An interventional study of education and drug adjustement in Secondary Adrenal Insufficiency and Fasting, Intermittent, sponsored by Hopital La Rabta. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Hopital La Rabta · Not applicable, Interventional, and Prevention
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.
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:
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:
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.
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Exclusion Criteria:
education and treatment adjustment
Behavioral: education and drug adjustement
education of the patients (lifestyle) and adjustement of glucocorticoid replacement schedule
number of fasted days
change in the number of fasted days
Time frame: one month
prevalence of complications
change in the prevalece of complications
Time frame: one month
Plan to share: Yes — Data can be shared on reasonable request.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Hopital La Rabta