Relationship Between HbA1c and Chronic Glycemia in Patients With Cirrhosis
Completed
Conditions studied: Cirrhosis, Diabetes Mellitus, Type 2
In brief
Cirrhosis and advanced liver disease have been associated with an increased risk for hyperglycemia and type 2 diabetes mellitus (T2DM). The diagnostic yield of common tests used to define diabetes and insulin resistance in the general population differs significantly from the one observed in patients with liver disease. Glycosylated hemoglobin A1c (HbA1c), a reliable test to assess chronic glycemia and recommended both for the diagnosis and monitoring of T2DM, is neither accurate nor reliable in patients with cirrhosis. A validation study has not been performed to define its true usefulness in the setting of cirrhosis. The study aims to determine the level of HbA1c that better corresponds to the diagnosis of T2DM - as determined by an oral glucose tolerance test (OGTT) - and to correlate the levels of HbA1c with the average glucose over a 12-week period in patients with cirrhosis and known T2DM, in cirrhotic patients with different degrees of liver impairment as compared to patients with T2DM and no liver disease.
Key facts
- Study ID
- NCT02389127
- Run by
- University of Arkansas
- People needed
- 50
- Starts
- 2015-07-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-11-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Group A
- Cirrhosis, either clinically- or biopsy-proven
- Child-Pugh-Turcotte (CTP) A, B, and C (only biopsy-proven in the case of CTP-A)
- Random glucose <200 mg/dL on at least 3 occasions
- No use of insulin or any hypoglycemic agent
- Group B
- Cirrhosis, either clinically- or biopsy-proven
- Child-Pugh-Turcotte (CTP) A, B, and C (only biopsy-proven in the case of CTP-A)
- Prior diagnosis of T2DM as based on any of ADA criteria
- Use of insulin or any hypoglycemic agent
- Control Group
- Age 18 to 75
- No known chronic liver disease
- Prior diagnosis of T2DM as based on any of ADA criteria
- Use of insulin or any hypoglycemic agent
You may not qualify if…
- Hemoglobin <10 mg/dL
- Any transfusional requirement within 3 months before inclusion.
- High-dose vitamin C
- Cr ≥1.3
- Hepatocellular carcinoma (any stage)
- Any splanchnic thrombosis (portal, mesenteric, or splenic)
- Persistent or difficult-to-treat hepatic encephalopathy
- Refractory ascites
- Status post-TIPS
- Status post-liver transplant
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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