Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05827965
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-04-12
Brief Title:
Ramadan Fasting in Secondary Adrenal Insufficiency Patients
Sponsor:
Hopital La Rabta
Organization:
Hopital La Rabta
Study Overview
Official Title:
Ramadan Fasting in Secondary Adrenal Insufficiency Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 767 of adrenal insufficiency patients were exempted from fasting and 505 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 885 signs suggestive of dehydration 492 intense thirst 328 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None