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

NCT ID: NCT06950788

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2031-01-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary E Rinella, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary E Rinella, MD

Role: CONTACT

mrinella@bsd.uchicago.edu

7737021000

Alan L Hutchison, MD PhD

Role: CONTACT

Alan.Hutchison@uchicagomedicine.org

Facility Contacts

Alan L Hutchison, MD, PhD

Role: primary

Alan.Hutchison@uchicagomedicine.org

773-702-1000

Other Identifiers

IRB23-0691

Identifier Type: -

Identifier Source: org_study_id