Ramadan Fasting in Secondary Adrenal Insufficiency Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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.

Official Title
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Ramadan Fasting in Secondary Adrenal Insufficiency Patients

Conditions
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Secondary Adrenal Insufficiency, Fasting, Intermittent

Intervention / Treatment
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* Behavioral: education and drug adjustement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: before and after education and drug adjustement
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secondary adrenal insufficiency, intermittent fasting, complications, education, glucocorticoid replacement therapy, lifestyle