Effect of Ramadan Fasting on Muslim Recipients After Living Donor Liver Transplantation

Completed

• Conditions: Liver Transplantation

• Registration Number: NCT03592524
• Lead Sponsor: Ain Shams University

Brief Summary

The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after liver transplantation (LT).

Detailed Description

Very limited data in the literature about how to apply Ramadan fasting in the post liver transplant setting. The timing of Ramadan is changeable according to the lunar year and according to time of down and sunset in each country. In Egypt, for example, Ramadan fasting this year started 17th of May and finished 14th June with average fasting hours of 15-16 hours The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after LT.This prospective study included 45 recipients who underwent LT at Ain Shams Center for Organ Transplant (ASCOT), Cairo, Egypt.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-17
• Primary Completion: 2018-06-14
• Study Completion: 2018-06-21
• Study First Submitted: 2018-06-22
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-18
• Last Update Submitted: 2018-07-18
• Study First Posted: 2018-07-19
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• • Recipients completed their first year after LDLT

  • Normal liver and renal functions at least in the last 3 months before fasting
  • No reported rejection episodes in the last 6 months before the study
  • Recipients wishing to fast Ramadan
  • Informed consent about the study

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Exclusion Criteria

• • First year of LDLT

  • Recipients transplanted for Budd Chiari syndrome
  • Recipients with vascular stents (hepatic artery , portal vein or hepatic vein stents) requiring long life anticoagulation
  • Creatinine clearance <60 ml/min or serum creatinine >1.5 mg/dl at time of initial enrolment in the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of fasting on Allograft function among recipients post liver transplantation	1 month	Comparison between pre and post fasting state as regards allograft lfunctions , reflected by measuring AST, ALT(liver enzymes) , serum bilirubin , serum albumin +\\_ liver biopsy if rejection is suspected
Effect of fasting Ramadan on renal functions among recipients post liver transplantation	1 month	Comparison between fasting and post fasting renal functions ( serum creatinine, Blood urea nitrogen ,serum sodium and potassium
Effect of Ramadan fasting on immunosuppressant trough level in liver transplantation recipients	1 month	Comparison between fasting and post fasting immunosuppressant drugs trough levels

Secondary Outcome Measures

Name	Time	Method
Effect of fasting Ramadan on blood sugar control among diabetics recipients	1 month	Comparison between fasting and post fasting on blood sugar by daily measures of fasting and 2 hours postprandial blood sugar
Effect of Ramadan fasting on blood pressure Among hypertensive recipients on antihypertensive drugs	1 month	For hypertension patients regular monitoring of blood pressure by sphingomanometer for any changes in these parameters on daily bases during the months

Trial Locations

Locations (1)

Iman Montasser; 🇪🇬 Cairo, Egypt