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NCT04828512 Clinical Trial

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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04828512
Other study ID # CR 313032
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2, 2007
Est. completion date December 30, 2021

Study information
Verified date March 2021
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1015
Est. completion date December 30, 2021
Est. primary completion date January 30, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Outcome
Type Measure Description Time frame Safety issue
Primary Survival Overall survival through study completion, an average of 3 year
Secondary major complications of cirrhosis hepatic encephalopathy (HE), the development of spontaneous bacterial peritonitis (SBP), acute kidney injury (AKI), variceal bleeding, and infection through study completion, an average of 3 year
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