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Effect of Novel Donor Lifestyle Optimisation Protocol on Liver Regeneration in Live Liver Donors

NCT04565535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-05-30

No results posted yet for this study

Summary

Steatosis in case of live liver donors is on the rise and around 20- 40 % of prospective liver donors are estimated to have hepatic steatosis. Significant steatosis has been shown to be associated with inferior donor outcomes after liver transplant. Dietary and lifestyle modification has been shown to reduce steatosis and may help improve the donor outcomes after liver transplant. Donors will be randomized between two groups; one will be put under donor lifestyle optimization protocol and the other shall follow normal diet and lifestyle. Donors under optimization protocol would undergo diet modification in the form of healthy, low fat, high protein diet along with exercise for 2 weeks prior to the expected date of surgery. Investigations including liver volumetric assessment, LFT's , lipid profile , Fibroscan shall be done prior to initiation of the diet and then following completion of the 2 weeks of lifestyle modification before surgery. The intraoperative parameters including intraoperative blood loss shall be assessed and a liver biopsy will be taken intraoperatively to assess for steatosis and liver regeneration markers including CK7 and Ki 67 will be assessed. Following surgery, the liver regeneration in donor shall be assessed by doing a liver volumetry by Computed Tomography (CT) at POD7. Post surgery, the donor shall undergo daily LFT's, PT-INR and the time to its normalization and serum bilirubin shall be assessed. Markers of liver regeneration shall also be assessed initially a day before surgery and then at POD 1, 3 and 7.

Conditions

  • Liver Regeneration

Interventions

BEHAVIORAL

Novel donor lifestyle optimisation protocol

Diet based on calorie requirement as calculated by indirect calorimetry. Daily exercise.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Viniyendra Pamecha, FEBS · Institute of Liver & Biliary Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04565535 on ClinicalTrials.gov