Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients not giving consent.

LT for ALF

Pediatric LT recipients

DDLT recipients

Trial population

all CLD and ACLF patients irrespective of etiology undergoing living donor liver transplant

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • no intervention

    Other intervention

    No intervention as this is an observational study

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: CLD1 intervention
Group B: ACLF1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

evaluate the association between the changes in BMM and gender

Time frame
preoperative and at 3 months and 6 months post LDLT
2

evaluate the association between the changes in BMM and age of patients

Time frame
preoperative and at 3 months and 6 months post LDLT
3

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
4

evaluate the association between the changes in BMM and etiology

Time frame
preoperative and at 3 months and 6 months post LDLT

Other outcomes

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