Primary Adrenal InsufficiencyNCT06299020
Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency
A study testing intermittent fasting in people with Primary Adrenal Insufficiency and Intermittent Fasting, run by Hopital La Rabta at 1 site in Tunisia.
Trial summary
In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Primary Adrenal Insufficiency, Intermittent Fasting
- What is being tested?
- intermittent fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTunisia
- Study dates
- 4 Mar 2024to 1 Dec 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary adrenal insufficiency
- Disease duration of at least one year
- Substituted with hydrocortisone and fludrocortisone
- Wishing to fast during the month of Ramadan 2024
Who cannot join
- Diabetes mellitus
- Renal insufficiency
- Hepatic insufficiency
- Cardiac insufficiency
- Respiratory insufficiency
- Use of hypoglycaemic agents
Show all 11Show fewer
- Use of diuretics
- Use of glucocorticoids other than those prescribed for replacement
- Poor control of the disease (asthenia, malaise, melanoderma, discontinuation of treatment, etc.)
- Pregnancy
- Breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting).
Read the detailed description
The risk of hypoglycaemia in primary adrenal insufficiency (PAI) is well known but has been only few studied. It is explained by cortisol insufficiency. Only a few publications concerned this subject. The risk of hypoglycaemia seems to be increased during acute decompensation, following cessation of treatment and during fasting or delayed food intake. So, this risk would be increased during intermittent fasting such as the Ramadan fast. A previous study carried out in the endocrinology department of La Rabta University Hospital involving 30 subjects with secondary adrenal insufficiency who were monitored by continuous glucose monitoring (CGM) for 24 hours showed three cases of hypoglycaemia during intermittent fasting and no hypoglycaemia outside fasting. Studies assessing the risks of intermittent fasting concerned subjects with secondary adrenal insufficiency. No study assessed the risks of intermittent fasting in PAI. Furthermore, given the mineralocorticoid deficiency in PAI, there is also a risk of dehydration and hypotension.
Aims of the study:
Overall objective: to assess the risks of intermittent fasting in subjects with primary adrenal insufficiency.
Specific objectives:
- To assess the frequency of hypoglycaemia in subjects with primary adrenal insufficiency during fasting and outside fasting.
- To assess the frequency of dehydration in subjects with primary adrenal insufficiency during fasting and outside fasting.
- To study the factors associated with hypoglycaemia and dehydration.
Methods :
Type of study: prospective, cross over, comparative study with subjects taken as their own controls.
A group of 15 patients will be studied during the week preceding the month of Ramadan (non fasting week) and the first week of Ramadan (fasting week). A group of 15 patients will be studied during the fourth week of Ramadan (fasting week) and the first week after Ramadan (non fasting week). The analysis will thus concern 210 fasted days and 210 non-fasted days.
The included patients will be examined on two occasions 14 days apart. Visit 1 will include a clinical examination, the setting up of the continuous glucose monitoring system, a fasting blood sampling and the delivery of monitoring sheets.
Clinical data:
- Demographic data: age, gender
- Data relating to PAI: age, aetiology, replacement therapy. Fasting history and course (number of days fasted, occurrence of complications).
- Quality of life and quality of sleep questionnaire.
- weight, height, waist circumference, supine and standing blood pressure, heart rate, presence of melanoderma, signs of dehydration.
The patient will be given dietary and hygiene advice on fasting and the treatment (gluco- and mineral-corticosteroids) will be adjusted if necessary, in accordance with the recommendations published in 2021 and 2022.
Biological data: urea, iono
During the study period (two weeks), patients will be asked to fill in a monitoring form which will include details of medication taken, waking and bedtimes, physical activity and the occurrence of any discomfort (asthenia, signs of hypoglycaemia, signs of arterial hypotension or other).
Patients will be monitored during the fasting period by one of the investigators by telephone in order to check compliance with the protocol and the possible occurrence of complications.
Criteria for breaking the fasting: occurrence of malaise during fasting, hypoglycaemia diagnosed by CGM, elevation of urea or hyperkalaemia.
Visit 2 : the patients will undergo a clinical examination including quality of life and quality of sleep questionnaires and a physical examination, fasting blood sampling, recovery of the continuous glucose monitoring system and monitoring sheets.
Diagnosis criteria:
- Hypoglycaemia is defined as interstitial glucose measured during CGM < 2.8mmol/l.
- Dehydration is defined by the presence of arterial hypotension (BP <9/6cmHg or orthostatic hypotension) or elevated plasma urea.
- Being tested
- intermittent fasting
- Keywords
- continuous glucose monitoring, Hypoglycemia, Dehydration
- Medical subject headings
- Addison Disease, Intermittent Fasting, Hypoglycemia, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent fastingBehavioural
Also called Ramadan fasting
fasting from predawn to sunset (no eating and no drinking), for approximately 16 hours.
| Study group | Role | What they receive |
|---|---|---|
| Non fasting | No intervention | Non fasting arm: usual diet and behavior |
| Fasting | Experimental | Intermittent fasting Receives: Behavioral: intermittent fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoglycemia
clinical signs or interstitial glucose lower than 2.8mmol/l
Measured: the fasting period from predawn to sunset (approximately 16 hours)
Secondary outcomes (1)
Dehydration
clinical signs of dehydration or increase of plasmatic urea
Measured: the fasting period from predawn to sunset (approximately 16 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start4 Mar 2024
- Primary completion20 Apr 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06299020
- Sponsor's protocol ID
- HLaRabta24
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2024
- Last updated
- 14 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 upon reasonable request.
