Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry
Liver transplantation (LT) remains the ultimate option to cure intractable end stage liver disease. Nutritional deficiencies are very common among CLD patients and due to this these patients suffer from low bone mineral density leading to osteoporosis and osteopenia. It has been observed that there is substantial reduction in bone density , especially within the first year of LT. The incidence of fractures among LT recipients has been reported to be around 3.5% with vertebral spine being the most common site. Multiple risk factors for osteoporosis after LT has been identified. Some of these include female sex, DM, sedentary lifestyle, pretransplant hypogonadism, Vit-D deficiency and pre-existing bone mineral abnormalities. Patients with CLD are also reported as having osteoblastic dysfunction by many factors, like unconjugated hyperbilirubinemia, decreased synthesis of collagen matrix, and decreased availability of insulin like growth factors. Post-transplant factors among LT recipients include: choice of immunosuppressive therapy like Glucocorticoid and CNIs therapy.
This Observational study aims to analyze the changes in bone mineral metabolism After Liver Transplantation by Bone Mineral Densitometry preoperatively and postoperatively. All eligible adult patients with Chronic Liver Disease undergoing Liver Transplant during the study period will be included in the study. These patients bone mineral density will be assessed using DEXA scan both preop and on Post op at 3 and 6 months. The association between the changes in BMM and various variables such as the sex of the patients, age of patients, etiology of CLD, presence of hepatocellular carcinoma (HCC), ICU stay, Hospital stay will be studied.
Pre-operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 6 months after the Liver Transplant and the bone mineral density will be compared between these patients along with other parameters.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rahul Shivhare, MS
- Phone Number: 01146300000
- Email: rahulshivhare93@gmail.com
Study Contact Backup
- Name: Viniyendra Pamecha, FRCS
- Phone Number: 01146300000
- Email: viniyendra@gmail.com
Study Locations
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-
National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110070
- Recruiting
- Institute of liver and Biliary Sciences
-
Contact:
- Rahul shivhare, MS
- Phone Number: 01143600000
- Email: rahulshivhare93@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All adult patients >18 yrs with Cirrhosis of Liver undergoing Live Donor Liver Transplant
Exclusion Criteria:
- Patients not giving consent.
- LT for ALF
- Pediatric LT recipients
- DDLT recipients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CLD
All chronic liver disease undergoing living donor liver transplant.
|
No intervention as this is an observational study
|
|
ACLF
All acute on chronic liver failure patients undergoing living donor liver transplant.
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No intervention as this is an observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
assessment of changes in bone mineral mass (BMM) after living donor liver transplant
Time Frame: preoperative and at 3 months and 6 months post LDLT
|
preoperative and at 3 months and 6 months post LDLT
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
evaluate the association between the changes in BMM and gender
Time Frame: preoperative and at 3 months and 6 months post LDLT
|
preoperative and at 3 months and 6 months post LDLT
|
|
evaluate the association between the changes in BMM and age of patients
Time Frame: preoperative and at 3 months and 6 months post LDLT
|
preoperative and at 3 months and 6 months post LDLT
|
|
evaluate the association between the changes in BMM and presence of hepatocellular carcinoma (HCC)
Time Frame: preoperative and at 3 months and 6 months post LDLT
|
preoperative and at 3 months and 6 months post LDLT
|
|
evaluate the association between the changes in BMM and etiology
Time Frame: preoperative and at 3 months and 6 months post LDLT
|
preoperative and at 3 months and 6 months post LDLT
|
|
evaluate the association between the changes in BMM with ICU stay and Hospital stay
Time Frame: preoperative and at 3 months and 6 months post LDLT
|
preoperative and at 3 months and 6 months post LDLT
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ILBS-LT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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