Relationship Between HbA1c and Chronic Glycemia in Patients With Cirrhosis: a Pilot Study to Better Characterize and Standardize the Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Level of HbA1c in T2DM and cirrhosis
研究概览
简要总结
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.
详细描述
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. This study is designed as a pilot, observational, cross-sectional (Group A - cirrhotics with no T2DM) and longitudinal study (Group B - cirrhotics with known diabetes). For our first aim (Group A) the diagnostic yield of HbA1c for T2DM will be compared to that of an OGTT. Regarding the second aim (Group B) HbA1c will be compared to glucose reading from a continuous glucose monitor. In both groups, the following study labs will be performed: fructosamine, Complete Blood Count (CBC), liver function tests, chemistry, International Normalized Ratio (INR), and pre albumin. A total of 26 patients per group will be included.
STUDY AIMS
The study will look into three primary aims:
- To determine the level of HbA1c that better corresponds to the diagnosis of T2DM - as determined by an OGTT - in cirrhotic patients with different degrees of liver impairment.
- Will test the hypothesis of lower levels of HbA1c being found in T2DM in patients with decompensated cirrhosis when compared to those with compensated disease.
- To correlate the levels of HbA1c with the average glucose (AG) over a 12-week period in patients with cirrhosis and known T2DM, according to different degrees of liver impairment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •Hemoglobin <10 mg/dL
- •Any transfusional requirement within 3 months before inclusion.
- •High-dose vitamin C
- •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
结局指标
主要结局
Level of HbA1c in T2DM and cirrhosis
时间窗: 12 weeks
Patients with cirrhosis and varying degrees of liver dysfunction but no prior diagnosis of T2DM will have an OGTT performed after overnight fasting (8-12-hours).
次要结局
未报告次要终点