Ramadan Fasting in Secondary Adrenal Insufficiency Patients

February 26, 2024 updated by: Melika Chihaoui, Hopital La Rabta
Intermittent Ramadan fasting was associated with a risk of complications in patients with adrenal insufficiency. A risk stratification with recommendations (lifestyle and drug adjustment) for fasting in these patients has been recently published. So, this prospective interventional study was carried out to evaluated these recommendations. Patients with secondary adrenal insufficiency and willing to fast Ramadan were included. Before Ramadan, patients underwent a clinical examination and were educated for lifestyle measures and the schedule of glucocorticoid replacement therapy was adjusted. The occurrence of complications and the number of fasted days during the month of Ramadan 2023 were reported and compared with those of Ramadan 2022.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Intermittent fasting during the month of Ramadan is one of the five pillars of Islam and a sacred ritual for Muslims. Patients with chronic diseases seek advice from their physician and insist on fasting. A former study showed that 76.7% of adrenal insufficiency patients were exempted from fasting and 50.5% of them fasted against the advice of their physician. Few studies have assessed the risk of complications in adrenal insufficiency patients. The most frequently reported complications were asthenia (88.5%), signs suggestive of dehydration (49.2%), intense thirst (32.8%), and signs of hypoglycaemia (18%). Hypoglycaemia was detected by 24 hour-continuous glucose monitoring in 10% of fasting patients with secondary adrenal insufficiency (SAI). These complications were more frequent in patients with insufficient knowledge of the disease. A literature review was published 2021 and a risk stratification of patients with adrenal insufficiency and recommendations for patient education and therapeutic adjustment were proposed. However, no study has evaluated the effect of these measures on Ramadan fasting in SAI.

The objectives were to:

  1. compare the number of fasted days and the prevalence of complications during Ramadan fasting before (2022) and after therapeutic education and treatment adjustment (2023) in patients with SAI.
  2. determine the factors associated with complications during Ramadan fasting in SAI.

Methods:

Before the month of Ramadan 2023, patients meeting the inclusion criteria were enrolled. All patients signed a written informed consent.

During the first visit, the following data were recorded:

  • gender, age, medical and surgical history, current treatments, medication schedule, the 2022 fast (number of fasted days, complications (type, days, time, break of the fast for a complication)).
  • weight, height, lying and standing blood pressure.
  • Some data were taken from the medical file: other affected pituitary axes, etiology of the SAI, results of the insulin hypoglycaemia test if performed (baseline cortisol, peak level, peak time, area under the curve), plasma creatinine.

Subsequently, patient education (the particularities of the disease, the risks and lifestyle measures) and therapeutic adjustments were performed according to the recommendations published by Chihaoui et al in Endocrine, 2021.

Throughout the month of Ramadan 2023, patients filled in forms indicating for the fasted days: dinner time, shour time, sleep time, unusual physical activity, treatment schedule, occurrence of complications: type, time, break of the fast for a complication.

Throughout the study, regular telephone contact with one of the investigators was performed for any additional information, advice or therapeutic adjustment.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • University Hospital La Rabta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged over 18 years
  • Secondary adrenal insufficiency patients
  • Substituted with glucocorticoids for more than one year.
  • Willing to fast during the month of Ramadan 2023

Exclusion Criteria:

  • cardiac insufficiency,
  • respiratory insufficiency,
  • hepatic insufficiency,
  • renal insufficiency (creatinine clearance < 60 ml/min/1.73m2),
  • advanced neoplasia,
  • undernutrition,
  • diabetes insipidus,
  • diabetes mellitus,
  • neuro-psychiatric disease,
  • infectious disease
  • chronic inflammatory disease,
  • hyperthyroidism,
  • uncontrolled hypothyroidism,
  • alcoholism,
  • diuretic intake,
  • glucocorticoid treatment for purposes other than substitution,
  • treatment with enzyme inducers,
  • pregnancy,
  • breastfeeding
  • consent withdrawn
  • study discontinuation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with secondary adrenal insufficiency
education and treatment adjustment
Behavioral: education and drug adjustement
education of the patients (lifestyle) and adjustement of glucocorticoid replacement schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of fasted days
Time Frame: one month
change in the number of fasted days
one month
prevalence of complications
Time Frame: one month
change in the prevalece of complications
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital La Rabta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data can be shared on reasonable request.

IPD Sharing Time Frame

after the publication of this study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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