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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Alan L Hutchison, MD PhD; Phone Number: 773-702-1000; Email: Alan.Hutchison@uchicagomedicine.org
• Study Contact Backup: Name: Mary E Rinella, MD; Phone Number: 773-702-1000; Email: mrinella@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
      • Contact: Alan L Hutchison, MD, PhD; Phone Number: 773-702-1000; Email: Alan.Hutchison@uchicagomedicine.org
      • Sub-Investigator: Celeste C Thomas, MD
      • Contact: Mary E Rinella, MD; Email: mrinella@bsd.uchicago.edu
      • Sub-Investigator: Mary E Rinella, MD
      • Principal Investigator: Alan L Hutchison, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with cirrhosis undergoing evaluation for liver transplant

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Undiagnosed diabetes in cirrhosis	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%	Before transplant

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Alan L Hutchison, MD PhD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Liver transplantation; Cirrhosis; Post-transplant diabetes; New-onset diabetes after transplant
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Pathological Conditions, Signs and Symptoms; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: IRB23-0691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No