DiabetesNCT04216303
Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus
An observational study of Diabetes and Liver Transplant; Complications, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Liver Transplant; Complications, Kidney Transplant Failure
- What is being tested?
- hemoglobin A1c
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2019to 19 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- hemoglobin A1c
- Keywords
- hemoglobin A1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemoglobin A1cDiagnostic test
The hemoglobin A1c test (A1c) screens for, helps diagnose, and monitors diabetes and prediabetes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke or myocardial infarction
Measured: January 2008 to December 2018
cause specific mortality from infection/sepsis
Measured: January 2008 to December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start12 Sep 2019
- Primary completion19 Aug 2021 (estimated)
- Study completion19 Aug 2021
Why it stopped: PI decided to stop the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mangesh Pagadala, MD, Principal investigator, The Liver Institute Methodist Dallas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216303
- Sponsor's protocol ID
- 037.IMD.2019.D
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2019
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04216303
- Acronym / sponsor ID
- 037.IMD.2019.D
- Keywords
- hemoglobin A1c
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI decided to stop the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 19 Aug 2021 (estimated)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemoglobin A1cThe hemoglobin A1c test (A1c) screens for, helps diagnose, and monitors diabetes and prediabetes. | Diagnostic test | – |
Primary outcome
Stroke or myocardial infarction
Time frame: January 2008 to December 2018
cause specific mortality from infection/sepsis
Time frame: January 2008 to December 2018
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mangesh Pagadala, MD principal investigator
The Liver Institute Methodist Dallas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Liver Transplant; Complications, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke or myocardial infarction (time frame: January 2008 to December 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.