Clinical trial NCT04216303: Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus
Official title: Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
Liver Transplant; Complications
Kidney Transplant Failure
Keywords: hemoglobin A1c
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be obtained from UNOS, which is a large, non-profit organization, database about organ transplant recipients in the United States. Data will be collected from January 2008 to December 2018, and compared outcomes (as mentioned above) between liver and combined liver and kidney transplant recipients with A1c values \<6.0, 6.1 to 7.0, 7.1 to 8.0, 8.1 to 8.9, or \>9.0.

Brief summary: 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.

Detailed description: Major cardiovascular events are greatest in liver transplant recipients with sustained post-transplantation diabetes. 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 studies. 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 opinion.

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.

Eligibility criteria: Inclusion Criteria:

* All patients 18 years old or older in the United States with diabetes undergoing or post liver and combined liver and kidney transplant from January 2008 to December 2018.

Exclusion Criteria:

* \<18 years old

Primary outcomes:
measure: Stroke or myocardial infarction
timeFrame: January 2008 to December 2018
measure: cause specific mortality from infection/sepsis
timeFrame: January 2008 to December 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Health System
state: Texas
Study officials:
affiliation: The Liver Institute Methodist Dallas Medical Center
name: Mangesh Pagadala, MD
role: PRINCIPAL_INVESTIGATOR
References: