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OpenTrials
Completed

NCT Number: NCT04546022

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

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.

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Key information

Conditions

Galactose Single Point (GSP), Residual Liver Function Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pseudohypoparathyroidism

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Blood concentration of galactose

    Time frame: Sixty minutes

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

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Collaborators

  • Cardinal Tien Hospital
  • Tri-Service General Hospital (TSGH)

Registry information

Acronym: GSP

Important dates

Study start
2007
Primary completion
2007
Study completion
2018
First posted
Sep 11, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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