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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04546022

Acronym

GSP

Enrollment

210

Registered

2020-09-11

Start date

2007-07-05

Completion date

2018-10-31

Last updated

2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Galactose Single Point (GSP), Residual Liver Function

Keywords

GSP, galactose single point (GSP)

Brief summary

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

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.

Interventions

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood concentration of galactose	Sixty minutes	To determine the GSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026