Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant

Recruiting

• Conditions: Cirrhosis, Liver; Diabetes Mellitus Risk; Transplant; Failure, Liver; Transplant-Related Disorder

• Registration Number: NCT06950788
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study Start: 2024-03-12
• Status Verified: 2025-04
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-06
• Study Completion: 2031-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early post-transplant hyperglycemia	45 days after transplant	Blood sugars above 200 mg/dL or requiring insulin therapy
Post-transplant diabetes	45 days to 365 days after liver transplant	Hemoglobin A1c \> 6.5% or two-hour glucose from an oral glucose tolerance test ≥ 200 mg/dL after liver transplant

Secondary Outcome Measures

Name	Time	Method
Undiagnosed diabetes in cirrhosis	Before transplant	Two-hour glucose in an oral glucose tolerance test ≥ 200 mg/dL in an individual with cirrhosis with a hemoglobin A1c less than 6.5%

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States