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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592524
• Other study ID #: Ramadan fasting and liver
• Status: Completed
• Start date: May 17, 2018
• Est. completion date: June 21, 2018

Study information

• Verified date: July 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 21, 2018
• Est. primary completion date: June 14, 2018
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Behavioral:
• Fasting Ramadan
Muslims recipients refrain from eating and drinking anything from dawn until sunset(14-15 hours)

Locations

Country	Name	City	State
Egypt	Iman Montasser	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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