Secondary Adrenal InsufficiencyNCT05827965
Ramadan Fasting in Secondary Adrenal Insufficiency Patients
A study testing education and drug adjustement in people with Secondary Adrenal Insufficiency and Fasting, Intermittent, run by Hopital La Rabta at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Adrenal Insufficiency, Fasting, Intermittent
- What is being tested?
- education and drug adjustement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cardiac insufficiency,
- respiratory insufficiency,
- hepatic insufficiency,
- renal insufficiency (creatinine clearance < 60 ml/min/1.73m2),
- advanced neoplasia,
- undernutrition,
Show all 21Show fewer
- 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- consent withdrawn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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- education and drug adjustement
- Keywords
- secondary adrenal insufficiency, intermittent fasting, complications, education, glucocorticoid replacement therapy, lifestyle
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and drug adjustementBehavioural
education of the patients (lifestyle) and adjustement of glucocorticoid replacement schedule
| Study group | Role | What they receive |
|---|---|---|
| patients with secondary adrenal insufficiency | Experimental | education and treatment adjustment Receives: Behavioral: education and drug adjustement |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of fasted days
change in the number of fasted days
Measured: one month
prevalence of complications
change in the prevalece of complications
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Mar 2023
- Primary completion30 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Secondary Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before and after education and drug adjustement
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital La Rabta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melika Chihaoui, Hopital La Rabta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827965
- Sponsor's protocol ID
- 1/2023
- Status last verified
- Feb 2025
- First submitted
- 12 Apr 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared on reasonable request.
Publications
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.
PubMed 34213700Chihaoui 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.
PubMed 27878773Chihaoui 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.
PubMed 29129244Hussain 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.
PubMed 32419166Chihaoui 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.
PubMed 31552584Mabrouk M, Chihaoui M, Sta J, Slimane CB, Oueslati I, Yazidi M, Chaker F. Ramadan Fasting Improves Health-Related Quality of Life in Patients With Secondary Adrenal Insufficiency: A Prospective Interventional Case-Control Study. Clin Endocrinol (Oxf). 2025 Oct;103(4):523-530. doi: 10.1111/cen.15286. Epub 2025 Jun 2.
PubMed 40452492Chihaoui M, Mabrouk M, Oueslati I, Khessairi N, Chaker F, Yazidi M. Evaluation of therapeutic education on intermittent fasting in patients with secondary adrenal insufficiency: A clinical trial. Nutrition. 2025 Apr;132:112688. doi: 10.1016/j.nut.2025.112688. Epub 2025 Jan 14.
PubMed 39933257
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ramadan Fasting in Secondary Adrenal Insufficiency Patients
- ClinicalTrials.gov ID
- NCT05827965
- Acronym / sponsor ID
- 1/2023
- Keywords
- secondary adrenal insufficiency, intermittent fasting, complications, education, glucocorticoid replacement therapy, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hopital La RabtaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before and after education and drug adjustement
| Arm | Type | Receives |
|---|---|---|
| patients with secondary adrenal insufficiency | Experimental | Behavioral: education and drug adjustementeducation and treatment adjustment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- cardiac insufficiency,
- respiratory insufficiency,
- hepatic insufficiency,
- renal insufficiency (creatinine clearance < 60 ml/min/1.73m2),
- advanced neoplasia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education and drug adjustementeducation of the patients (lifestyle) and adjustement of glucocorticoid replacement schedule | Behavioural | patients with secondary adrenal insufficiency |
Primary outcome
number of fasted days
Time frame: one month
change in the number of fasted days
prevalence of complications
Time frame: one month
change in the prevalece of complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 34213700Chihaoui 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.
- Background: PubMed 27878773Chihaoui 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.
- Background: PubMed 29129244Chihaoui 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.
- Background: PubMed 32419166Hussain 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.
- Background: PubMed 31552584Chihaoui 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.
- Derived from this study: PubMed 40452492Mabrouk M, Chihaoui M, Sta J, Slimane CB, Oueslati I, Yazidi M, Chaker F. Ramadan Fasting Improves Health-Related Quality of Life in Patients With Secondary Adrenal Insufficiency: A Prospective Interventional Case-Control Study. Clin Endocrinol (Oxf). 2025 Oct;103(4):523-530. doi: 10.1111/cen.15286. Epub 2025 Jun 2.
- Derived from this study: PubMed 39933257Chihaoui M, Mabrouk M, Oueslati I, Khessairi N, Chaker F, Yazidi M. Evaluation of therapeutic education on intermittent fasting in patients with secondary adrenal insufficiency: A clinical trial. Nutrition. 2025 Apr;132:112688. doi: 10.1016/j.nut.2025.112688. Epub 2025 Jan 14.
- Individual participant dataSharing planned: Yes. Data can be shared on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education and drug adjustement in people with Secondary Adrenal Insufficiency and Fasting, Intermittent, run by Hopital La Rabta at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of fasted days (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05827965, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.