Publications
Lee SC, Baranowski ES, Sakremath R, Saraff V, Mohamed Z. Hypoglycaemia in adrenal insufficiency. Front Endocrinol (Lausanne). 2023 Nov 20;14:1198519. doi: 10.3389/fendo.2023.1198519. eCollection 2023.
PubMed 38053731Kawahara T, Tsuji M, Tominaga N, Toyama N, Toda M. Frequency of Adrenal Insufficiency in Patients With Hypoglycemia in an Emergency Department: A Cross-sectional Study. J Endocr Soc. 2022 Aug 4;6(10):bvac119. doi: 10.1210/jendso/bvac119. eCollection 2022 Oct 1.
PubMed 36042975Watanabe T, Ozawa A, Ishii S, Tomaru T, Shibusawa N, Saito T, Yamada E, Horiguchi K, Nakajima Y, Matsumoto S, Yoshino S, Katano-Toki A, Hashimoto K, Mori M, Okada S, Satoh T, Yamada M. Usage of continuous glucose monitoring (CGM) for detecting an unrecognized hypoglycemia and management of glucocorticoid replacement therapy in adult patients with central hypoadrenalism. Endocr J. 2018 May 28;65(5):547-556. doi: 10.1507/endocrj.EJ16-0387. Epub 2018 Apr 4.
PubMed 29618670Chihaoui 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 29129244Chihaoui 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 34213700Hussain 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 32419166Sta J, Chihaoui M, Mabrouk M, Kamoun E, Belhadjsliman C, Khessairi N, Oueslati I, Yazidi M, Chaker F. Ramadan fasting in patients with primary adrenal insufficiency: evaluation of the risk of complications, quality of life and sleep, and associated factors. J Diabetes Metab Disord. 2026 Sep 30;25(2):275. doi: 10.1007/s40200-026-02088-y. eCollection 2026 Dec.
PubMed 42824572Chihaoui M, Sta J, Kamoun E, Belhadjsliman C, Khessairi N, Oueslati I, Yazidi M, Chaker F, Feki M. Hypoglycaemia and other risks of ramadan fasting in patients with primary adrenal insufficiency: A prospective controlled trial using 24-hour glucose monitoring. J Endocrinol Invest. 2026 Feb;49(2):359-367. doi: 10.1007/s40618-025-02728-9. Epub 2025 Oct 18.
PubMed 41108503
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency
- ClinicalTrials.gov ID
- NCT06299020
- Acronym / sponsor ID
- HLaRabta24
- Keywords
- continuous glucose monitoring, Hypoglycemia, Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hopital La RabtaUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 7 Mar 2024 (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.
In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting).
Detailed description
The risk of hypoglycaemia in primary adrenal insufficiency (PAI) is well known but has been only few studied. It is explained by cortisol insufficiency. Only a few publications concerned this subject. The risk of hypoglycaemia seems to be increased during acute decompensation, following cessation of treatment and during fasting or delayed food intake. So, this risk would be increased during intermittent fasting such as the Ramadan fast. A previous study carried out in the endocrinology department of La Rabta University Hospital involving 30 subjects with secondary adrenal insufficiency who were monitored by continuous glucose monitoring (CGM) for 24 hours showed three cases of hypoglycaemia during intermittent fasting and no hypoglycaemia outside fasting. Studies assessing the risks of intermittent fasting concerned subjects with secondary adrenal insufficiency. No study assessed the risks of intermittent fasting in PAI. Furthermore, given the mineralocorticoid deficiency in PAI, there is also a risk of dehydration and hypotension.
Aims of the study:
Overall objective: to assess the risks of intermittent fasting in subjects with primary adrenal insufficiency.
Specific objectives:
- To assess the frequency of hypoglycaemia in subjects with primary adrenal insufficiency during fasting and outside fasting.
- To assess the frequency of dehydration in subjects with primary adrenal insufficiency during fasting and outside fasting.
- To study the factors associated with hypoglycaemia and dehydration.
Methods :
Type of study: prospective, cross over, comparative study with subjects taken as their own controls.
A group of 15 patients will be studied during the week preceding the month of Ramadan (non fasting week) and the first week of Ramadan (fasting week). A group of 15 patients will be studied during the fourth week of Ramadan (fasting week) and the first week after Ramadan (non fasting week). The analysis will thus concern 210 fasted days and 210 non-fasted days.
The included patients will be examined on two occasions 14 days apart. Visit 1 will include a clinical examination, the setting up of the continuous glucose monitoring system, a fasting blood sampling and the delivery of monitoring sheets.
Clinical data:
- Demographic data: age, gender
- Data relating to PAI: age, aetiology, replacement therapy. Fasting history and course (number of days fasted, occurrence of complications).
