Risks of Ramadan Fasting in Patients With Primary Adrenal Insufficiency Treated With Prednisolone.

NCT07367425 | Not Yet Recruiting

• 1 other identifier: HLaRabta26
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

In primary adrenal insufficiency (PAI), there is a risk of hypoglycemia and dehydration. These risks seem to be increased during intermittent fasting. A previous study in patients with PAI treated with hydrocortisone at a dose of 20 mg/day showed that the prevalence of hypoglycemia was as high outside (63%) as during Ramadan fasting (71%), and that there was no risk of dehydration. We propose to evaluate the risk of complications during and outside of Ramadan fasting through a prospective study with subjects taken as their own controls, in 35 patients with PAI treated with prednisolone at a dose of 5 mg/day. Patients will undergo an interview, physical examination, blood sampling, and continuous glucose monitoring (CGM) during two weeks of fasting and two weeks of non-fasting.

Conditions

Primary Adrenal Insufficiency; Ramadan Fasting; Prednisolone; Continuous Glucose Monitoring; Hypoglycemia Non-Diabetic; Dehydration

Keywords

primary adrenal insufficiency; Ramadan fasting; continuous glucose monitoring; hypoglycemia; dehydration; glucocorticoid replacement therapy; prednisolone; hypotension

Outcome Measures

Primary Outcomes (2)

• Hypoglycemia

  Diagnosed using continuous glucose monitoring

  during 14 days before Ramdan fasting and 14 days of Ramdan fasting

• Dehydration

  Hypotension and increased serum urea

  During the 14 days before Ramadan fasting and during the 14 days of Ramadan fasting.

Study Arms (2)

Outside Ramadan fasting

NO INTERVENTION

Patients with PAI treated with prednisolone 5mg/day, outside Ramadan fasting

Ramadan fasting

EXPERIMENTAL

Patients with PAI treated with prednisolone 5mg/day during Ramadan fasting.

Other: Ramadan fasting

Interventions

Ramadan fasting OTHER

Ramadan fasting is a religious dry intermittent fasting

Also known as: dry intermittent fasting

Ramadan fasting

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects with primary adrenal insufficiency known for at least one year, treated with a glucocorticoid and a mineralocorticoid, who wish to fast during Ramadan 2026.

You may not qualify if:

• presence of diabetes, renal, hepatic, cardiac, or respiratory insufficiency; use of hypoglycemic agents (sulfonylureas), diuretics, use of any glucocorticoid other than the prescribed replacement therapy; poor disease control (asthenia, malaise, hyperpigmentation, discontinuation of treatment, etc.); pregnancy; breastfeeding; menstruation.

Sponsors & Collaborators

• Hopital La Rabta: lead

Study Sites (1)

University Hospital La Rabta

Tunis, Tunisia

Location

Related Publications (5)

• 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

• 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

• Chihaoui 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.

  PMID: 41108503 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

MeSH Terms

Conditions

Addison Disease; Dehydration; Hypoglycemia; Hypotension

Condition Hierarchy (Ancestors)

Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Melika Chihaoui, Professor

CONTACT

+216 98647327; melika.chihaoui@fmt.utm.tn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endocrinology, Faculty of Medicine of Tunis, University Tunis El Manar. Head of the Department of Endocrinology, University hospital La rabta, Tunis, Tunisia.

Model Details: The study of patients with PAI treated with prednisolone 5mg/day for 14 days before fasting, then during 14 days of Ramadan fasting.

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: January 22, 2026
• Primary Completion: March 22, 2026
• Study Completion: March 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

TU (1)