Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency

NCT06299020 | Completed

• 1 other identifier: HLaRabta24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Primary Adrenal Insufficiency; Intermittent Fasting

Keywords

continuous glucose monitoring; Hypoglycemia; Dehydration

Outcome Measures

Primary Outcomes (1)

• hypoglycemia

  clinical signs or interstitial glucose lower than 2.8mmol/l

  the fasting period from predawn to sunset (approximately 16 hours)

Secondary Outcomes (1)

• Dehydration

  the fasting period from predawn to sunset (approximately 16 hours)

Study Arms (2)

Non fasting

NO INTERVENTION

Non fasting arm: usual diet and behavior

Fasting

EXPERIMENTAL

Intermittent fasting

Behavioral: intermittent fasting

Interventions

intermittent fasting BEHAVIORAL

fasting from predawn to sunset (no eating and no drinking), for approximately 16 hours.

Also known as: Ramadan fasting

Fasting

Eligibility Criteria

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

You may qualify if:

• Primary adrenal insufficiency
• Disease duration of at least one year
• Substituted with hydrocortisone and fludrocortisone
• Wishing to fast during the month of Ramadan 2024

You may not qualify if:

• Diabetes mellitus
• Renal insufficiency
• Hepatic insufficiency
• Cardiac insufficiency
• Respiratory insufficiency
• Use of hypoglycaemic agents
• 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.

Sponsors & Collaborators

• Hopital La Rabta: lead

Study Sites (1)

Hôpital La Rabta

Tunis, 1007, Tunisia

Location

Related Publications (7)

• 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.

  PMID: 38053731 RESULT

• Kawahara 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.

  PMID: 36042975 RESULT

• Watanabe 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.

  PMID: 29618670 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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. 2025 Oct 18. doi: 10.1007/s40618-025-02728-9. Online ahead of print.

  PMID: 41108503 DERIVED

MeSH Terms

Conditions

Addison Disease; Intermittent Fasting; Hypoglycemia; Dehydration

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 7, 2024
• Study Start: March 4, 2024
• Primary Completion: April 20, 2024
• Study Completion: December 1, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after the publication
• Access Criteria: by mail

Locations

TU (1)