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| Name | Class |
|---|---|
| Cardinal Tien Hospital | OTHER |
| Tri-Service General Hospital (TSGH) | OTHER |
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The primary objective is to determine the galactose single point (GSP) cutoff values to discriminate subjects with different hepatic function. The secondary objective is to analyze the correlations between GSP and other hepatic function assessment methods among this trial subjects.
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, including the potential for progression to nonalcoholic steatohepatitis (NASH), followed by fibrosis and ultimately cirrhosis. The gold standard to evaluate fibrosis in patients with NAFLD is liver biopsy. The investigators aimed to evaluate the clinical utility of using the galactose single point (GSP) test which recommended by the US FDA to quantitatively measure liver function in patients with NAFLD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSP measurement | Other | For the GSP measurement, subjects will be Intravenous administered with 1.25 ml/kg G.S.P. solution (400 mg/ml of galactose) to subjects after I.V. G.SP. solution within 3 to 5 minutes. Sixty minutes after- G.S.P. solution, a sample of 0.5 ml of whole blood will be taken from subject's finger for the determination of GSP value. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours. | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration of galactose | To determine the GSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function | Sixty minutes |
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Inclusion Criteria:
Subject must fulfill all of the following criteria to be eligible for the study:
Exclusion Criteria:
Any of the following criteria will disqualify the subject from participation:
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| ID | Term |
|---|---|
| D011547 | Pseudohypoparathyroidism |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008664 | Metal Metabolism, Inborn Errors |
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| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |