An observational study in Non-alcoholic Fatty Liver Disease, sponsored by ShuGuang Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by ShuGuang Hospital · Observational
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 114 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →ShuGuang Hospital is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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All patients will be enrolled in NAFLD outpatient of Shuguang hospital. The healthy people also will be enrolled in Shuguang hospital.
Exclusion Criteria:
If any of conditions above exists, the subjects were excluded.
This group contains healthy people only whose liver function and B ultrasound are normal.
In this group, patients are considered to be the pattern of "liver depression and spleen deficiency". They mainly have the symptoms of loose stool, depression, fat tongue with white coating and teeth marks and soft or string pulse.
In this group ,NAFLD patients have symptoms with dry mouth, bitter mouth, heavy feeling in legs, yellow urine, reddish tongue with thick yellowish coating and slippery pulse.
metabolites
Urine samples of patients will be collected when they come to outpatient service. Then the urine metabolic profile changes will be analyzed by GC/MS and be manifested through different metabolites.
Time frame: 5 months
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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ShuGuang Hospital