Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06950788

Conditions

Cirrhosis, Liver

Diabetes Mellitus Risk

Transplant; Failure, Liver

Transplant-Related Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cirrhosis, Liver

Diabetes Mellitus Risk

Transplant; Failure, Liver

Transplant-Related Disorder

Study ID

NCT06950788

Start date

Mar 12, 2024

Status verified date

May, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Early post-transplant hyperglycemia [ Time Frame: 45 days after transplant ]
  • Post-transplant diabetes [ Time Frame: 45 days to 365 days after liver transplant ]

Central Contacts and Locations

Central contacts

Alan L Hutchison, MD PhD

773-702-1000Alan.Hutchison@uchicagomedicine.org

Mary E Rinella, MD

773-702-1000mrinella@bsd.uchicago.edu

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Alan L Hutchison, MD, PhD

773-702-1000Alan.Hutchison@uchicagomedicine.org

Mary E Rinella, MD

mrinella@bsd.uchicago.edu

Principal Investigator:

Alan L Hutchison, MD PhD

More Information

Sponsor

University of Chicago

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Cirrhosis
  • Post-transplant diabetes
  • New-onset diabetes after transplant
  • Liver transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-05-07.