GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver

Conditions
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Galactose Single Point (GSP), Residual Liver Function

Intervention / Treatment
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* Drug: Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must fulfill all of the following criteria to be eligible for the study: Male or female with age between 20-80. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires. Exclusion Criteria: Any of the following criteria will disqualify the subject from participation: History of serious allergic reaction to galactose and have galactosemia. History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection. History of diabetes mellitus. Subjects are children or handicapped people. Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GSP measurement<br>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. | Drug: Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSP, galactose single point (GSP)