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Ramadan Fasting in Secondary Adrenal Insufficiency Patients

Primary Purpose

Secondary Adrenal Insufficiency, Fasting, Intermittent

Status
Active
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
education and drug adjustement
Sponsored by
Hopital La Rabta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Secondary Adrenal Insufficiency focused on measuring secondary adrenal insufficiency, intermittent fasting, complications, education, glucocorticoid replacement therapy, lifestyle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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treatment for purposes other than substitution, treatment with enzyme inducers, pregnancy, breastfeeding consent withdrawn study discontinuation.

Sites / Locations

  • University Hospital La Rabta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with secondary adrenal insufficiency

Arm Description

education and treatment adjustment

Outcomes

Primary Outcome Measures

number of fasted days
change in the number of fasted days
prevalence of complications
change in the prevalece of complications

Secondary Outcome Measures

Full Information

First Posted
April 12, 2023
Last Updated
October 12, 2023
Sponsor
Hopital La Rabta
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1. Study Identification

Unique Protocol Identification Number
NCT05827965
Brief Title
Ramadan Fasting in Secondary Adrenal Insufficiency Patients
Official Title
Ramadan Fasting in Secondary Adrenal Insufficiency Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital La Rabta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Adrenal Insufficiency, Fasting, Intermittent
Keywords
secondary adrenal insufficiency, intermittent fasting, complications, education, glucocorticoid replacement therapy, lifestyle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
before and after education and drug adjustement
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with secondary adrenal insufficiency
Arm Type
Experimental
Arm Description
education and treatment adjustment
Intervention Type
Behavioral
Intervention Name(s)
education and drug adjustement
Intervention Description
education of the patients (lifestyle) and adjustement of glucocorticoid replacement schedule
Primary Outcome Measure Information:
Title
number of fasted days
Description
change in the number of fasted days
Time Frame
one month
Title
prevalence of complications
Description
change in the prevalece of complications
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospital La Rabta
City
Tunis
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be shared on reasonable request.
IPD Sharing Time Frame
after the publication of this study
Citations:
PubMed Identifier
34213700
Citation
Chihaoui M, Yazidi M, Oueslati I, Khessairi N, Chaker F. Intermittent fasting in adrenal insufficiency patients: a review and guidelines for practice. Endocrine. 2021 Oct;74(1):11-19. doi: 10.1007/s12020-021-02804-z. Epub 2021 Jul 2.
Results Reference
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PubMed Identifier
27878773
Citation
Chihaoui M, Chaker F, Yazidi M, Grira W, Ben Amor Z, Rejeb O, Slimane H. Ramadan fasting in patients with adrenal insufficiency. Endocrine. 2017 Jan;55(1):289-295. doi: 10.1007/s12020-016-1186-0. Epub 2016 Nov 23.
Results Reference
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PubMed Identifier
29129244
Citation
Chihaoui M, Grira W, Bettaieb J, Yazidi M, Chaker F, Rejeb O, Oueslati I, Feki M, Kaabachi N, Slimane H. The risk for hypoglycemia during Ramadan fasting in patients with adrenal insufficiency. Nutrition. 2018 Jan;45:99-103. doi: 10.1016/j.nut.2017.07.014. Epub 2017 Aug 3.
Results Reference
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PubMed Identifier
32419166
Citation
Hussain S, Hussain S, Mohammed R, Meeran K, Ghouri N. Fasting with adrenal insufficiency: Practical guidance for healthcare professionals managing patients on steroids during Ramadan. Clin Endocrinol (Oxf). 2020 Aug;93(2):87-96. doi: 10.1111/cen.14250. Epub 2020 Jun 15.
Results Reference
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PubMed Identifier
31552584
Citation
Chihaoui M, Mimita W, Oueslati I, Rejeb O, Ben Amor Z, Grira W, Yazidi M, Chaker F. Prednisolone or hydrocortisone replacement in patients with corticotrope deficiency fasting during Ramadan result in similar risks of complications and quality of life: a randomized double-blind controlled trial. Endocrine. 2020 Jan;67(1):155-160. doi: 10.1007/s12020-019-02082-w. Epub 2019 Sep 24.
Results Reference
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Ramadan Fasting in Secondary Adrenal Insufficiency Patients

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