Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus

Withdrawn

• Conditions: Diabetes; Liver Transplant; Complications; Kidney Transplant Failure

• Registration Number: NCT04216303
• Lead Sponsor: Methodist Health System

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.

Study Timeline

• Study Start: 2019-09-12
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Primary Completion: 2021-08-19
• Study Completion: 2021-08-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cause specific mortality from infection/sepsis	January 2008 to December 2018
Stroke or myocardial infarction	January 2008 to December 2018

Trial Locations

Locations (1)

Methodist Health System; 🇺🇸 Dallas, Texas, United States