Liver CirrhosisNCT02325622
Relationships Between Mean Plasma Glucose and HbA1c in Cirrhotic Patients With Hepatogenous Diabetes
An observational study of Liver Cirrhosis and Diabetes Mellitus, run by Yonsei University at 1 site in South Korea.
Trial summary
The liver plays a crucial role in physiological glycemic control through its involvement in several glucose metabolism processes, including glycogenogenesis and glycogenolysis. Liver diseases result in impaired glucose metabolism due to hepatocyte dysfunction, termed as "hepatogenous diabetes". Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Liver Cirrhosis, Diabetes Mellitus
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Feb 2017
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: liver cirrhosis diagnosed after combining clinical symptoms (thrombocytopenia, gastric/esophageal varices, ascites), histologic studies, and imaging studies (ultrasound, Fibroscan)
Who may be able to join
- Liver cirrhosis
- Age greater than 20 years and less than 70 years
- Diabetes mellitus that occurred after the diagnosis of liver cirrhosis
- Diagnostic criteria for diabetes mellitus
- Fasting plasma glucose ≥ 126 mg/dL
- 2-hour plasma glucose ≥ 200 mg/dL after 75-g OGTT
- Able to consent to study participation (either by the patient him/herself or by legal guardian)
Who cannot join
- Patients in shock requiring vasopressors
- Patients with heart or respiratory failure
- Patients with uncontrolled infection (such as spontaneous bacterial peritonitis)
- Patients with acute renal failure due to medication or renal causes
- Hemoglobin ≤ 10mg/dl
- Patients using insulin, steroid, or beta-blockers
Show all 11Show fewer
- History of hepatocellular carcinoma or other malignancies, or history of diagnosed malignancy that has not been completely remitted
- Patients with medical or psychiatric problems that disables them from performing clinical trial
- Pregnant or lactating women
- Patients unable to comply to trial plan or follow-up monitoring
- Patients deemed by the investigator(s) to be inappropriate for study participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Wonju Severance Cristian Hospital
Wŏnju, Gangwon-do, 220-701
Moon Young Kim, MD,PhD, 82-33-741-1225, drkimmy@yonsei.ac.kr
Moon Young Kim, MD,PhD
About this study
Official title: Relationships Between Mean Plasma Glucose and HbA1c in Compensated and Decompensated Cirrhotic Patients With Hepatogenous Diabetes
The liver plays a crucial role in physiological glycemic control through its involvement in several glucose metabolism processes, including glycogenogenesis and glycogenolysis. Liver diseases result in impaired glucose metabolism due to hepatocyte dysfunction, termed as "hepatogenous diabetes". Abnormal glucose metabolism is found in over 90% of patients with liver cirrhosis. and clinically significant diabetes is known to occur in 30% to 70% of the patients.
A cohort study of cirrhotic patients with hepatogenous diabetes reported a relatively low diabetic complication rate, and the majority of mortality causes were complications related to liver cirrhosis; furthermore, mortality rate due to diabetic complications were reported to be low. Nonetheless, the average survival rate following the diagnosis of liver cirrhosis is rising due to increasing early detection rate and improvements in treatment modalities, and such rise in survival is expected to result in increased prevalence of hepatogenous diabetes and its complications. Therefore, it is necessary to formulate an accurate diagnosis of hepatogenous and to provide appropriate treatment.
Read more
Analyses of the Diabetes Control and Complications Trial (DCCT) demonstrated an association between glycated hemoglobin (HbA1c) and mean plasma glucose concentration in diabetic patients, and currently, HbA1c is being employed as an appropriate marker in diagnosing diabetes mellitus and in monitoring the control of mean blood glucose.
The association between mean plasma glucose concentration and HbA1c in cirrhotic patients has not been clearly established as of yet; however, HbA1c in cirrhotic patients is expected to be influenced by various factors resulted by liver cirrhosis and splenomegaly, including rapid erythrocyte turnover rate and other glycation processes.
Therefore, HbA1c may not be an appropriate indicator in the diagnosis of hepatogenous diabetes or the monitoring of glycemic control; however, no systemic study on this issue has been performed so far. Therefore, the investigators are aiming to investigate the association between mean plasma glucose concentration and HbA1c in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes.
Read the detailed description
- Primary end outcome Association between mean plasma glucose concentration and glycated hemoglobin in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes
- Secondary end outcome
- HbA1c distribution in patients diagnosed with hepatogenous diabetes confirmed by 75-gram oral glucose tolerance test (OGTT)
- Association between mean preprandial blood glucose concentration and glycated hemoglobin in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes
- Association between mean postprandial blood glucose concentration and glycated hemoglobin in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes
- Association between mean plasma glucose concentration and glycated hemoglobin according to Child-pugh's classification and liver stiffness severity
- Factors contributing to discrepancy between mean plasma glucose concentration and HbA1c in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes
- Conditions
- Liver Cirrhosis, Diabetes Mellitus
- Medical subject headings
- Liver Cirrhosis, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between mean plasma glucose concentration and glycated hemoglobin in cirrhosis
The patient choose 3 days within each month, during which they shall check blood glucose level 7 times daily (fasting and 2-hour postprandial glucose for each meal plus bedtime glucose). This shall be done for 3 months.
