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Completed

NCT Number: NCT03592524

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Iman Montasser

Cairo, 11566, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fasting Ramadan

Behavioral

Muslims recipients refrain from eating and drinking anything from dawn until sunset(14-15 hours)

Primary outcomes

  1. Effect of fasting on Allograft function among recipients post liver transplantation

    Time frame: 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

  2. Effect of fasting Ramadan on renal functions among recipients post liver transplantation

    Time frame: 1 month

    Comparison between fasting and post fasting renal functions ( serum creatinine, Blood urea nitrogen ,serum sodium and potassium

  3. Effect of Ramadan fasting on immunosuppressant trough level in liver transplantation recipients

    Time frame: 1 month

    Comparison between fasting and post fasting immunosuppressant drugs trough levels

Secondary outcomes

  1. Effect of Ramadan fasting on blood pressure Among hypertensive recipients on antihypertensive drugs

    Time frame: 1 month

    For hypertension patients regular monitoring of blood pressure by sphingomanometer for any changes in these parameters on daily bases during the months

  2. Effect of fasting Ramadan on blood sugar control among diabetics recipients

    Time frame: 1 month

    Comparison between fasting and post fasting on blood sugar by daily measures of fasting and 2 hours postprandial blood sugar

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2018
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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