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NCT Number: NCT06950788

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Alan L Hutchison, MD PhD

PRINCIPAL_INVESTIGATOR

Alan L Hutchison, MD, PhD

CONTACT

[email protected]

773-702-1000

Celeste C Thomas, MD

SUB_INVESTIGATOR

Mary E Rinella, MD

CONTACT

[email protected]

Mary E Rinella, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Early post-transplant hyperglycemia

    Time frame: 45 days after transplant

    Blood sugars above 200 mg/dL or requiring insulin therapy

  2. Post-transplant diabetes

    Time frame: 45 days to 365 days after liver transplant

    Hemoglobin A1c > 6.5% or two-hour glucose from an oral glucose tolerance test ≥ 200 mg/dL after liver transplant

Secondary outcomes

  1. Undiagnosed diabetes in cirrhosis

    Time frame: Before transplant

    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%

Study contacts

Contact information is provided by the study sponsor or research team.

Alan L Hutchison, MD PhD

CONTACT

[email protected]

773-702-1000

Mary E Rinella, MD

CONTACT

[email protected]

773-702-1000

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2031
First posted
Apr 30, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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