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

National Defense Medical Center, Taiwan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Galactose Single Point (GSP), Residual Liver Function

Treatments: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT04546022

GSP-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 210 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

GSP measurement

Other group

Description:

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.

Treatment:

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.