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NCT02389127 · ClinicalTrials.gov registry record
Relationship Between HbA1c and Chronic Glycemia in Patients With Cirrhosis
A clinical trial, sponsored by University of Arkansas.
- Completed
- Registry status
- 50
- Enrollment target
NCT02389127: Completed study, sponsored by University of Arkansas.
NCT02389127 is a clinical trial that has completed, run by University of Arkansas. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02389127 has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
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.
Primary Outcome
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).
Interventions
- DEVICE Continuous glucose monitor (Dexcom, San Diego, CA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-07 |
| Est. Completion | 2017-06-01 |
What the finished NCT02389127 record still lists
NCT02389127 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Continuous glucose monitor (Dexcom, San Diego, CA) is the first listed.
NCT02389127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02389127 about?
NCT02389127 is a clinical study titled "Relationship Between HbA1c and Chronic Glycemia in Patients With Cirrhosis". 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 patient...
What is the current status of trial NCT02389127?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2015-07. Estimated completion is 2017-06-01.
What interventions are being tested in trial NCT02389127?
The interventions under investigation include: Continuous glucose monitor (Dexcom, San Diego, CA) (DEVICE).
Who is sponsoring clinical trial NCT02389127?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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