Cirrhosis, Liver, Diabetes Mellitus Risk, Transplant; Failure, Liver, Transplant-Related Disorder
Conditions
Keywords
Cirrhosis, Post-transplant diabetes, New-onset diabetes after transplant, Liver transplantation
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.
Interventions
None listed
Sponsors
University of Chicago
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early post-transplant hyperglycemia | 45 days after transplant | Blood sugars above 200 mg/dL or requiring insulin therapy |
| Post-transplant diabetes | 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
| Measure | Time frame | Description |
|---|---|---|
| Undiagnosed diabetes in cirrhosis | 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% |
Countries
United States
Contacts
CONTACTAlan L Hutchison, MD PhD
CONTACTMary E Rinella, MD
PRINCIPAL_INVESTIGATORAlan L Hutchison, MD PhD
University of Chicago
Outcome results
None listed