Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Liver, Diabetes Mellitus Risk, Transplant; Failure, Liver, Transplant-Related Disorder. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to establish risk factors for post-transplant in adult individuals with cirrhosis without diabetes undergoing liver transplant evaluation. The question being addressed is: can laboratory work, anthropometric tests, functional tests, imaging, and advanced measurements such as wrist actigraphy, continuous glucose monitoring, or oral glucose tolerance testing predict the development of diabetes after liver transplant? Participants will be asked to periodically participate in wearing a continuous glucose monitor and wrist actigraph and obtain an oral glucose tolerance test both before and after liver transplant.
Detailed description
Participants will be enrolled from the liver transplant clinic and will be given a continuous glucose monitor, a wrist actigraph, a home sleep apnea testing device, and a questionnaire packet to collect demographics, sleep quality, and physical activity information. They will be scheduled for an outpatient two-hour oral glucose tolerance test, which will use a frequently sampling protocol to allow for mathematical modeling of insulin secretion. They will undergo body composition measurements using a bio-electrical impedance analysis device. Subjects will undergo these tests, excluding the home sleep apnea test, every three months until and through liver transplantation, after which they will restart the protocol at three months, or one month after post-transplant steroids are weaned to their lowest level. After they are one year post-transplant, they will no longer participate in continuous glucose monitoring or oral glucose tolerance testing, but their care will be followed electronically to assess outcomes up to five years post-transplant.
Primary outcome measures
- Early post-transplant hyperglycemia [Time frame: 45 days after transplant]
- Post-transplant diabetes [Time frame: 45 days to 365 days after liver transplant]
Secondary outcome measures (1)
- Undiagnosed diabetes in cirrhosis [Time frame: Before transplant]
Eligibility criteria
Inclusion criteria
- Patients presenting to liver transplant clinic with a diagnosis of cirrhosis.
- Age >18 yrs.
- Ability to understand and sign written consent form, or have a legally-authorized representative or proxy who can be approached for consent
Exclusion criteria
- Patients without consent
- Patients with implantable cardioverter defibrillator devices or automated implantable cardioverter defibrillator devices will be excluded from the bio-electrical impedance analysis portion of the measurements.
- Patients with unremovable electrical medical devices or devices that cannot turn off will be excluded from the bio-electrical impedance analysis measurements
- Pregnant patients
- Incarcerated patients
- Patients with a history of type 2 diabetes mellitus diagnosed > 5 years ago will be excluded from the Oral Glucose Tolerance Test portion of the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Chicago Medical Center — Chicago
Identifiers
NCT: NCT06950788 · IRB23-0691