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

Effect of Ramadan Fasting on Muslim Recipients After Living Donor Liver Transplantation: Single Center Study

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).

Study Overview

• Status: Completed
• Conditions: Liver Transplantation
• Intervention / Treatment: Behavioral: Fasting Ramadan

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Iman Montasser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients underwent Living donor liver transplantation

Description

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

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of fasting on Allograft function among recipients post liver transplantation	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	1 month
Effect of fasting Ramadan on renal functions among recipients post liver transplantation	Comparison between fasting and post fasting renal functions ( serum creatinine, Blood urea nitrogen ,serum sodium and potassium	1 month
Effect of Ramadan fasting on immunosuppressant trough level in liver transplantation recipients	Comparison between fasting and post fasting immunosuppressant drugs trough levels	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2018
• Primary Completion (ACTUAL): June 14, 2018
• Study Completion (ACTUAL): June 21, 2018

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (ACTUAL): July 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Ramadan fasting and liver

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No