Relationships Between Mean Plasma Glucose and HbA1c in Cirrhotic Patients With Hepatogenous Diabetes

Study Overview
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Brief Summary
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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
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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

Official Title
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Relationships Between Mean Plasma Glucose and HbA1c in Compensated and Decompensated Cirrhotic Patients With Hepatogenous Diabetes

Conditions
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Liver Cirrhosis, Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months |