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

NCT ID: NCT04828512

Last Updated: 2021-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1015 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-02

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Kang SH, Kim MY, Han SK, Baik SK. Subclinical diabetes confirmed by 75-g OGTT influence on the prognosis of decompensated cirrhosis. J Gastroenterol Hepatol. 2024 Jan;39(1):172-179. doi: 10.1111/jgh.16327. Epub 2023 Sep 11.

Reference Type DERIVED
PMID: 37697655 (View on PubMed)

Other Identifiers

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CR 313032

Identifier Type: -

Identifier Source: org_study_id

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