- Quality of life and quality of sleep questionnaire.
- weight, height, waist circumference, supine and standing blood pressure, heart rate, presence of melanoderma, signs of dehydration.
The patient will be given dietary and hygiene advice on fasting and the treatment (gluco- and mineral-corticosteroids) will be adjusted if necessary, in accordance with the recommendations published in 2021 and 2022.
Biological data: urea, iono
During the study period (two weeks), patients will be asked to fill in a monitoring form which will include details of medication taken, waking and bedtimes, physical activity and the occurrence of any discomfort (asthenia, signs of hypoglycaemia, signs of arterial hypotension or other).
Patients will be monitored during the fasting period by one of the investigators by telephone in order to check compliance with the protocol and the possible occurrence of complications.
Criteria for breaking the fasting: occurrence of malaise during fasting, hypoglycaemia diagnosed by CGM, elevation of urea or hyperkalaemia.
Visit 2 : the patients will undergo a clinical examination including quality of life and quality of sleep questionnaires and a physical examination, fasting blood sampling, recovery of the continuous glucose monitoring system and monitoring sheets.
Diagnosis criteria:
- Hypoglycaemia is defined as interstitial glucose measured during CGM < 2.8mmol/l.
- Dehydration is defined by the presence of arterial hypotension (BP <9/6cmHg or orthostatic hypotension) or elevated plasma urea.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non fasting | No intervention | –Non fasting arm: usual diet and behavior |
| Fasting | Experimental | Behavioral: intermittent fastingIntermittent fasting |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary adrenal insufficiency
- Disease duration of at least one year
- Substituted with hydrocortisone and fludrocortisone
- Wishing to fast during the month of Ramadan 2024
Key exclusion criteria (11 listed)
- Diabetes mellitus
- Renal insufficiency
- Hepatic insufficiency
- Cardiac insufficiency
- Respiratory insufficiency
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 |
|---|---|---|
| intermittent fastingAlso: Ramadan fastingfasting from predawn to sunset (no eating and no drinking), for approximately 16 hours. | Behavioural | Fasting |
Primary outcome
hypoglycemia
Time frame: the fasting period from predawn to sunset (approximately 16 hours)
clinical signs or interstitial glucose lower than 2.8mmol/l
1 secondary outcome
Dehydration
Time frame: the fasting period from predawn to sunset (approximately 16 hours)
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 14 Feb 2025.
- Results publication: PubMed 38053731Lee SC, Baranowski ES, Sakremath R, Saraff V, Mohamed Z. Hypoglycaemia in adrenal insufficiency. Front Endocrinol (Lausanne). 2023 Nov 20;14:1198519. doi: 10.3389/fendo.2023.1198519. eCollection 2023.
- Results publication: PubMed 36042975Kawahara T, Tsuji M, Tominaga N, Toyama N, Toda M. Frequency of Adrenal Insufficiency in Patients With Hypoglycemia in an Emergency Department: A Cross-sectional Study. J Endocr Soc. 2022 Aug 4;6(10):bvac119. doi: 10.1210/jendso/bvac119. eCollection 2022 Oct 1.
- Results publication: PubMed 29618670Watanabe T, Ozawa A, Ishii S, Tomaru T, Shibusawa N, Saito T, Yamada E, Horiguchi K, Nakajima Y, Matsumoto S, Yoshino S, Katano-Toki A, Hashimoto K, Mori M, Okada S, Satoh T, Yamada M. Usage of continuous glucose monitoring (CGM) for detecting an unrecognized hypoglycemia and management of glucocorticoid replacement therapy in adult patients with central hypoadrenalism. Endocr J. 2018 May 28;65(5):547-556. doi: 10.1507/endocrj.EJ16-0387. Epub 2018 Apr 4.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Derived from this study: PubMed 42824572Sta J, Chihaoui M, Mabrouk M, Kamoun E, Belhadjsliman C, Khessairi N, Oueslati I, Yazidi M, Chaker F. Ramadan fasting in patients with primary adrenal insufficiency: evaluation of the risk of complications, quality of life and sleep, and associated factors. J Diabetes Metab Disord. 2026 Sep 30;25(2):275. doi: 10.1007/s40200-026-02088-y. eCollection 2026 Dec.
- Derived from this study: PubMed 41108503Chihaoui M, Sta J, Kamoun E, Belhadjsliman C, Khessairi N, Oueslati I, Yazidi M, Chaker F, Feki M. Hypoglycaemia and other risks of ramadan fasting in patients with primary adrenal insufficiency: A prospective controlled trial using 24-hour glucose monitoring. J Endocrinol Invest. 2026 Feb;49(2):359-367. doi: 10.1007/s40618-025-02728-9. Epub 2025 Oct 18.
- Individual participant dataSharing planned: Yes. Data can be shared upon 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 intermittent fasting in people with Primary Adrenal Insufficiency and Intermittent Fasting, 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 11 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 14 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?
hypoglycemia (time frame: the fasting period from predawn to sunset (approximately 16 hours)). 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 NCT06299020, which also lists 8 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 14 Feb 2025.