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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.
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

    First Posted
    September 6, 2020
    Last Updated
    September 10, 2020
    Sponsor
    National Defense Medical Center, Taiwan
    Collaborators
    Cardinal Tien Hospital, Tri-Service General Hospital
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    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
    No
    Studies a U.S. FDA-regulated Device Product
    No
    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
    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.
    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
    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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