Actively Recruiting
Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant
Led by University of Chicago · Updated on 2026-05-07
60
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to identify risk factors for developing diabetes after liver transplant in adults with cirrhosis who do not have diabetes at the time of evaluation. The study explores whether tests such as laboratory work, body measurements, functional tests, imaging, wrist activity monitoring, continuous glucose monitoring, and oral glucose tolerance testing can predict post-transplant diabetes. The University of Chicago is leading this observational study to improve understanding of diabetes risk in this population. Participants will receive devices including a continuous glucose monitor, wrist actigraph, and home sleep apnea testing device, along with questionnaires about demographics, sleep, and physical activity. They will undergo a two-hour oral glucose tolerance test with frequent sampling and body composition analysis using bio-electrical impedance. These tests, except the sleep apnea test, will be repeated every three months before and through the transplant. After transplant, testing resumes at three months or one month after steroid doses are minimized. One year post-transplant, glucose monitoring and oral glucose tolerance testing stop, but medical follow-up continues electronically for up to five years. During the study, participants will be monitored regularly with various tests and questionnaires to assess glucose tolerance and insulin secretion. Researchers will track early post-transplant high blood sugar and diabetes development up to one year after transplant. Long-term health outcomes will be followed electronically up to five years after the transplant. The study involves multiple visits, device usage, and tests to gather detailed information about changes in glucose tolerance throughout the transplant process.
CONDITIONS
Brief Title
Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients presenting to liver transplant clinic with a diagnosis of cirrhosis.
- Age >18 years.
- Ability to understand and sign written consent form, or have a legally-authorized representative or proxy who can be approached for consent
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Variable period until liver transplant
Participants use a continuous glucose monitor, wrist actigraph, and complete questionnaires. They undergo outpatient oral glucose tolerance tests and body composition measurements every three months until liver transplantation.
Outpatient visits every 3 months for testing and monitoring
Duration - From liver transplant to 1 year post-transplant
Participants continue the same testing protocol after liver transplantation, restarting tests at 3 months or 1 month after post-transplant steroids are reduced to their lowest level.
Outpatient visits every 3 months for testing and monitoring
Duration - Up to 5 years post-transplant
Participants are no longer monitored with continuous glucose or oral glucose tolerance tests but their care is followed electronically to assess outcomes up to five years post-transplant.
Trial Site Locations
Total: 1 location
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
A
Alan L Hutchison, MD PhD
M
Mary E Rinella, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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