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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216303
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diabetes Liver Transplant; Complications Kidney Transplant Failure Diagnostic Test: hemoglobin A1c

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 60000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: hemoglobin A1c
    The hemoglobin A1c test (A1c) screens for, helps diagnose, and monitors diabetes and prediabetes.


Primary Outcome Measures :
  1. Stroke or myocardial infarction [ Time Frame: January 2008 to December 2018 ]
  2. cause specific mortality from infection/sepsis [ Time Frame: January 2008 to December 2018 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. We will collect data from January 2008 to December 2018, and compare 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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Crystee Cooper, DHEd 214-947-1280 CrysteeCooper@mhd.com
Contact: Jordania L Lilly, MEd 214-947-1280 JordaniaLilly@mhd.com

Locations
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United States, Texas
Methodist Health System Recruiting
Dallas, Texas, United States, 75203
Contact: Crystee Cooper, DHed    214-947-1280    CrysteeCooper@mhd.com   
Contact: Jordania L Lilly, MEd    214-947-1280    JordaniaLilly@mhd.com   
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Mangesh Pagadala, MD The Liver Institute Methodist Dallas Medical Center
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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT04216303    
Other Study ID Numbers: 037.IMD.2019.D
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Methodist Health System:
hemoglobin A1c
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases