Non-alcoholic Fatty Liver DiseaseNCT02077283
Urinary Metabonomics of Two Major Patterns of NAFLD
An observational study of Non-alcoholic Fatty Liver Disease, run by ShuGuang Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Nov 2017
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All patients will be enrolled in NAFLD outpatient of Shuguang hospital. The healthy people also will be enrolled in Shuguang hospital.
Who may be able to join
- The existence of fat in liver parenchyma scatters the beam of ultrasound more than a non-fatty liver. Although ultrasonography might have some limitations for the grading of NAFLD, its availability makes it an appropriate tool for NAFLD screening.The radiologist was not informed about the clinical.
- NAFLD indicates the lack of any evidence of ongoing or recent consumption of significant quantities of alcohol.
- Both genders between the ages of 18-60 years, eligible for study through a screening test confirming the presence of NAFLD as defined above.
- Based on tongue, pulse conditions and other four diagnostic information, the NAFLD patients who have the symptoms which can be recognized as "liver depression and spleen deficiency" pattern or "damp-heat in the interior" pattern.
Who cannot join
- History of diabetes mellitus or any metabolic disease
- Alcohol consumption > 20 g/day.
- Presently having acute diseases or other untreated illness requiring treatment.
- Impaired hepatic or renal functions.
- Lactation, pregnancy or unwillingness to use an effective form of birth control for women of childbearing years.
- History or presence of any condition, in the investigator's opinion, that would endanger the individual's safety or affect the study result.
- If any of conditions above exists, the subjects were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Liver Disease, ShuGuang Hospital, Shanghai University of TCM.
Shanghai, 201203
mingyu Sun, PhD, 86-21-20256526, mysun369@126.com
About this study
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).
Read more
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.
Read the detailed description
- 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.
- The patients will fill in a syndromes questionnaire for TCM information.
- 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.
- Then urine samples of the patients will be collected.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- NAFLD (non-alcoholic fatty liver disease, NAFLD), urinary metabonomics, TCM pattern, "liver depression and spleen deficiency" pattern,, "damp-heat in the interior" pattern
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy people | This group contains healthy people only whose liver function and B ultrasound are normal. | |
| group of "liver depression and spleen deficiency" pattern | 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. | |
| group of "damp-heat in the interior" pattern. | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Dong, ShuGuang Hospital
- Investigators
- mingyu Sun, PhD, Study director, Institute of Liver Disease, ShuGuang Hospital, Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077283
- Sponsor's protocol ID
- 2013-KYKS-7-01
- Status last verified
- Nov 2015
- First submitted
- 26 Feb 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Metabonomics of Two Major Patterns of NAFLD
- ClinicalTrials.gov ID
- NCT02077283
- Acronym / sponsor ID
- 2013-KYKS-7-01
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- NAFLD (non-alcoholic fatty liver disease, NAFLD), urinary metabonomics, TCM pattern, "liver depression and spleen deficiency" pattern,, "damp-heat in the interior" pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- The patients will fill in a syndromes questionnaire for TCM information.
- 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.
- Then urine samples of the patients will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy people | – | –This group contains healthy people only whose liver function and B ultrasound are normal. |
| group of "liver depression and spleen deficiency" pattern | – | –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. |
| group of "damp-heat in the interior" pattern. | – | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients will be enrolled in NAFLD outpatient of Shuguang hospital. The healthy people also will be enrolled in Shuguang hospital.
Key inclusion criteria (4 listed)
- The existence of fat in liver parenchyma scatters the beam of ultrasound more than a non-fatty liver. Although ultrasonography might have some limitations for the grading of NAFLD, its availability makes it an appropriate tool for NAFLD screening.The radiologist was not informed about the clinical.
- NAFLD indicates the lack of any evidence of ongoing or recent consumption of significant quantities of alcohol.
- Both genders between the ages of 18-60 years, eligible for study through a screening test confirming the presence of NAFLD as defined above.
- Based on tongue, pulse conditions and other four diagnostic information, the NAFLD patients who have the symptoms which can be recognized as "liver depression and spleen deficiency" pattern or "damp-heat in the interior" pattern.
Key exclusion criteria (7 listed)
- History of diabetes mellitus or any metabolic disease
- Alcohol consumption > 20 g/day.
- Presently having acute diseases or other untreated illness requiring treatment.
- Impaired hepatic or renal functions.
- Lactation, pregnancy or unwillingness to use an effective form of birth control for women of childbearing years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
metabolites
Time frame: 5 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mingyu Sun, PhD study director
Institute of Liver Disease, ShuGuang Hospital, Shanghai University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease, run by ShuGuang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mingyu Sun, PhD (86-21-20256526, mysun369@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolites (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.