Unique ID issued by UMIN | UMIN000006192 |
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Receipt number | R000007317 |
Scientific Title | Oral choline tolerance test for nonalcoholic steatohepatitis as non-invasive diagnostic method |
Date of disclosure of the study information | 2011/08/18 |
Last modified on | 2012/07/08 10:57:18 |
Oral choline tolerance test for nonalcoholic steatohepatitis as non-invasive diagnostic method
Oral choline tolerance test for nonalcoholic steatohepatitis
Oral choline tolerance test for nonalcoholic steatohepatitis as non-invasive diagnostic method
Oral choline tolerance test for nonalcoholic steatohepatitis
Japan |
patients with nonalcoholic fatty liver disease
Hepato-biliary-pancreatic medicine |
Others
NO
Although a liver biopsy is presently recognized as the only reliable method of strictly distinguishing nonalcoholic steatohepatitis (NASH) from simple steatosis, this procedure is generally very invasive, expensive and may result in a sampling error.Thus, a non-invasive method for the diagnosis of NASH is needed. In the present study, we evaluate the utility and safety of the oral choline tolerance test for the diagnosis of NASH as an non-invasive method.
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Comparison of the plasma free choline levels of fasting and 1-h to 4-h samples with the diagnosis obtained by the liver biopsy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Diagnosis
Medicine |
The subjects received the oral administration ofcholine (260 mg) under fasting conditions over 12 hours, following that 1-h to 4-h samples (plasma) are obtained.
20 | years-old | <= |
Not applicable |
Male and Female
a.Obtaining informed consent
b.Diagnosis as nonalcoholic fatty liver disease
a.HBs Ag(+) or HCV Ab(+)
b.AMA(+)
c.Alcohol consumption more than 20 g ethanol/day.
d.The patient who has possibility of other liver diseases
e.Woman who are pregnant or with a possibility of pregnancy
f.Renal dysfunction
g.Heart failure
h.Drug allergy
i.Inadequate ot entry to this study
50
1st name | |
Middle name | |
Last name | Atsushi Nakajima |
Yokohama City University Graduate School of Medicine
Division of Gastroenterology
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
045-787-2640
1st name | |
Middle name | |
Last name | Kento Imajo |
Yokohama City University Graduate School of Medicine
Division of Gastroenterology
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
045-787-2640
Division of Gastroenterology, Yokohama City University Graduate School of Medicine
Japan Science and Technology Agency
Japan
NO
2011 | Year | 08 | Month | 18 | Day |
Unpublished
Completed
2011 | Year | 03 | Month | 30 | Day |
2011 | Year | 04 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
2011 | Year | 08 | Month | 18 | Day |
2012 | Year | 07 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007317
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