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

National Defense Medical Center, Taiwan210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

210

Conditions

Galactose Single Point (GSP), Residual Liver Function

Interventions

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Subject must fulfill all of the following criteria to be eligible for the study: 1. Male or female with age between 20-80. 2. 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: 1. History of serious allergic reaction to galactose and have galactosemia. 2. History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection. 3. History of diabetes mellitus. 4. Subjects are children or handicapped people. 5. Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.

Outcomes

Primary Outcomes

Blood concentration of galactose

To determine the GSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function

Time frame: Sixty minutes

Data from ClinicalTrials.gov

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