
• Pregnant or breastfeeding woman, as known by the investigator
• Patient under State Medical Assistance (AME)
• Patient opposed to participating in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06588712 · 2023-A01392-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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