The study shall be concluded after laboratory studies, including glycated hemoglobin, after 3 months.
Safety assessment :
The subjects shall be educated on hypoglycemic symptoms, checking blood glucose upon onset of hypoglycemia, and immediate food intake. They shall also be instructed to report such events immediately by phone. The cause of hypoglycemia shall be evaluated, and the medications shall be adjusted.
Efficacy assessment :
To assess the primary outcome, the mean plasma glucose shall be calculated by first obtaining the mean of self-monitored blood glucose across 3 days every month and then by adding 11% of the value to the mean- this shall be compared with glycated hemoglobin level measured at 3 months after baseline to check for association.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moon Young Kim, Yonsei University
- Investigators
- Moon Young Kim, MD. PhD, Principal investigator, Department of Internal Medicine, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325622
- Sponsor's protocol ID
- A1C-2014
- Status last verified
- Dec 2014
- First submitted
- 16 Dec 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rohlfing CL, Wiedmeyer HM, Little RR, England JD, Tennill A, Goldstein DE. Defining the relationship between plasma glucose and HbA(1c): analysis of glucose profiles and HbA(1c) in the Diabetes Control and Complications Trial. Diabetes Care. 2002 Feb;25(2):275-8. doi: 10.2337/diacare.25.2.275.
PubMed 11815495Kilpatrick ES, Rigby AS, Atkin SL. Variability in the relationship between mean plasma glucose and HbA1c: implications for the assessment of glycemic control. Clin Chem. 2007 May;53(5):897-901. doi: 10.1373/clinchem.2006.079756. Epub 2007 Mar 23.
PubMed 17384010Koga M, Kasayama S, Kanehara H, Bando Y. CLD (chronic liver diseases)-HbA1C as a suitable indicator for estimation of mean plasma glucose in patients with chronic liver diseases. Diabetes Res Clin Pract. 2008 Aug;81(2):258-62. doi: 10.1016/j.diabres.2008.04.012. Epub 2008 Jun 2.
PubMed 18513821Bando Y, Kanehara H, Toya D, Tanaka N, Kasayama S, Koga M. Association of serum glycated albumin to haemoglobin A1C ratio with hepatic function tests in patients with chronic liver disease. Ann Clin Biochem. 2009 Sep;46(Pt 5):368-72. doi: 10.1258/acb.2009.008231. Epub 2009 Aug 12.
PubMed 19675058Lahousen T, Hegenbarth K, Ille R, Lipp RW, Krause R, Little RR, Schnedl WJ. Determination of glycated hemoglobin in patients with advanced liver disease. World J Gastroenterol. 2004 Aug 1;10(15):2284-6. doi: 10.3748/wjg.v10.i15.2284.
PubMed 15259084
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Mean Plasma Glucose and HbA1c in Compensated and Decompensated Cirrhotic Patients With Hepatogenous Diabetes
- ClinicalTrials.gov ID
- NCT02325622
- Acronym / sponsor ID
- A1C-2014
- Conditions
- Liver Cirrhosis, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 25 Dec 2014 (estimated)
- 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.
The liver plays a crucial role in physiological glycemic control through its involvement in several glucose metabolism processes, including glycogenogenesis and glycogenolysis. Liver diseases result in impaired glucose metabolism due to hepatocyte dysfunction, termed as "hepatogenous diabetes". Abnormal glucose metabolism is found in over 90% of patients with liver cirrhosis. and clinically significant diabetes is known to occur in 30% to 70% of the patients.
A cohort study of cirrhotic patients with hepatogenous diabetes reported a relatively low diabetic complication rate, and the majority of mortality causes were complications related to liver cirrhosis; furthermore, mortality rate due to diabetic complications were reported to be low. Nonetheless, the average survival rate following the diagnosis of liver cirrhosis is rising due to increasing early detection rate and improvements in treatment modalities, and such rise in survival is expected to result in increased prevalence of hepatogenous diabetes and its complications. Therefore, it is necessary to formulate an accurate diagnosis of hepatogenous and to provide appropriate treatment.
Analyses of the Diabetes Control and Complications Trial (DCCT) demonstrated an association between glycated hemoglobin (HbA1c) and mean plasma glucose concentration in diabetic patients, and currently, HbA1c is being employed as an appropriate marker in diagnosing diabetes mellitus and in monitoring the control of mean blood glucose.
The association between mean plasma glucose concentration and HbA1c in cirrhotic patients has not been clearly established as of yet; however, HbA1c in cirrhotic patients is expected to be influenced by various factors resulted by liver cirrhosis and splenomegaly, including rapid erythrocyte turnover rate and other glycation processes.
