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

Yonsei University

Status: Unknown

Conditions: Liver Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT04828512

CR 313032

Details and patient eligibility

About

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.

Enrollment: 1,015 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,015 participants in 3 patient groups

normal glucose tolerance (NGT)

Description:

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)

Description:

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)

Description:

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).