Optimal A1c Control in Post Liver or Combined Liver and K... | NCT04216303

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

NCT04216303

Sponsor

Methodist Health System

Status

Withdrawn

Last Update Posted

Sep 17, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Diabetes
Liver Transplant; Complications
Kidney Transplant Failure

Interventions

hemoglobin A1c

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI decided to stop the study

Expanded Access Info

Start Date

Sep 12, 2019Actual

Primary Completion Date

Aug 19, 2021Estimated

Completion Date

Aug 19, 2021Actual

First Submitted Date

Sep 12, 2019

First Submission Date that Met QC Criteria

Dec 30, 2019

First Posted Date

Jan 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2021

Last Update Posted Date

Sep 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hemoglobin A1c	Diagnostic Test	The hemoglobin A1c test (A1c) screens for, helps diagnose, and monitors diabetes and prediabetes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroke or myocardial infarction		January 2008 to December 2018
cause specific mortality from infection/sepsis		January 2008 to December 2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mangesh Pagadala, MD	The Liver Institute Methodist Dallas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Health System		Dallas	Texas	75203	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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