Cirrhosis, LiverNCT06950788
Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant
An observational study of Cirrhosis, Liver and Diabetes Mellitus Risk, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Liver, Diabetes Mellitus Risk, Transplant; Failure, Liver
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with cirrhosis undergoing evaluation for liver transplant
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Alan L Hutchison, MD, PhD, 773-702-1000, Alan.Hutchison@uchicagomedicine.org
Mary E Rinella, MD, mrinella@bsd.uchicago.edu
About this study
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.
Read the 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
- Keywords
- Cirrhosis, Post-transplant diabetes, New-onset diabetes after transplant, Liver transplantation
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Early post-transplant hyperglycemia
Blood sugars above 200 mg/dL or requiring insulin therapy
Measured: 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
Measured: 45 days to 365 days after liver transplant
Secondary outcomes (1)
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%
Measured: Before transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start12 Mar 2024
- Primary completionJun 2027 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan L Hutchison, MD PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950788
- Sponsor's protocol ID
- IRB23-0691
- Status last verified
- May 2026
- First submitted
- 22 Apr 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant
- ClinicalTrials.gov ID
- NCT06950788
- Acronym / sponsor ID
- IRB23-0691
- Conditions
- Cirrhosis, Liver, Diabetes Mellitus Risk, Transplant; Failure, Liver, Transplant-Related Disorder
- Keywords
- Cirrhosis, Post-transplant diabetes, New-onset diabetes after transplant, Liver transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with cirrhosis undergoing evaluation for liver transplant
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early post-transplant hyperglycemia
Time frame: 45 days after transplant
Blood sugars above 200 mg/dL or requiring insulin therapy
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
1 secondary outcome
Undiagnosed diabetes in cirrhosis
Time frame: Before transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan L Hutchison, MD PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver and Diabetes Mellitus Risk, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan L Hutchison, MD PhD (773-702-1000, Alan.Hutchison@uchicagomedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early post-transplant hyperglycemia (time frame: 45 days after transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.