UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048569 |
|---|---|
| Receipt number | R000055339 |
| Scientific Title | A prospective observational study for the diagnosis of fatty deposits and fibrosis in non-alcoholic fatty liver disease with circulating natriuretic peptides |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/10/01 15:55:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective observational study for the diagnosis of non-alcoholic fatty liver disease with circulating natriuretic peptides
Acronym
Diagnosis of non-alcoholic fatty liver disease with circulating natriuretic peptides
Scientific Title
A prospective observational study for the diagnosis of fatty deposits and fibrosis in non-alcoholic fatty liver disease with circulating natriuretic peptides
Scientific Title:Acronym
Diagnosis of non-alcoholic fatty liver disease with circulating natriuretic peptides
Region
| Japan |
Condition
Condition
Non-alcoholic fatty liver disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Natriuretic peptides are endogenous hormones, and decreased in metabolic syndrome with hypertension and lipid/glucose metabolism disorders, suggesting the involvement of relative natriuretic peptide deficiency. In the current study, we will investigate whether plasma natriuretic peptides, ANP, and BNP concentrations can be used as diagnostic markers indicating the progression from fatty liver to steatohepatitis in patients with non-alcoholic fatty liver diseases, which is a metabolic syndrome in the liver.
Basic objectives2
Others
Basic objectives -Others
To investigate whether plasma natriuretic peptides, ANP, and BNP concentrations can be used as diagnostic markers indicating the progression from fatty liver to steatohepatitis in patients with non-alcoholic fatty liver diseases, which is a metabolic syndrome in the liver
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the degree of hepatic steatosis/fibrosis by abdominal ultrasound and plasma ANP or BNP concentration
Key secondary outcomes
1. Comparison of the diagnostic accuracy of liver fibrosis between the conventional scoring system to predict liver fibrosis (Fib-4 index, NAFLD fibrosis score) and plasma ANP or BNP concentration
2. Correlation between the presence or absence of arteriosclerosis diagnosed by ABI (ankle brachial pressure index) and plasma ANP/BNP concentrations
3. Correlation between liver fibrosis, arteriosclerosis, and RAS/fibrosis/inflammatory biomarkers
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with fatty liver in the out-patient clinic or hospitalized at the Department of Gastroenterology, Sapporo Medical University Hospital, and provided written consent.
1. Patients who have already been diagnosed with fatty liver in a medical check-up and are scheduled for an abdominal ultrasound
2. Hospitalized patients who are pointed out with fatty liver by abdominal ultrasound or abdominal CT
3. Patients aged 18 years or older at the time of obtained consent
4. Patients who provided voluntary written consent from the patient or their legal representative after receiving sufficient explanation about participating in this study
Key exclusion criteria
1. Patients with a history diagnosed or treated with heart failure
2. Patients with alcohol intake (ethanol conversion) of 30g/day for males and 20g/day for females
3. Patients diagnosed with liver cirrhosis
4. Patients who have a history of infection or who are treated with hepatitis B or hepatitis C
5. Patients with intrahepatic malignant tumors such as hepatocellular carcinoma
6. Patients with a diagnosis of any malignancy
7. Patients under treatment with steroids, immunosuppressants, anticancer drugs, etc.
8. Patients diagnosed with chronic inflammatory diseases, such as autoimmune hepatitis, inflammatory bowel disease
9. Patients who do not consent to this study
10. Patients who are judged to be inappropriate as research subjects by the research director
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Ichiki |
Organization
Sapporo Medical University
Division name
Department of General Medicine
Zip code
060-8556
Address
S1W16, Chuo-ku, Sapporo City, Hokkaido, JAPAN
TEL
011-611-2111
Ichiki.tomoko@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Ichiki |
Organization
Sapporo Medical University
Division name
Department of General Medicine
Zip code
060-8556
Address
S1W16, Chuo-ku, Sapporo City, Hokkaido, JAPAN
TEL
011-611-2111
Homepage URL
Ichiki.tomoko@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Committee, Sapporo Medical University Hospital
Address
291, S1W16, Chuo-ku, Sapporo City, Hokkaido, JAPAN
Tel
011-611-2111
rskk@sapmed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道公立大学法人札幌医科大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood sampling and abdominal ultrasound (and ABI in hospitalized patients) will be performed in out-patient or hospitalized patients with non-alcoholic fatty liver disease. We will examine whether plasma ANP and BNP levels are associated with the degree of hepatic steatosis/fibrosis by abdominal ultrasound, the conventional scoring system for predicting liver fibrosis, and circulating biomarkers of inflammatory, fibrosis, and renin-angiotensin systems.
Management information
Registered date
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2022 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055339
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