Therefore, HbA1c may not be an appropriate indicator in the diagnosis of hepatogenous diabetes or the monitoring of glycemic control; however, no systemic study on this issue has been performed so far. Therefore, the investigators are aiming to investigate the association between mean plasma glucose concentration and HbA1c in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes.
Detailed description
- Primary end outcome Association between mean plasma glucose concentration and glycated hemoglobin in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes
- Secondary end outcome
- HbA1c distribution in patients diagnosed with hepatogenous diabetes confirmed by 75-gram oral glucose tolerance test (OGTT)
- Association between mean preprandial blood glucose concentration and glycated hemoglobin in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes
- Association between mean postprandial blood glucose concentration and glycated hemoglobin in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes
- Association between mean plasma glucose concentration and glycated hemoglobin according to Child-pugh's classification and liver stiffness severity
- Factors contributing to discrepancy between mean plasma glucose concentration and HbA1c in patients with compensated or decompensated liver cirrhosis who also have hepatogenous diabetes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- liver cirrhosis diagnosed after combining clinical symptoms (thrombocytopenia, gastric/esophageal varices, ascites), histologic studies, and imaging studies (ultrasound, Fibroscan)
Key inclusion criteria (7 listed)
- Liver cirrhosis
- Age greater than 20 years and less than 70 years
- Diabetes mellitus that occurred after the diagnosis of liver cirrhosis
- Diagnostic criteria for diabetes mellitus
- Able to consent to study participation (either by the patient him/herself or by legal guardian)
Key exclusion criteria (11 listed)
- Patients in shock requiring vasopressors
- Patients with heart or respiratory failure
- Patients with uncontrolled infection (such as spontaneous bacterial peritonitis)
- Patients with acute renal failure due to medication or renal causes
- Hemoglobin ≤ 10mg/dl
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
Association between mean plasma glucose concentration and glycated hemoglobin in cirrhosis
Time frame: 3 months
The patient choose 3 days within each month, during which they shall check blood glucose level 7 times daily (fasting and 2-hour postprandial glucose for each meal plus bedtime glucose). This shall be done for 3 months. The study shall be concluded after laboratory studies, including glycated hemoglobin, after 3 months. Safety assessment : The subjects shall be educated on hypoglycemic symptoms, checking blood glucose upon onset of hypoglycemia, and immediate food intake. They shall also be instructed to report such events immediately by phone. The cause of hypoglycemia shall be evaluated, and the medications shall be adjusted. Efficacy assessment : To assess the primary outcome, the mean plasma glucose shall be calculated by first obtaining the mean of self-monitored blood glucose across 3 days every month and then by adding 11% of the value to the mean- this shall be compared with glycated hemoglobin level measured at 3 months after baseline to check for association.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2014.
- Background: PubMed 11815495Rohlfing CL, Wiedmeyer HM, Little RR, England JD, Tennill A, Goldstein DE. Defining the relationship between plasma glucose and HbA(1c): analysis of glucose profiles and HbA(1c) in the Diabetes Control and Complications Trial. Diabetes Care. 2002 Feb;25(2):275-8. doi: 10.2337/diacare.25.2.275.
- Background: PubMed 17384010Kilpatrick ES, Rigby AS, Atkin SL. Variability in the relationship between mean plasma glucose and HbA1c: implications for the assessment of glycemic control. Clin Chem. 2007 May;53(5):897-901. doi: 10.1373/clinchem.2006.079756. Epub 2007 Mar 23.
- Background: PubMed 18513821Koga M, Kasayama S, Kanehara H, Bando Y. CLD (chronic liver diseases)-HbA1C as a suitable indicator for estimation of mean plasma glucose in patients with chronic liver diseases. Diabetes Res Clin Pract. 2008 Aug;81(2):258-62. doi: 10.1016/j.diabres.2008.04.012. Epub 2008 Jun 2.
- Background: PubMed 19675058Bando Y, Kanehara H, Toya D, Tanaka N, Kasayama S, Koga M. Association of serum glycated albumin to haemoglobin A1C ratio with hepatic function tests in patients with chronic liver disease. Ann Clin Biochem. 2009 Sep;46(Pt 5):368-72. doi: 10.1258/acb.2009.008231. Epub 2009 Aug 12.
- Background: PubMed 15259084Lahousen T, Hegenbarth K, Ille R, Lipp RW, Krause R, Little RR, Schnedl WJ. Determination of glycated hemoglobin in patients with advanced liver disease. World J Gastroenterol. 2004 Aug 1;10(15):2284-6. doi: 10.3748/wjg.v10.i15.2284.
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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.
Moon Young Kim, MD. PhD principal investigator
Department of Internal Medicine, Wonju Severance Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Diabetes Mellitus, run by Yonsei University at 1 site in South Korea.
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 7 inclusion and 11 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 25 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Moon Young Kim, MD. PhD (+82-33-7411229, drkimmy@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between mean plasma glucose concentration and glycated hemoglobin in cirrhosis (time frame: 3 months). 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 NCT02325622, which also lists 5 linked publications.
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 25 Dec 2014.