CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
liver and white adipose tissue biopsiesprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02158351
NCT02158351N/ACompleted

Role and Pathogenetic Mechanisms of Intestinal Microbiota in Non-alcoholic Fatty Liver Disease Severity in Obese and Non-obese Subjects

University of Roma La Sapienza·observational·Posted Jun 6, 2014·Updated Nov 20, 2020

In Brief

An observational study evaluating liver and white adipose tissue biopsies for Simple Steatosis (SS) and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Several experimental data suggest that gut-derived endotoxin and GM composition can act as a "second hit" or insult to convert hepatic SS to NASH and cause both local hepatic and systemic inflammation.This study's aim is to analyze microbiota diversity, providing information both on intestinal microbial composition and on the metabolic processes linked to them. In addition, we will correlate, for the first time, GM composition to hepatic and white adipose tissue gene expression patterns of interest and serum and fecal markers possibly related to impaired fat storage and inflammation. We aim to provide preliminary data to design future intervention studies with pre- or probiotics or bile acid derivatives to prevent/treat inflammation and fibrosis in NAFLD patients.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 6, 2014
Enrollment StartNov 1, 2013
Primary CompletionJun 1, 2014
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.1 years ago

Interventions

liver and white adipose tissue biopsiesprocedure