Ramadan Fasting in Secondary Adrenal Insufficiency Patients

NCT05827965 | Completed

• 1 other identifier: 1/2023
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Adrenal Insufficiency; Fasting, Intermittent

Keywords

secondary adrenal insufficiency; intermittent fasting; complications; education; glucocorticoid replacement therapy; lifestyle

Outcome Measures

Primary Outcomes (2)

• number of fasted days

  change in the number of fasted days

  one month

• prevalence of complications

  change in the prevalece of complications

  one month

Study Arms (1)

patients with secondary adrenal insufficiency

EXPERIMENTAL

education and treatment adjustment

Behavioral: education and drug adjustement

Interventions

education and drug adjustement BEHAVIORAL

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

patients with secondary adrenal insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hopital La Rabta: lead

Study Sites (1)

University Hospital La Rabta

Tunis, Tunisia

Location

Related Publications (7)

• 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.

  PMID: 34213700 BACKGROUND

• 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.

  PMID: 27878773 BACKGROUND

• 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.

  PMID: 29129244 BACKGROUND

• 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.

  PMID: 32419166 BACKGROUND

• 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.

  PMID: 31552584 BACKGROUND

• Mabrouk 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.

  PMID: 40452492 DERIVED

• Chihaoui 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.

  PMID: 39933257 DERIVED

MeSH Terms

Conditions

Intermittent Fasting

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: before and after education and drug adjustement

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: March 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: March 1, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after the publication of this study

Locations

TU (1)