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Subclinical Diabetes Confirmed by 75gm-OGTT Influence on the Prognosis of Decompensated Cirrhosis

Sponsor
Yonsei University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04828512
Collaborator
(none)
1,015
Enrollment
179.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Disorders of glucose metabolism, such as impaired glucose intolerance (IGT) and diabetes mellitus (DM), frequently occur in cirrhosis. However, it has been underestimated when fasting plasma glucose (FPG) levels are considered. We aimed to evaluate who needs to be undertaken a 75-g oral glucose tolerance test (OGTT) to find underlying subclinical diabetes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1015 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Subclinical Diabetes Confirmed by 75gm-OGTT Influence on the Prognosis of Decompensated Cirrhosis
    Actual Study Start Date :
    Jan 2, 2007
    Actual Primary Completion Date :
    Jan 30, 2014
    Anticipated Study Completion Date :
    Dec 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    normal glucose tolerance (NGT)

    In the 75-g OGTT, an FPG level of < 100 mg/dL or a 120-min PG level of < 140 was diagnosed as NGT.
    impaired glucose intolerance (IGT)

    In the 75-g OGTT, an FPG level of 100-125 mg/dL (5.6-6.9 mmol/L) or a 120-min PG level of 140-200 mg/dL (7.8-11.1 mmol/L) was diagnosed as IGT.
    newly diagnosed DM (subclinical DM)

    In the 75-g OGTT, a basal FPG level ˃126 mg/dL (7.0 mmol/L) or a 120-min PG level ˃200 mg/dL (11.1 mmol/L) was considered as newly diagnosed DM (hereafter referred to as subclinical DM).

    Outcome Measures

    Primary Outcome Measures

    1. Survival [through study completion, an average of 3 year]

      Overall survival

    Secondary Outcome Measures

    1. major complications of cirrhosis [through study completion, an average of 3 year]

      hepatic encephalopathy (HE), the development of spontaneous bacterial peritonitis (SBP), acute kidney injury (AKI), variceal bleeding, and infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Liver cirrhosis

    • Admitted to a hospital

    Exclusion Criteria:

    • Previously confirmed DM

    • Being treated for DM

    • Standard risk factors of T2DM, such as high body mass index and family history of diabetes

    • Symptoms of DM, such as increased thirst and the need to urinate

    • Either hepatocellular carcinoma or other malignancy

    • Hepatic failure or uncontrolled decompensation [that is, refractory ascites or active variceal hemorrhage]

    • Significant illnesses such as sepsis that may have interfered with glucose metabolism

    • Pancreatic dysfunction such as acute/chronic pancreatitis that may have affected glucose metabolism.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04828512
    Other Study ID Numbers:
    • CR 313032
    First Posted:
    Apr 2, 2021
    Last Update Posted:
    Apr 2, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Fibrosis

    Study Results

    No Results Posted as of Apr 2, 2021