Urinary Metabonomics of Two Major Patterns of NAFLD

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title: Urinary Metabonomics of Two Major Patterns of NAFLD

Status Recruiting

Clinical Trial Summary

NAFLD(non-alcoholic fatty liver disease, NAFLD) is a common liver disease with a high morbidity which seriously influence people's health. In clinical, there are two major Traditional chinese medicine(TCM) patterns which are the pattern of "liver depression and spleen deficiency" and pattern of "damp-heat in the interior", According to TCM patterns, the treatment is effective, but not used worldwide. While the development of metabonomics provides a tool to investigate the correlation of TCM patterns and metabonomics which will promote the further development of TCM.

Currently researches on NAFLD patterns based on metabolomics were limited. Our study was undertaken to investigate the correlation of TCM patterns and metabonomics, to evaluate the application of urinary metabonomics in NAFLD: whether it can be used in TCM patterns auxiliary classification of NAFLD. In addition, the investigators also aim to discover novel biomarkers for the noninvasive early diagnosis of nonalcoholic fatty liver disease (NAFLD).

In this study, urine samples from humans of three divided groups (healthy controls, the group of "liver depression and spleen deficiency" pattern and group of "damp-heat in the interior pattern) were collected, then 4℃, 15 min 3000 rpm centrifuged and - 80℃ cryopreserved. The metabolic profile changes were analyzed by Gas Chromatograph-Mass Spectrometer(GC/MS) with principal component analysis (PCA), partial least squares-discriminate analysis (PLS-DA) and orthogonal partial least squares-discriminate analysis (OPLS-DA). Furthermore, biochemical examination were also carried out to compare among these three groups.

Base on literature survey, the investigators inferred that there should be metabolic differences between the two patterns of NAFLD. If the investigators hypothesis is correct, the investigators can find different metabolites which can be used discriminate between NAFLD and healthy population, different patterns through urinary metabonomics.

The results will be attractive which mean a lot: it will prove the importance of the four diagnosis methods of TCM used in differential analysis by metabonomics; it will validate the classification of TCM syndromes is scientific; it will shed light in the study of TCM syndromes; it will find biology markers to help diagnosis, treatment and pattern discrimination.

Clinical Trial Description

1. Both genders between the ages of 18-60 years, eligible for study through a screening test confirming the presence of NAFLD according to diagnostic criteria.

2. The patients will fill in a syndromes questionnaire for TCM information.

3. Based on the symptoms, tongue and pulse conditions by four diagnostic information, the NAFLD patients will be randomized into the group of "liver depression and spleen deficiency" pattern and group of "damp-heat in the interior" pattern.

4. Then urine samples of the patients will be collected. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

• NCT number: NCT02077283
• Study type: Observational [Patient Registry]
• Source: ShuGuang Hospital
• Contact: mingyu Sun, PhD
• Phone: 86-21-20256526
• Email: mysun369@126.com
• Status: Recruiting
• Phase: N/A
• Start date: January 2014
• Completion date: November 2017