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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | Before transplant |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with cirrhosis undergoing evaluation for liver transplant
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alan L Hutchison, MD PhD | Contact | 773-702-1000 | Alan.Hutchison@uchicagomedicine.org | |
| Mary E Rinella, MD | Contact | 773-702-1000 | mrinella@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alan L Hutchison, MD PhD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.