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CompletedNCT05827965Updated Feb 13, 2025

Ramadan Fasting in Secondary Adrenal Insufficiency Patients

An interventional study of education and drug adjustement in Secondary Adrenal Insufficiency and Fasting, Intermittent, sponsored by Hopital La Rabta. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Hopital La Rabta · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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:

  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.

02

Conditions studied

  • Secondary Adrenal Insufficiency
  • Fasting, Intermittent

Keywords

  • secondary adrenal insufficiency
  • intermittent fasting
  • complications
  • education
  • glucocorticoid replacement therapy
  • lifestyle
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 63 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Hopital La Rabta is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    patients with secondary adrenal insufficiency

    education and treatment adjustment

    Behavioral: education and drug adjustement

Interventions

  • Behavioraleducation and drug adjustement

    education of the patients (lifestyle) and adjustement of glucocorticoid replacement schedule

06

What researchers measure

Primary outcomes

  1. number of fasted days

    change in the number of fasted days

    Time frame: one month

  2. prevalence of complications

    change in the prevalece of complications

    Time frame: one month

07

Study locations

1 site
  • University Hospital La Rabta
    Tunis, Tunisia
08

References and documents

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 34213700 ↗
  • 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. PubMed 27878773 ↗
  • 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. PubMed 29129244 ↗
  • 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. PubMed 32419166 ↗
  • 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. PubMed 31552584 ↗

Individual participant data

Plan to share: Yes — Data can be shared on reasonable request.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05827965
Lead sponsor
Hopital La Rabta
Responsible party
Melika Chihaoui (Professor, Hopital La Rabta) — Principal investigator
First posted
Apr 25, 2023
Start date
Mar 1, 2023
Primary completion
Dec 30, 2023
Completion
Mar 1, 2024
Last update
Feb 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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