Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT04216303|
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment|
|Diabetes Liver Transplant; Complications Kidney Transplant Failure||Diagnostic Test: hemoglobin A1c|
Major cardiovascular events are greatest in liver transplant recipients with sustained post-transplantation diabetes1. However, the optimal A1c target after transplantation has not been studied. The objective is to understand the optimal A1c target post liver and combined liver and kidney transplant. Strict A1c control will improve mortality and cardiovascular risk post liver and combined liver and kidney transplant and improve complications post liver and combined liver and kidney transplant.
Strict blood sugar control in non-transplant patients with diabetes mellitus has shown unfavorable results in previous studies2. However, no optimal A1c level has been studied in liver and combined liver and kidney transplant patients. Furthermore, guidelines for A1c target post-transplant are of expert opinion3.
The primary objective is to assess the impact of hemoglobin A1c on all-cause mortality among patients with diabetes mellitus undergoing liver or combined liver and kidney transplantation between 2008 to 2018. The second objective is to assess the impact of hemoglobin A1c on complications post liver or combined liver and kidney transplantation.
|Study Type :||Observational|
|Estimated Enrollment :||60000 participants|
|Official Title:||Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus|
|Actual Study Start Date :||September 12, 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2023|
- Diagnostic Test: hemoglobin A1c
The hemoglobin A1c test (A1c) screens for, helps diagnose, and monitors diabetes and prediabetes.
- Stroke or myocardial infarction [ Time Frame: January 2008 to December 2018 ]
- cause specific mortality from infection/sepsis [ Time Frame: January 2008 to December 2018 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216303
|Contact: Crystee Cooper, DHEd||214-947-1280||CrysteeCooper@mhd.com|
|Contact: Jordania L Lilly, MEd||214-947-1280||JordaniaLilly@mhd.com|
|Principal Investigator:||Mangesh Pagadala, MD||The Liver Institute Methodist Dallas Medical Center|