Clinical trial NCT06950788: Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant
Official title: Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis, Liver
Diabetes Mellitus Risk
Transplant; Failure, Liver
Transplant-Related Disorder
Keywords: Cirrhosis
Post-transplant diabetes
New-onset diabetes after transplant
Liver transplantation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with cirrhosis undergoing evaluation for liver transplant

Brief summary: 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.

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

Primary outcomes:
measure: Early post-transplant hyperglycemia
timeFrame: 45 days after transplant
measure: Post-transplant diabetes
timeFrame: 45 days to 365 days after liver transplant
Secondary outcomes:
measure: Undiagnosed diabetes in cirrhosis
timeFrame: Before transplant
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mary E Rinella, MD
role: PRINCIPAL_INVESTIGATOR
References: