Liver CirrhosisNCT04828512
Subclinical Diabetes Confirmed by 75gm-OGTT Influence on the Prognosis of Decompensated Cirrhosis
An observational study of Liver Cirrhosis, run by Yonsei University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 1,015 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2007to 30 Dec 2021
- How long will I take part?
- 42 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with cirrhosis without previous diabetes history
Who may be able to join
- Liver cirrhosis
- Admitted to a hospital
Who cannot join
- 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.
About this study
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.
- Conditions
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Overall survival
Measured: through study completion, an average of 3 year
Secondary outcomes (1)
major complications of cirrhosis
hepatic encephalopathy (HE), the development of spontaneous bacterial peritonitis (SBP), acute kidney injury (AKI), variceal bleeding, and infection
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start2 Jan 2007
- Primary completion30 Jan 2014
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,015 participants (actual)
- Target duration
- 42 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828512
- Sponsor's protocol ID
- CR 313032
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37697655
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Diabetes Confirmed by 75gm-OGTT Influence on the Prognosis of Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT04828512
- Acronym / sponsor ID
- CR 313032
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Jan 2007 (actual)
- Primary completion
- 30 Jan 2014 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 42 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cirrhosis without previous diabetes history
Key inclusion criteria (2 listed)
- Liver cirrhosis
- Admitted to a hospital
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: through study completion, an average of 3 year
Overall survival
1 secondary outcome
major complications of cirrhosis
Time frame: through study completion, an average of 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Derived from this study: PubMed 37697655Kang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.