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

Primary Purpose

Galactose Single Point (GSP), Residual Liver Function

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional screening trial for Galactose Single Point (GSP), Residual Liver Function focused on measuring GSP, galactose single point (GSP)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

GSP measurement

Arm 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.

Outcomes

Primary Outcome Measures

Blood concentration of galactose

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04546022

First Posted

September 6, 2020

Last Updated

September 10, 2020

Sponsor

National Defense Medical Center, Taiwan

Collaborators

Cardinal Tien Hospital, Tri-Service General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04546022

Brief Title

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

Acronym

GSP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

July 5, 2007 (Actual)

Primary Completion Date

August 12, 2007 (Actual)

Study Completion Date

October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Defense Medical Center, Taiwan

Collaborators

Cardinal Tien Hospital, Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Galactose Single Point (GSP), Residual Liver Function

Keywords

GSP, galactose single point (GSP)

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSP measurement

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Blood concentration of galactose

Description

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

Time Frame

Sixty minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

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

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