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

NCT06950788 | Recruiting

• 1 other identifier: IRB23-0691
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Undiagnosed diabetes in cirrhosis

  Before transplant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with cirrhosis undergoing evaluation for liver transplant

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Specimens collected will include blood, urine, and stool. If the subject goes to liver transplant, during the surgery tissue will be collected from the implanting liver, explant liver, abdominal muscle, visceral fat, and subcutaneous fat. If the subject obtains a standard of care liver biopsy, an extra pass may be taken for liver tissue.

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary E Rinella, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary E Rinella, MD

CONTACT

7737021000; mrinella@bsd.uchicago.edu

Alan L Hutchison, MD PhD

CONTACT

Alan.Hutchison@uchicagomedicine.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: March 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)