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

NCT04216303 | Withdrawn

• 1 other identifier: 037.IMD.2019.D
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Liver Transplant; Complications; Kidney Transplant Failure

Keywords

hemoglobin A1c

Outcome Measures

Primary Outcomes (2)

• Stroke or myocardial infarction

  January 2008 to December 2018

• cause specific mortality from infection/sepsis

  January 2008 to December 2018

Interventions

hemoglobin A1c DIAGNOSTIC_TEST

The hemoglobin A1c test (A1c) screens for, helps diagnose, and monitors diabetes and prediabetes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \<18 years old

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Health System

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mangesh Pagadala, MD

  The Liver Institute Methodist Dallas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: January 2, 2020
• Study Start: September 12, 2019
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

US (1)