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Relationship Between HbA1c and Chronic Glycemia in Patients With Cirrhosis

NCT02389127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-11-07

No results posted yet for this study

Summary

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.

Conditions

  • Cirrhosis
  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Continuous glucose monitor (Dexcom, San Diego, CA)

(Group B) patients with known diabetes and cirrhosis with varying degrees of liver dysfunction will wear a continuous glucose monitor (Dexcom, San Diego, CA) for 2 continuous days during week days and week ends, every 4 weeks for 12 consecutive weeks.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Andres Duarte-Rojo, MD, PhD · University of Arkansas

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-06-01
Completion
2017-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02389127 on ClinicalTrials.gov